In a warning letter sent to Amazon, dated Dec. 20, 2023, the Agency states that lab analysis of seven different products purchased through the online retail giant revealed the presence of sildenafil and tadalafil, phosphodiesterase type-5 (PDE-5) inhibitors and the active pharmaceutical ingredients in Viagra and Cialis, respectively. Both ingredients are used to treat erectile dysfunction (ED).
"These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels," the FDA stated in the letter, which is signed by Jill Furman, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research (which regulates drugs), and Ann Oxenham, JD, director of the Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition (which regulated foods and dietary supplements).
The Agency named the products as: "MANNERS Energy Boost", “Round 2", "WeFun", "Genergy", "Big Guys Male Energy Supplement", "Mens Maximum Energy Supplement" and "X Max Triple Shot Energy Honey". The Agency issued public notifications warning consumers about the products earlier in 2023.
All of the products were labeled as dietary supplements with a Supplements Facts panel, except "X Max Triple Shot Energy Honey", which was labeled as a food with a Nutritional Information panel.
The FDA letter also noted that "there is a potential for serious health risks associated with these products, particularly since anyone who takes these products would be unaware of the presence of the undeclared drug ingredients and placed at risk for the associated adverse events."
NutraIngredients-USA contacted Amazon for comment but did not receive a response prior to publication.
Claims
Interestingly, FDA alleged that the offending products carried claims that "establish the intended use of these products as drugs include", and the letter went on to cite claims such as "Energy Boost", "STRENGTH * ENERGY * ENDURANCE", "Energy[,] Performance" and "ENERGY FOR MEN".
None of these claims directly mention sexual performance, and any of them could be claims found on many sports/energy supplements, so does this indicate that such claims are not permitted as structure/function claims on any dietary supplement product, asked Loren Israelsen, president and founder of the United Natural Products Alliance (UNPA).
When asked to comment on this point by NutraIngredients-USA, a spokesperson for the FDA said: “Because the products cited in this warning letter contain sildenafil or tadalafil, they are excluded from the definition of 'dietary supplement' under section 201(ff) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Thus, the dietary supplement authorities are not applicable.
“Accordingly, section 403(r)(6) of the FD&C Act, describing 'structure/function' claims for dietary supplements, does not apply and the claims listed in the warning letter cause the products to be unapproved new drugs.”
"Amazon needs to ensure that all dietary supplements are held to that same standard"
Commenting on the warning letter, Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), told us: "The FDA warning letters to Amazon should greatly concern them. Our members are committed to ensuring the products they bring to the platform meet the highest standards of quality and safety. But Amazon needs to also ensure that all products marketed as dietary supplements in their online marketplaces are held to that same standard. To not insist on these good practices, across the board, sullies our industry’s reputation and disadvantages those companies who spend the money to assure their compliance on the platform.”
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), said that the warning letter harks back to a letter from then FDA Commissioner Margaret Hamburg, MD, in 2010.
“This isn’t new policy from FDA, and while it’s important to see, it draws out the finer point that the direction and magnitude of involvement and engagement in the industry from such platforms needs to change, and change quickly and in a wholesale manner," he said.
“Whether it’s the latest industry self-policing by testing unfamiliar brands (on Amazon) or the finding of counterfeits, the question is one of somebody just interested in property in the neighborhood versus actually being a member and supporter of the community. We’ve allowed and, in many cases, welcomed the former for far too long without any real commitment or engagement to the community, and the cost is credibility. Lawmakers looking to make a name for themselves use stories like these to damn the entire industry."
Testing
Industry testing of dietary supplement products on Amazon and elsewhere has been going on for several years. Most notably, Illinois-based natural products manufacturer NOW has performed 16 rounds of testing of lesser-known brands on the platform, putting a range of supplement segments under the proverbial microscope. ChromaDex has also raised questions about the quality of NMN supplements on Amazon, while Timeline (formerly Amazentis) has alleged issues with Urolithin A supplements on the platform.
Commenting on the new warning letter, which indicated FDA had tested the offending products, Dan Richard, vice president of global sales and marketing at NOW Health Group, told NutraIngredients-USA: "NOW has watched for FDA action against brands that fail badly in our testing protocol. Unfortunately, and despite NOW sharing our information directly with FDA for several years, we have not seen ANY action taken. This is shocking, unreasonable, and unexplainable. Why does the FDA take so long to enforce faulty supplements when given the testing results on a platter? We have no idea and have received no communication from FDA about our testing results.
Richard said that the FDA apparently first issued warning letters directly to the brands about seven different "so-called supplements" tainted with tadalafil in August 2023 and that some brands took corrective action to either reformulate or remove the product from the market. However, he expressed concern about why FDA waited four months to send a warning letter to Amazon given that it already had test results attesting to serious adulteration rather taking immediate action.
"It appears that cheating supplements brands, which are a small minority, will continue to cheat as long as they can get away with it," Richard added. "NOW is trying to work with FDA and major sellers like Amazon and Walmart to help police this problem. NOW really should not be doing this but only started when we noticed cheating brands were expanding and winning business. Our wish is for FDA and Amazon to take action to remove and recall the worst offenders quickly."
UNPA’s Israelsen echoed Richard’s sentiments, noting that the products that are badly failing to meet label potency claims cannot be "fixed by a loosely written certificate of analysis".
"This is intentional and the motive is profit," he said. "Amazon has dietary supplement quality requirements, please use them to rid the platform of profiteers who care nothing for the well-being of the consumer."
The FDA warning letter can be read HERE.
