Tag: fda

Toothpaste recalled nationwide as FDA issues risk warning
A nationwide recall of more than 40,000 units of toothpaste has received the lowest risk level by the Food and Drug Administration.

A recall for Sensodyne Pronamel Active Shield Toothpaste for Sensitive Teeth began on August 5 over concerns that “Fresh Mint” tubes were mislabeled “Cool Mint/Whitening.” The outer carton was labeled accurately.

FDA inspectors classified the recall as a Class III, the lowest of three risk levels, on Tuesday, indicating the mix-up was “not likely to cause adverse health consequences.”

Newsweek contacted Haleon, which makes Sensodyne, via email on Tuesday.

Why It Matters

The FDA assigned this recall a Class III designation, which applies to situations where the use of or exposure to the recalled product is not likely to cause adverse health consequences. While the FDA determined the risk to be minimal, the corrective move underscores the regulatory attention to food contact safety and manufacturing consistency.

A stock photo shows someone ready to clean their teeth.

Getty Images

What To Know

The FDA recall entry listed the product as Sensodyne Pronamel (potassium nitrate 5 percent, sodium fluoride 0.25 percent) Active Shield Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4 ounces (96.4 grams).

The product came in cases containing six tubes, and the recall affected 46,692 tubes, the FDA alert said.

It added that the products were recalled by New York-based Haleon U.S. Holdings after having been distributed nationwide by GSK Consumer Healthcare.

The FDA’s new classification record listed the recall reason as “labeling.”

“Label Mix-up: The outer carton is labeled Fresh Mint. The tube is labeled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton,” the alert said.

The recall entry included lot and expiration information. The case lot number is 5058RB, and the carton and tube lot number is NJ2A. Both had an expiry date of August 31, 2027.

FDA inspectors carry out a hazard assessment before issuing one of three risk levels. The three classifications are these:
- Class I—a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III—a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
What People Are Saying

The Food and Drug Administration said on its website: “Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any medication or device. Problems with product quality may occur during manufacturing, shipping, or storage. They include … labeling concerns.”

What Happens Next

The FDA lists the recall as ongoing. The alert did not provide consumer return or disposal instructions.
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August 20, 2025
Chemical Safety, Cultivated Meat, and Our Health | NutritionFacts.org

More than 95 percent of human exposure to industrial pollutants like dioxins and PCBs comes from fish, other meat, and dairy.

By cultivating muscle meat directly, without associated organs like intestines, the incidence of foodborne diseases “could be significantly reduced,” as could exposure to antibiotics, “pesticides, arsenic, dioxins, and hormones associated with conventional meat.” Currently, the U.S. Food and Drug Administration has approved seven hormone drugs to bulk up the production of milk and meat. “In the European Union, there exists a total ban on such use,” however. Even without injected hormones, though, animal products naturally have hormones because they come from animals. “Eggs, example given, contribute more to the dietary intake of estradiol [estrogens] than beef, whether the animal is legally treated with hormones or not.” After all, eggs come straight from a hen’s ovaries, so, of course, they’re swimming with hormones. But if you’re directly growing just muscle meat or egg white protein, you don’t need to include reproductive organs, adrenal glands, or any of the associated hormones.

“Chemical safety is another concern for meat produced under current production systems.” There are chemical toxicants and industrial pollutants that build up in the food chain, such as pesticides, PCBs, heavy metals, and ﬂame retardants, but there is no food chain with cultivated meat. We could produce all the tuna we wanted, with zero mercury.

When the World Health Organization determined that processed meat was a known human carcinogen and unprocessed meat a probable human carcinogen, it wasn’t even talking about the carcinogenic environmental pollutants. When researchers tested retail meat for the presence of “33 chemicals with calculated carcinogenic potential,” like polycyclic aromatic hydrocarbons (PAHs), organochlorine pesticides like DDT, and dioxin-like PCBs, they concluded that, in order to reduce the risk of cancer, we should limit beef, pork, or chicken consumption to a maximum of five servings a month.

Why cultivate meat at all when you can just buy organic? Surprisingly, “consumption of organic meat does not diminish the carcinogenic potential associated with the intake of persistent organic pollutants (POPs).” A number of studies have recently compared the presence of environmental contaminants in organic meat versus conventional meat, and the researchers found, surprisingly, that organic meat was sometimes more contaminated. Not only organic beef either. Higher levels were also found in pork and poultry.

If you look at the micropollutants and chemical residues in both organic and conventional meat, several environmental contaminants, including dioxins, PCBs, lead, and arsenic, were measured at signiﬁcantly higher levels in the organic samples. As you can see below and at 2:56 in my video, The Human Health Effects of Cultivated Meat: Chemical Safety, the green is organic meat, and the blue is conventional.

Cooking helps to draw off some of the fat where the PCBs are concentrated, as shown here and at 3:01.

Seafood seems to be an exception. Steaming, for example, generally increases contaminant levels, increasing contaminant exposure and concentrating mercury levels as much as 47 percent, as you can see here and at 3:15 in my video. Better not to have toxic buildup in the first place.

More than 95 percent of human exposure to industrial pollutants like dioxins and PCBs comes from foods like meat, including fatty fish, and dairy, but the pollutants don’t appear magically. The only way the chicken, fish, and other meat lead to human exposure is because the animals themselves built up a lifetime of exposure in our polluted world, from incinerators, power plants, sewer sludge, and on and on, as you can see here and at 3:40 in my video.

Unlike conventional meat production, a slaughter-free harvest would not only mean no more infected animals, but no more contaminated animals either. In terms of pollutants, it would be like taking a time machine back before the Industrial Revolution.

Doctor’s Note:

Cultivated meat means less contamination with fecal residues, toxic pollutants, antibiotics, and hormones; up to 99 percent less environmental impact; and zero pandemic risk. Cultivated meat allows people to have their meat and eat it, too, without affecting the rest of us.

This is the final video in this cultivated meat series. If you missed the first two, check out the videos on Food Safety and Antibiotic Resistance.

I previously did a video series on plant-based meats; see the related posts below.

All videos in the plant-based meat series are also available in a digital download from a webinar I did. SeeThe Human Health Implications of Plant-Based and Cultivated Meat for Pandemic Prevention and Climate Mitigation.

Michael Greger M.D. FACLM

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June 5, 2025
DEA Delivers Gut Punch To Marijuana Industry

The DEA has worked hard to keep marijuana illegal – despite almost 90% believing it shouldn’t be.

The Drug Enforcement Administration (DEA) has work diligently to turn the tide of legal marijuana. An agency built on the “War on Drugs” is doing everything to stop cannabis being available to the population and undercutting a vast amount of their efforts. And now again the DEA delivers gut punch to the marijuana industry. The agency is swimming upstream in the process as it is being recommended by Health and Human Services and the Food and Drug Administration to them to reclassify cannabis in part do to the medical benefits. This goes along the American Medical Association and the American College of Physicians encouraging the federal government to change based proven, science based medical help to a variety of patients including cancer, chronic pain, inflammation and more.

The delay until post-election is do to the DEA’s inability to coordinate the next steps so they pushed the in-person testimony for the upcoming marijuana rescheduling until early next year. DEA director Anne Milligan is seen as anti-marijuana and more inline with House Speaker Mike Johnson (R-LA). When the current administration announced the move to reschedule, Director Milligan had a meeting with key DEA Leaders with “no note taking” and off the record. The DEA not rescheduling would go against the norm as they have always followed HHS and the FDA recommendations.

While both presidential candidates have expressed support for marijuana, a YOUGOV poll has indicated more people have faith in Harris to support the industry. The surprise is the fact is both Democrats (65%) and Republicans (31%) believe her administration would follow through. Pew Research, who has followed the mainstreaming of cannabis, has it at 88+% of the population is for some form of federal legalization. Even AARP has moved toward legalizing marijuana, a key voting block for both parties. But, it seems, the DEA, is against the move and is hoping there is a change of heart in policy making.

In another slap to the cannabis industry, Milligan and the DEA have tried to stack the deck against cannabis. NORML’s Deputy Director Paul Armentano said that he was disappointed but hardly surprised by the DEA’s decision to disproportionately include groups opposed to marijuana policy reform as designated participants. “The fight to end our nation’s outdated and failed cannabis prohibition laws has never been fought on a level playing field,” he said.

Terry Hacienda

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November 1, 2024
Ephedra-Like Weight Loss Minus the Risks | NutritionFacts.org

The diving reflex shows that it’s possible to have selective adrenal hormone effects.

Thermogenic drugs like DNP can cause people to overheat to death; they can increase resting metabolic rates by 300 percent or more. A more physiological spread would range about ten times less, from a 30 percent slower metabolism in people with an underactive thyroid to a 30 percent higher metabolism when the part of our nervous system that controls our fight-or-flight response is activated. In response to a fright or acute stress, special nerves release a chemical called noradrenaline to ready us for confrontation. We experience this by our skin getting paler, cold, and clammy, as blood is diverted to our more vital organs. Our mouth can get dry as our digestive system is put on hold, and our heart starts to beat faster. What we don’t feel is the extra fat being burned to liberate energy for the fight.

That’s why people started taking ephedra for weight loss—“to stimulate the release of noradrenaline from nerve endings.”

Ephedra is an evergreen shrub. It’s been used in China for thousands of years to treat asthma because it causes that same release of noradrenaline that offers relief to people with asthma by dilating their airways. In the United States, it was appropriated for use as a metabolic stimulant, shown to result in about 2 pounds (0.9 kg) of weight loss a month in 19 placebo-controlled trials. By the late 1990s, millions of Americans were taking it. The problem is that it also had all the other noradrenaline effects, like increasing heart rate and blood pressure. So, chronic use resulted in “stroke, cardiac arrhythmia, and death.” The U.S. Food and Drug Administration warned of its risks in 1994, but ephedra wasn’t banned until a decade later after a 23-year-old Major League Baseball pitcher dropped dead. His “autopsy report revealed evidence of ephedra, which the medical examiner said contributed to his death.”

In the current Wild West of dietary supplement regulation, not only can a supplement be “marketed without any safety data” at all, but the manufacturer is under no obligation to disclose adverse effects that may arise. No surprise, then, that online vendors assured absolute safety: “No negative side effects to date.” “No adverse side-effects, no nervous jitters or underlying anxiety, no moodiness…” “100% safe for long-term use.” “It will not interact with medications and has no harmful side effects.” The president of Metabolife International, a leading seller of ephedra, assured the FDA that the company had never received a single “notice from a consumer that any serious adverse health event has occurred…” In reality, it had received about 13,000 health complaints, including reports of serious injuries, hospitalizations, and even deaths.

If only there were a way to get the good without the bad. As I discuss in my video How to Get the Weight Loss Benefits of Ephedra Without the Risks, there is. But to understand it, you first have to grasp a remarkable biological phenomenon known as the diving reflex.

Imagine walking across a frozen lake and suddenly falling through the ice, plunging into the freezing depths. It’s hard to think of a greater, instantaneous fight-or-flight shock than that. Indeed, noradrenaline would be released, causing the blood vessels in your arms and legs to constrict to bring blood back to your core. You can imagine how fast your heart might start racing, but that would be counterproductive because you’d use up your oxygen faster. Remarkably, what happens instead is your heart rate slows down. That’s the diving reflex, first described in the 1700s. Air-breathing animals are born with this automatic safety feature to help keep us from drowning.

In medicine, we can exploit this physiological quirk with what’s called a “cold face test.” To determine if a comatose patient has intact neural pathways, you can apply cold compresses to their face to see if their heart immediately starts slowing down. Or, more dramatically, it can be used to treat people who flip into an abnormally rapid heartbeat. Remember that episode of ER where Carter dunked a patient’s face into a tray of ice water? (That show aired on TV when I was in medical school, and a group of us would gather around and count how many times they violated “universal precautions.”)

What does this have to do with weight loss? The problem with noradrenaline-releasing drugs like ephedra is the accompanying rise in heart rate and blood pressure. What the diving reflex shows is that it’s possible to experience selective noradrenaline effects, raising the possibility that there may be a way to get the metabolic boost without the risk of stroking out. Unbelievably, this intricate physiological feat may be accomplished by the simplest of acts: Instead of drowning in water, simply drink it. Really? Yes, you can boost your metabolism by drinking water. Buckle your safety belts because you are in for a wild ride—one that continues next.

This is the first in a four-part video series. Stay tuned for:

You may also be interested in Friday Favorites: The Best Diet for Weight Loss and Disease Prevention.

Michael Greger M.D. FACLM

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October 29, 2024
Self-administered flu vaccine spray approved by FDA

Self-administered flu vaccine spray approved by FDA – CBS News

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The Food and Drug Administration has approved a “self-administered” influenza vaccine that could be available by next year’s flu season. Dr. Roy Gulick, an infectious disease specialist at New York-Presbyterian Hospital, joins CBS News with more.

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September 23, 2024
Lactaid Milk recalled in 27 states due to trace amounts of almonds not listed on label

Lactaid, a brand of lactose-free dairy milk, has been recalled in 27 states by Massachusetts-based HP Hood LLC because the product may contain trace amounts of almonds that are not listed on the label, according to a recall issued by the U.S. Food & Drug Administration. Those with an allergy or severe sensitivity to almonds could run the risk of serious or life-threatening allergic reactions if the products are consumed, the FDA said.

The 96-ounce containers of Lactaid Milk were shipped to retailers and wholesalers from Sept. 5 to Sept. 18, and located in the following states: Alabama, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming.

The recall applies to a limited number of Lactaid Milk in plastic containers with the code 51-4109 P2 paired with specific “best by dates,” which can be found on the U.S. Food & Drug Administration website.

The issue was discovered as a result of “routine maintenance programs” which revealed the potential for the trace amounts of almond, the FDA said.

No illnesses have been reported.

Consumers who bought the product can return it to the retail location where the purchase was made for a full refund or exchange, or call Hood Consumer Affairs at 1-800-242-2423.

Information on recalls of our FDA-regulated products can be found here.

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September 21, 2024
Is Creatine Safe and Efficient for High Homocysteine? | NutritionFacts.org

Those on a healthy plant-based diet who have elevated homocysteine levels despite taking sufficient vitamin B12 may want to consider taking a gram a day of contaminant-free creatine.

The average blood levels of homocysteine in men are about 1.5 points higher than in women, which may be one of the reasons men tend to be at higher risk for cardiovascular disease. Women don’t need to make as much creatine as men since they tend to have less muscle mass. That may help explain “the ‘gender gap’ in homocysteine levels.” If you remember from my previous video and as seen below and at 0:36 in The Efficacy and Safety of Creatine for High Homocysteine, in the process of making creatine, our body produces homocysteine as a by-product. So, for people with stubbornly high homocysteine levels that don’t respond sufficiently to B vitamins, “creatine supplementation may represent a practical strategy for decreasing plasma homocysteine levels”—that is, lowering the level of homocysteine into the normal range.

It seemed to work in rats. What about humans? Well, it worked in one study, but it didn’t seem to work in another. It didn’t work in yet another either. And, in another study, homocysteine levels were even driven up. So, this suggestion that taking creatine supplements would lower homocysteine was called into question.

However, all those studies were done with non-vegetarians, so they were already effectively supplementing with creatine every day in the form of muscle meat. In that way, researchers were testing higher versus lower supplementation. Those eating strictly plant-based make all their creatine from scratch, so they may be more sensitive to an added creatine source. There weren’t any studies on creatine supplementation in vegans to lower homocysteine until now.

Researchers took vegans who were not supplementing their diets with vitamin B12, so some of their homocysteine levels were through the roof. A few were as high as 50 when the ideal is more like under 10, for example. After taking some creatine for a few weeks, all of their homocysteine levels normalized. You can see the before and after in the graph below and at 2:04 in my video.

Now, they didn’t normalize, as that would have been a level under 10, but that’s presumably because they weren’t taking any B12. Give vegetarians and vegans vitamin B12 supplements, either dosing daily or once a week, and their levels normalize in a matter of months, as you can see below and at 2:20 in my video. However, the fact that you could bring down homocysteine levels with creatine alone, even without any B12, suggests—to me at least—that if your homocysteine is elevated (above 10) on a plant-based diet despite taking B12 supplements and eating greens and beans to get enough folate, it might be worth experimenting with supplementing with a gram of creatine a day for a few weeks to see if your homocysteine comes down.

Why just a single gram? That’s approximately how much non-vegetarians do not have to make themselves; it’s the amount that erased vegetarian discrepancies in blood and muscle, as you can see in the graph below and at 3:01 in my video, and how much has been shown to be safe in the longer term.

How safe is it? We can take a bit of comfort in the fact that it’s “one of the world’s best-selling dietary supplements,” with literally billions of servings taken, and the only consistently reported side effect has been weight gain, presumed to be from water retention. The only serious side effects appear to be among those with pre-existing kidney diseases taking whopping doses closer to 20 grams a day. A concern was raised that creatine could potentially form a carcinogen known as N-nitrososarcosine when it hit the acid bath of the stomach, but, when it actually put to the test, researchers found this does not appear to be a problem.

Bottom line: Doses of supplemental creatine up to 3 grams a day are “unlikely to pose any risk,” provided “high purity creatine” is used. However, as we all know, dietary supplements in the United States “are not regulated by the US Food and Drug Administration and may contain contaminants or variable quantities of the desired supplement” and may not even contain what’s on the label. We’re talking about “contaminants…that may be generated during the industrial production.” When researchers looked at 33 samples of creatine supplements made in the United States and Europe, they found that they all actually contained creatine, which is nice, but about half exceeded the maximum level recommended by food safety authorities for at least one contaminant. The researchers recommend that “consumers give their preference to products obtained by producers that ensure the highest quality control and certify the maximum amount of contaminants present in their products.” Easier said than done.

Because of the potential risks, I don’t think people should take creatine supplements willy-nilly, but the potential benefits may exceed the potential risks if, again, you’re on a healthy plant-based diet and taking B12, and your homocysteine levels are still not under 10. In that case, I would suggest giving a gram a day of creatine a trying to see if it brings it down.

The reason I did this whole video series goes back to “Risks of Ischaemic Heart Disease and Stroke in Meat Eaters, Fish Eaters, and Vegetarians Over 18 Years of Follow-Up: Results from the Prospective EPIC-Oxford Study,” which found that, although the overall cardiovascular risk is lower in vegetarians and vegans combined, they appeared to be at slightly higher stroke risk, as you can see in the graph below and at 5:06 in my video.

I went through a list of potential causes, as you can see at 5:11 and below, and arrived at elevated homocysteine. What’s the solution? A regular, reliable source of vitamin B12. The cheapest, easiest method that I personally use is one 2,500 mcg chewable tablet of cyanocobalamin, the most stable source of B12, once a week. (In fact, you can just use 2,000 mcg once a week.) And, again, a backup plan for those doing that but still having elevated homocysteine is an empirical trial of a single gram a day of creatine supplementation, which was shown to improve at least capillary blood flow in those who started out with high homocysteine levels.

In sum, plant-based diets appear to “markedly reduce risk” for multiple leading killer diseases—heart disease, type 2 diabetes, and many common types of cancer—but “an increased risk for stroke may represent an ‘Achilles heel.’ Nonetheless, vegans have the potential to achieve a truly exceptional ‘healthspan’ if they face this problem forthrightly by restricting salt intake and taking other practical measures that promote cerebrovascular [brain artery] health…Nonetheless, these considerations do not justify nutritional nihilism. On balance, low-fat vegan diets offer such versatile protection for long-term health that they remain highly recommendable. Most likely, the optimal strategy is to adopt such a [plant-based] diet, along with additional measures—appropriate food choices, exercising training, judicious supplementation [of vitamin B12]—that will mitigate the associated stroke risk.” And try not to huff whipped cream charging canister gas. Leave the “whippets” alone.

This concludes my series on stroke risk. If you missed any of the other videos, see the related posts below.

I’m assuming that nearly everyone taking their B12 will have normal homocysteine levels, so these last two videos are just for the rare person who doesn’t. However, those on a healthy plant-based diet with elevated homocysteine levels despite taking sufficient vitamin B12 should consider taking a gram a day of contaminant-free creatine, which should be about a quarter teaspoon.

Where do you get contaminant-free creatine? Since regulations are so lax, you can’t rely on supplement manufacturers no matter what they say, so I would recommend going directly to the chemical suppliers that sell it to laboratories and guarantee a certain purity. Here are some examples (in alphabetical order) of some of the largest companies where you can get unadulterated creatine: Alfa Aesar, Fisher Scientific, Sigma-Aldrich, and TCI America.

Michael Greger M.D. FACLM

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September 17, 2024
Dense or not dense: Md. physician says updates to mammogram readings now required by FDA help empower women – WTOP News
A new requirement from the FDA aims at helping detect breast cancer. A local doctor gives us details on what this means for women and mammogram results.
A new requirement from the Food and Drug Administration for radiology facilities nationwide aims to help better detect breast cancer.

Radiology reports for breast cancer detection are now required to say whether a patient’s breast tissue is “dense” or not.

What does that mean?

“I liken it to the sky: So the sky is blue and the clouds are white, so breast density essentially is white, and the cloudier the sky, the harder it is to find lesions, because cancer is white and breast tissue is white,” said Dr. Michelle Townsend-Day, chief of breast imaging for MedStar Union Memorial and MedStar Good Samaritan hospitals in Baltimore, Maryland.

According to the FDA, the mammography report needs to include an overall assessment of breast density, classified in one of the following categories:
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses.”
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
Townsend-Day said the FDA’s new requirement for all reports is good news for women nationwide. It gives them the tools, she said, to take that next step in their health if the report shows the density of the breast tissue makes it hard to read.

“They can contact their primary care physician or provider, so they can have an in-depth discussion of what that means and what extra imaging they should have or not have depending on their breast density,” she told WTOP.

Townsend-Day said she believes it empowers women to keep better track of their breast health and the risks of cancer.

“I hope this allows patients overall to take more ownership of their health and to advocate for themselves as it relates to their overall increased breast cancer risk. Because breast density does confer a slightly elevated risk of developing breast cancer over time, as well as the masking effect, meaning hiding breast cancers,” Townsend-Day said.

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© 2024 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.
Valerie Bonk

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September 10, 2024
Is CBN Right For You

Sitting at the crossroads of THC and CBD – CBD helps with sleep and pain. Could it be right for you?

Marijuana is been proven a benefit to the medical world and the American Medical Association, Health and Human Services, the American College of Physicians and the Food and Drug administration all support increasing it’s reach and for more research. It has been shown to be particularly helpful with chronic pain, nausea, and sleep. The cannabis plant provide a variety of cannabinols, including CBD, marijuana and CBN. But the medical question is CBN right for you? It sits at the crossroads between CBD and THC can be useful with health issues.

RELATED: Science Says Medical Marijuana Improves Quality Of Life

Like CBD and THC, CBN is among the 100+ molecules in the cannabis plant. When THC is heated and exposed to CO2 (oxygen), it converts to CBN. The compound is said to have a mild psychoactive effect, slightly more so than CBD but much less than THC. Specifically, it is said to have a sedating effect on most users and to have promising sleep aid applications, similar to melatonin (among other potential uses).

Photo by Bacsica/Getty Images

The marketing of CBN as a dietary supplement may be viable, provided that no unapproved health claims are made and could be nationally legal as long as they have a THC concentration of 0.3% or less. Unlike CBN and like THC, CBN is legal in some states, but not federally. The FDA likes to point out that the 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food Drug & Cosmetic Act (“FDCA”) and section 351 of the Public Health Service Act. But the marketing of CBN as a dietary supplement may be viable nonetheless, provided that no unapproved health claims are made.

RELATED: What Is CBG And Is It Legal?

Unlike CBD, CBN not been approved as a drug, and FDA itself has acknowledged “parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of the [drug exclusion rule].” As with CBG, if CBN is approved as a drug at some point down the line, it also seems likely that the drug exclusion rule would not apply: this is because the rule contains an exception for substances marketed as foods or dietary supplements prior to any FDA clinical investigation. People are already marketing CBN products as foods and dietary supplements.

Photo by Adrianna Calvo via Pexels

But the question is still, is CBN right for you? With regards to sleep, it is can be a bit stronger than CBD alone. While melatonin is a known as a good over the counter sleep aid, it doesn’t work for everyone.

A clinical study looked into sleep improvements from 15 mg of CBD with or without 15 mg of CBN compared with 5 mg of melatonin. In the study, all groups reported improved sleep quality, and there were no significant differences between products. Since this study didn’t look at CBN alone, it isn’t a direct comparison. But it seems to indicate that products containing an equal amount of CBD and CBN are similarly effective to melatonin for sleep. And adding a CBD/CBN product to melatonin didn’t provide any added benefit.

RELATED: Science Says Medical Marijuana Improves Quality Of Life

CBN use showed relief in muscle and joint pain conditions with inflammation. Limited studies show The study also noted that pain relief was better when CBD and CBN were used together.

So CBN can be helpful if you need a little extra in over the counter help.

Amy Hansen

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September 3, 2024
The FDA Approves Two New COVID-19 Vaccines As Cases Remain On The Rise

On Thursday, The U.S. Food and Drug Administration announced two new updated COVID-19 vaccines as cases tied to the largest spike in infections within the last two years remain high across the country.

The vaccines, manufactured by Pfizer-BioTech and Moderna, target the KP.2 variant — one of the FLiRT variants — a descendant of the highly contagious JN.1 Omicron variant.

The agency advised manufacturers that the updated vaccines should be monovalent vaccines that attack the selected strain to provide adequate protection against circulating variants after evaluating the recent uptick in infections.

Initially, the FDA suggested they target JN.1, but the agency altered its suggestion after reviewing updated data.

According to the U.S. Centers for Disease Control and Prevention, the current predominant strain of the virus is KP.3.11, another FLiRT variant. It has overtaken its parent lineage, KP.3, and previous dominant KP.2 variants.

Within the first two-week period of August, KP.3.11 accounted for approximately 31 to 43 percent of cases across the country. Although the updated vaccines target KP.2, they’ve been proven to be significantly more effective against the JN lineage than the vaccines currently available.

The CDC recommends that anyone six months and older receive an updated vaccine regardless of their previous vaccination status. Pfizer-BioTech and Moderna’s updated vaccines — Comirnaty and Spikevax — are available for people six months and older.

Novavax is working on a third vaccine that follows the FDA’s original recommendation by aiming to protect against the earlier JN.1 variant. The agency is expected to approve this vaccine soon, and it will be available to people 12 years of age and older.

Pfizer-Biotech and Moderna are expected to begin shipments of the vaccine to distributors within the coming days. The updated vaccines could cost up to $150 per dose for those paying out of pocket. However, most public and private health insurance plans should cover this cost.

Some uninsured adults may have issues accessing the vaccine at no cost or at a lower cost as the CDC’s Bridge Access Program — which covers the costs of some vaccinations for those without coverage — could end in August.

Those who rely on this program can opt to get their vaccines at community health centers or clinics, where they may be free or offered at a reduced rate.

Faith Bugenhagen

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August 22, 2024
FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

A company seeking to treat post-traumatic stress disorder with a combination of MDMA and talk therapy just suffered a major setback from the U.S. Food and Drug Administration.

Lykos Therapeutics, the firm aiming for FDA approval, said on Friday that it received a rejection letter from the agency, which called for more research into the potential treatment’s safety and efficacy. Lykos said in response that it wants the FDA to reconsider the decision, adding that it will request a meeting to “further discuss the agency’s recommendations for a resubmission.” MDMA, also known as molly and ecstasy, is a lab-made drug developed more than a century ago by a chemist at the German pharmaceutical giant Merck.

The decision follows an earlier vote from FDA advisors, who rejected the MDMA-assisted therapy in June. The panel questioned the treatment’s long-term efficacy and safety, the quality of Lykos’ data, and the conduct of therapists who participated in earlier Lykos studies. While the FDA had the option to act against its panel’s feedback, the agency reportedly reached a similar conclusion.

According to Lykos CEO Amy Emerson, conducting a third phase 3 trial would set the firm back several years. Calling the FDA’s letter “deeply disappointing,” Emerson argued in a statement that the agency’s requests “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

Lykos did not publish the rejection letter, and the FDA did not immediately respond to Gizmodo’s request for more information. However, a spokesperson for the agency told NPR on Friday, “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”

The spokesperson added that the agency “will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”

Harri Weber

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August 10, 2024
The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

The US Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.

Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulatory agency has requested an additional Phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel in June concluded that there wasn’t enough evidence to recommend its approval.

Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Lykos CEO Amy Emerson in a company statement. She added that conducting another Phase 3 trial would take several years.

As many as 13 million Americans suffer from PTSD in any given year, according to the National Center for PTSD. Just two drugs have been specifically approved to treat the disorder, with the latest being greenlit by the FDA in 2000. The lack of options has turned combat veterans into unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pressed for its approval.

In a letter to President Biden, more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for veterans and their families, with the potential to save and drastically improve countless lives over the coming years.”

A bipartisan group of more than 60 members of the House of Representatives and 19 senators also voiced their support for the therapy this week. “Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful,” the lawmakers wrote in a letter to FDA commissioner Robert Califf.

There has been increasing interest in recent years in using MDMA and other psychedelics to treat severe mental illness. But with the FDA decision, MDMA will remain a federally prohibited substance listed as Schedule I drug, defined as those that have “no currently accepted medical use and a high potential for abuse.”

During a nine-hour meeting on June 4, Lykos representatives made their case to an independent panel of FDA advisers. The company’s clinical trial data showed that more than 86 percent of study participants who underwent MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough that they no longer met the criteria for a diagnosis. In a placebo group, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.

Despite the positive results, advisory committee members cited concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of the talk therapy given during the MDMA sessions. One major question raised by the advisory committee was the extent to which the talk therapy contributes to the treatment benefit.

The panel overwhelmingly voted that there wasn’t enough evidence to recommend approval. Just two of the 11 committee members agreed that MDMA-assisted therapy is effective based on the evidence Lykos presented, and only one thought its benefits outweighed the risks. The FDA usually follows the recommendations of advisory committees but is not obligated to do so.

Lykos said it will “work diligently in the coming months to address FDA’s concerns and to take advantage of agency processes to resolve scientific disagreements.”

Emily Mullin

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August 9, 2024
It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It

Eli Lilly and Novo Nordisk have both recently taken legal action against companies selling compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly initiated six lawsuits, following 10 other lawsuits that the pharmaceutical company began last fall. In one, filed against a company selling compounded GLP-1s online, it alleged that passing compounded drugs off as having identical active ingredients as its products was “not merely deceptive—it’s dangerous.”

“Telehealth providers and compounding pharmacies that are claiming to offer or sell unapproved compounded products claiming to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “As the FDA has cautioned, unapproved compounded ‘semaglutide’ drugs do not have the same safety, quality, and effectiveness assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded drug if an approved drug is available.”

“There’s huge safety implications,” Ryder says. In 2012, a compounding pharmacy caused a fungal meningitis outbreak that killed at least 64 people, among the worst pharmaceutical drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of this medicine was sentenced to prison time, and the event led to tightened oversight and licensing requirements for compounders.

Some of the leading compounding pharmacies that produce GLP-1 medications have landed in trouble for their practices. Hallandale Pharmacy, a popular supplier—two of my four vials came in its sleek blue packaging—has run into trouble with regulators for past infractions, which included concerns over record-keeping and facility conditions. It has received warning letters from the FDA, although the last one was closed out in May 2022, which means the FDA found that it had addressed outstanding issues. (Hallandale declined requests for comment.)

The FDA has found issues with pharmaceutical companies, too, though. In 2023, FDA inspectors found bacterial contamination at a Novo Nordisk production plant in North Carolina. “Leadership addressed immediately, and the site received FDA approval for full production for market in August 2023,” Novo Nordisk’s Bennett says.

Compounding advocates say that, although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part due to post-2012 rule changes. Carroll, for example, says Hims did “due diligence” when choosing its pharmacy and that it has been satisfied with the medication quality. “We’ve seen an extremely good response from our customers,” he says. “No untoward side effects that we didn’t anticipate.” According to Carroll, Hims has not had to report any adverse effects to the FDA.

What’s Next?

As researchers continue to discover new potential use cases for GLP-1 drugs, and public interest and demand remains high, these drugs may be on the FDA’s official shortage list for months or even years to come. If the shortage ends, one type of compounding pharmacy (called 503a) would be required to stop production immediately, while 503b pharmacies, which typically produce on a larger scale, would have 60 days. An end to the shortage would require some substantial pivots within this booming cottage industry. None of the telehealth companies that sent compounded semaglutide to WIRED made mention of what might happen in this scenario during the intake process.

Many people who take compounded drugs may be taken by surprise if they are told they must switch to brand names—and pay much higher prices—within a matter of months.

However, even when the shortage does officially end, at least some of the telehealth companies do not plan to pivot from compounding. “We believe there’s going to be more and more demand for the medication, so that may actually prolong the shortage list,” says Hims’ Pat Caroll. “We are convinced there’s a pathway, even when it comes off the shortage list, to supply these compounded medications.”

Even compounding skeptics suspect that it’s not going away anytime soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the US population” before shortages end. Until then, Ryder suspects this telehealth boom will continue unabated.

For now, the vials of compounded semaglutide WIRED ordered are sitting in the back of a fridge untouched.

Kate Knibbs

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July 12, 2024
Marylander among those made ill by microdosing candies behind nearly 50 illnesses – WTOP News

Food and Drug Administration officials said dozens of people have been made ill, including one person in Maryland, after consuming Diamond Shruumz.

This image provided by the U.S. Food and Drug Administration shows Diamond Shruumz-brand products which have been recalled in June 2024. At least 48 people in 24 states said they got sick after eating Prophet Premium Blends LLC’s products including chocolate bars, cones and gummies, the U.S. Food and Drug Administration said Tuesday, July 2, 2024. One death is “potentially associated” with the outbreak and 27 people have been hospitalized, the agency said. (FDA via AP)

This image provided by the U.S. Food and Drug Administration shows Diamond Shruumz-brand products which have been recalled in June 2024. At least 48 people in 24 states said they got sick after eating Prophet Premium Blends LLC’s products including chocolate bars, cones and gummies, the U.S. Food and Drug Administration said Tuesday, July 2, 2024. One death is “potentially associated” with the outbreak and 27 people have been hospitalized, the agency said. (FDA via AP)

Food and Drug Administration officials said dozens of people have been made ill, including one person in Maryland, after consuming Diamond Shruumz — a microdosing candy and gummy brand.

Officials began an initial investigation on June 7, after receiving eight reports of illness connected with the brand’s chocolate bars. Those cases grew to include one unidentified Marylander by June 18, more than a week before the Santa Ana, California-based Prophet Premium Blends, issued a recall for the product.

“As of July 1, 2024, a total of 48 illnesses have been reported from 24 states,” the FDA said in a July 2 update.

Agency officials said that recalled products were sold online and in person at location across the U.S., including retails stores, smoke/vape shops and stores that sell hemp-derived products like CBD or delta-8 THC.

The ingredient muscimol, which is found in some types of mushrooms, is believed to be linked with symptoms such as seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension, reported by people who got sick.

FDA investigators said they believe that a death may be related to consumption of one of the products, but the FDA has yet to confirm the details of that report.

U.S. Centers for Disease Control and Prevention, FDA and America’s Poison Center investigators continue to look into the reports, and encourage anyone with symptoms to reach out to their health provider or the Health Resources & Services Administration Poison Help line at 1-800-222-1222.

The Associated Press contributed to this report.

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© 2024 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

Ivy Lyons

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July 7, 2024
FDA gives green light to menthol flavored e-cigarettes for first time

What teens and parents should know about the dangers of vaping

What teens and parents should know about the dangers of vaping

03:53

The Food and Drug Administration on Friday authorized menthol-flavored electronic cigarettes for adult smokers, the first time the agency has opened the door for vaping companies to sell non-tobacco flavored products.

The FDA cleared Njoy, a vaping brand recently acquired by tobacco giant Altria, to market four menthol e-cigarettes. But regulators also said it would review applications for authorization of flavored e-cigarettes on a case-by-case basis and that its actions apply on to Njoy’s four products.

In announcing its decision, the FDA said it found that menthol-flavored e-cigarettes can reduce the harms of traditional tobacco smoking. But the agency emphasized that it is not approving menthol vaping products, which would mean the FDA had determined a drug is safe and effective for its intended use. Instead, authorization by the agency only means Njoy has received regulatory approval to market its products to the public.

“We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” Matthew Farrelly, director for the FDA’s Center for Tobacco Products, said in a statement. “Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth.”

The decision lends new credibility to vaping companies’ long-standing claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease.

Parent groups and anti-tobacco advocates immediately criticized the decision, which comes after years of pushing regulators to keep menthol and other flavors that can appeal to teens off the market.

“This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children.”

Vaping just one time could put you at higher risk for heart failure, study says

00:45

Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn’t widely used by young people who vape.

Njoy is one of only three companies that previously received the FDA’s OK for vaping products. Like those products, the menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

The Njoy approval is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. Currently the U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

—The Associated Press contributed to this report.

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June 21, 2024
Children’s Cereals: Candy for Breakfast? | NutritionFacts.org

Plastering front-of-package nutrient claims on cereal boxes is an attempt to distract us from the incongruity of feeding our children multicolored marshmallows for breakfast.

The American Medical Association started warning people about excess sugar consumption more than 75 years ago, based in part on our understanding that “sugar supplies nothing in nutrition but calories, and the vitamins provided by other foods are sapped by sugar to liberate these calories.” So, added sugars aren’t just empty calories, but negative nutrition. “Thus, the more added sugars one consumes, the more nutritionally depleted one may become.”

Given the “totality of publicly available scientific evidence,” the Food and Drug Administration (FDA) decided to make processed food manufacturers declare “added sugars” on their nutrition labels. The National Yogurt Association was livid and said it “continues to oppose the ‘added sugars’ declaration,” since it needed “‘added sugars’ to increase palatability” of its products. The junk food association questioned the science, whereas the ice cream folks seemed to imply that consumers are too stupid to “understand or know how to use the added sugar declaration,” so it’s better just to leave it off. The world’s biggest cereal company, Kellogg’s, took a similar tact, opposing it so as not “to confuse consumers.” Should the FDA proceed with such labeling against Kellogg’s objections, the cereal giant pressed that “an added sugars declaration…should be communicated as a footnote.” It claimed that its “goal is to provide consumers with useful information so they can make informed choices.” This is from a company that describes its Froot Loops as “packed with delicious fruity taste, fruity aroma, and bright colors.” Keep in mind that Froot Loops has more sugar than a Krispy Kreme doughnut, as you can see in the graph below and at 1:46 in my video Friday Favorites: Kids’ Breakfast Cereals as Nutritional Façade.

Froot Loops is more than 40 percent sugar by weight! You can see the cereal box’s Nutrition Facts label below and at 1:50 in my video.

The tobacco industry used similar terms, such as “light,” “low,” and “mild” to make its products appear healthier—before it was barred from doing so. “Now sugar interests are fighting similar battles over whether their terminology, including ‘healthy,’ ‘natural,’ ‘naturally sweetened,’ and even ‘lightly sweetened,’ is deceptive to consumers.”

But if you look at the side of a cereal box, as shown below and at 2:13 in my video, you can see all those vitamins and minerals that have been added. That was one of the ways the cereal companies responded to calls for banning sugary cereals. General Mills defended the likes of Franken Berry, Trix, and Lucky Charms for being fortified with essential vitamins.

Sir Grapefellow, I learned, was a “grape-flavored oat cereal” complete with “sweet grape star bits”—that is, marshmallows. Don’t worry. It was “vitamin charged!” You can see that cereal box below and at 2:31 in my video.

Sugary breakfast cereals, said Dr. Jean Mayer from Harvard, “are not a complete food even if fortified with eight or 10 vitamins.” Senator McGovern replied, “I think your point is well taken that these products may be mislabeled or more correctly called candy vitamins than cereals.”

Plastering nutrient claims on cereal boxes can create “a ‘nutritional façade’ around a product, acting to distract attention away” from unsavory qualities, such as excess sugar content. Researchers found that the “majority of parents misinterpreted the meaning of claims commonly used on children’s cereals,” raising significant public health concerns. Ironically, cereal boxes bearing low-calorie claims were found to have more calories on average than those without such a claim. The cereal doth protest too much.

Even candy bar companies are getting in on the action, bragging about protein content because of some peanuts. Like the Baby Ruth, a candy bar that has 50 grams of sugar. Froot Loops could be considered breakfast candy, as the same serving would have 40 sugar grams, as you can see below and at 3:45 in my video.

Given that “research suggests that consumers believe front-of-package claims, perceive them to be government-endorsed, and use them to ignore the Nutrition Facts Panel,” there’s been a call from nutrition professionals to consider “an outright ban on all front-of-package claims.” The industry’s short-lived “Smart Choices” label, as you can see below and at 4:13 in my video, was met with disbelief when it was found adorning qualifying cereals like Froot Loops and Cookie Crisp. The processed food industry spent more than a billion dollars lobbying against the adoption of more informative labeling (a traffic-light approach), “opposing most aggressively the use of a red light suggesting that any food was too high in anything.”

I was invited to testify as an expert witness in a case against sugary cereal companies. (I donated my fee, of course.) Check out the related posts below for a video series and blogs that are a result of some of the research I did.

You may also be interested in videos and blogs on the food industry; see related posts below.

Michael Greger M.D. FACLM

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June 11, 2024
Psychedelic Drug MDMA Faces Questions As FDA Considers Approval For PTSD – KXL

WASHINGTON (AP) — Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD.

The Food and Drug Administration posted its review of the drug on Friday, raising questions about its effectiveness and potential risks, including heart problems.

The drug application is part of a decades-long effort by advocates to move psychedelic drugs into the medical mainstream.

If approved, MDMA would be made available to certified doctors and therapists.

It’s the first in a series of psychedelics that are heading before the FDA after studies suggesting their potential to treat conditions like depression, addiction and anxiety.

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Grant McHill

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May 31, 2024
Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations

WASHINGTON, May 20, 2024 (Newswire.com)
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Fragrance Creators Association (FCA) President and CEO Farah K. Ahmed issued the following statement on funding to support the Food and Drug Administration’s (FDA) implementation of the Modernization of Cosmetics Regulation Act (MoCRA):

“FCA is asking Congress to provide at least $8 million for the FDA’s work to implement MoCRA in fiscal year 2025 (FY25). MoCRA ushered in a new era in cosmetics regulations but its success hinges on adequate funding. Consequently, FCA submitted letters to Congress today urging it to prioritize sound science, safety, and innovation and appropriate at least $8 million for FY25.

“Fragrance plays an essential role in cosmetics and personal care products, products that nurture skin health and hygiene, empower self-expression, lift confidence, and more. Sufficient funding for FDA to implement MoCRA will support responsible fragrance industry innovation, uphold safety, increase consumer confidence in the products they know and love, and advance environmental sustainability.”

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Fragrance Creators Association is the trade association representing the majority of fragrance manufacturing in North America. We also represent fragrance-related interests along the value chain. Fragrance Creators’ member companies are diverse, including large, medium, and small-sized companies that create, manufacture, and use fragrances and scents for home care, personal care, home design, fine fragrance, and industrial and institutional products, as well as those that supply fragrance ingredients, including natural extracts and other raw materials that are used in perfumery and fragrance mixtures. Fragrance Creators established and administers the Congressional Fragrance Caucus, ensuring ongoing dialogue with members of Congress and staff. Fragrance Creators also produces The Fragrance Conservatory, the comprehensive digital resource for high-quality information about fragrance—www.fragranceconservatory.com. Learn more about Fragrance Creators at fragrancecreators.org—for people, perfume, and the planet.

Source: Fragrance Creators Association

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May 20, 2024
5 Key Things To Check On A CBD Label

Science and the public have been good to CBD. It helps with the ever popular issue of sleeping and it can help reduce anxiety. Discreet, convenient and semi fast acting – it can be a help mate for first dates, stressful family events, or just rough days. The CBD/cannabis Epidiolex has been proven to reduce seizures and is the first cannabis-derived medicine approved by the FDA. So lots of benefits, but since it is still a bit of a newbie on shelves…you need to be careful of what you buy. Here are 5 key tags to check on a CBD label.

RELATED: How To Use CBD For A Better Night’s Sleep

Reading product labels is often confusing, overly technical and filled with materials no one understands. Add to the mix the fact CBD is still in FDA limbo, and you need a list like this to point you in the right direction. Here are 5 things to check when reading a CBD label.

Make sure CBD is in on the label and in the product

First thing’s first: make sure there’s actually CBD in your CBD product. Today’s CBD landscape is filled with products that claim to contain CBD while really containing just hemp oil, or lie about the amount of CBD they contain. Look for either CBD or cannabidiol and be wary of products containing hemp seeds, cannabis sativa, hemp seed oil, etc. Although these ingredients sound weedy, they’re not the same thing as CBD.

Photo by IRA_EVVA/Getty Images

Check the dosage and ingredients

Dosage in key in how effective it will be. Be understanding it you time the amount you need then time out when you might want to take it again. Additionally, look for a full list of ingredients, including the carrier oil used. Check for any potential allergens or additives you want to avoid.

RELATED: 5 Uses For Hemp Besides CBD Oil

Keep an eye out for COA

COAs guarantee the product you’re looking at has been tested by a third party facility that has no relationship to the maker. Their results are unbiased and thus trust worthy. Reputable companies should feature this information on their labels, which should come in the shape of a bar code and should be easily accessed via smartphone. If this isn’t the case, the COA should appear on the product’s website.

Photo by Sabrina Rohwer via Pexels

Look for the CBD oil source

One of the first red flags of fake CBD products is a label that’s vague or doesn’t state where the CBD oil was sourced. CBD can be sourced from cannabis plants or industrial hemp, and most quality products tend to be “full spectrum,” “broad spectrum,” or “CBD isolate.”

Know your cannabis state laws

This is important since CBD label requirements vary by state, with the best labels being from products sold in areas where marijuana is legal. If you’re purchasing a product from out of a legal state, these packages should at least imitate how regulated products look.

Sarah Johns

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May 8, 2024
No One Knows How Far Bird Flu Has Spread

In late March, the US Department of Agriculture (USDA) announced it had detected cases of bird flu in dairy cattle. Initially discovered in dairy farms in Texas, Kansas, and New Mexico, there are now 36 confirmed outbreaks in dairy herds in nine states.

Although the H5N1 virus circulates widely in wild birds, it is now circulating among dairy cattle in the US. The USDA has confirmed transmission between cows in the same herd, from cows to birds, and between different dairy cattle herds.

But the reported outbreaks are likely to be a major underestimation of the true spread of the virus, says James Wood, head of veterinary medicine at the University of Cambridge. “It’s likely there is going to be a fair amount of underreporting and underdiagnosis,” he says.

Tests by the Food and Drug Administration (FDA) of retail milk samples might give some indication of how widespread the virus is. The agency found viral fragments in one in five samples of commercial milk, although this virus had been deactivated by pasteurization so was not infectious.

So far there is only one confirmed human infection in the outbreak: someone in Texas who had close contact with dairy cattle. Their only reported symptom was conjunctivitis, and the individual was told to isolate themselves and take an antiviral drug for flu. But anecdotal reports of illness on dairy farms hints that infections among humans may be more widespread than official data suggests. Although human infections have tended to be rare, the virus is dangerous—just over half of the human cases recorded by the World Health Organization over the past two decades have been fatal.

Dairy workers are most at risk of possible infection in the current outbreak, but understanding the extent of any infections is extremely tricky, says James Lawler, professor of infectious diseases at University of Nebraska Medical Center. More than half of workers in the US dairy industry are immigrants, and many of them are undocumented.

These undocumented workers are unlikely to want to put themselves at risk by coming for testing, Lawler says. “There’s an inherent disincentive that many of the workers, because of their status as undocumented immigrants, are not raising their hands.” The result, Lawler says, is that it’s difficult for scientists to track any possible spread of the virus through humans.

Another issue is incentivizing owners of dairy farms to report when their animals seem sick. The USDA Animal and Plant Health Inspection Service specifically provides payments for poultry farmers who have to kill their livestock due to bird flu infections. Dairy farmers don’t get compensated for reporting infections, which incentivizes producers to keep quiet, upping the risk that outbreaks get out of hand and spread to other cattle or farm workers.

This presents a major problem for tracking the spread of the disease. “From the perspective of a producer, how is it going to benefit them to share or even test and understand if there’s a virus circulating in their herd?” Lawler says.

Matt Reynolds

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May 3, 2024