FDA Finds Pure Powdered Caffeine to be Unsafe
In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. Every two weeks, we send out an email that gives a brief synopsis of enforcement actions in the dietary supplement space (we never share our subscription list, and you can opt out at any time at the bottom of each email). Staying apprised of enforcement trends in the industry, from FDA warning letters to FTC false advertising allegations, can help you to stay above the fray and off of the regulatory radar. Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
Here are the recent enforcement actions taken against purportedly non-compliant dietary supplement companies, and the claims made against them:
On September 1, FDA issued a Constituent Update stating its position on the dangers of pure powdered caffeine. FDA suggests that the difference between a safe amount and a toxic amount of these products is minimal, and nearly impossible to measure using ordinary kitchen tools. FDA reports that two young men in good health have died because of these products. At the time of the Constituent Update, FDA had already issued 5 warning letters to distributors of pure powered caffeine (see below)
On August 27, FDA sent five substantially similar warning letters to companies selling pure powdered caffeine. A representative example is FDA’s warning letter to Bridge City LLC regarding its caffeine products “Caffeine Anhydrous Natural Coffee Bean” and “Caffeine Powder (Synthetic Anhydrous).” Bridge City LLC’s website directed users to take “50 to 200 mg up to three times daily. Use an accurate milligram scale for measurement.” FDA reasoned: “This amount cannot be accurately measured using common household measuring tools. Many consumers do not have a scale that is sufficiently precise to accurately measure such a small amount.” FDA concludes that the products “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling” because “both products are packaged to contain an amount that would be lethal to many consumers; and the packaging requires the consumer to use a precise scale to separate out a safe serving from this lethal amount.”
On August 24, Novacare LLC, (“Novacare”) issued a voluntary nationwide recall of dietary supplements. Novacare is recalling numerous dietary supplements because sample analysis by FDA found that the products contained salicylic acid, which made the products unapproved new drugs. Salicylic acid is toxic and not recommended for oral use—in fact, it is often used as a wart remover. All of the products being recalled by Novacare are products that were directed by Novcare to be taken orally.
On August 27, the One Minute Miracle Inc. (“One Minute”) voluntarily recalled one lot each of its Miracle Diet 30 and Miracle Rock 48 products. Miracle 30 was found to contain undeclared phenolphthalein, an ingredient that was removed from the market because of concerns over carcinogenicity. Miracle Rock 48, which is marketed as a male enhancement pill, was found to contain undeclared thiosildenafil. Thiosildenafil is an analogue of sildenafil, which is an approved drug used for the treatment of male sexual enhancement. In addition to those products, One Minute chose to voluntarily withdraw from the market over 20 additional products “to provide its customers with the certainty of safety.” Although no concrete reason was provided for withdrawing these products, perhaps their names shed some light on the issue: “Miracle Cholesterol, Miracle Night Time, Miracle Joint-Flex, Miracle Stud 72, Miracle Magic Man, Male Mint Gum, Miracle 48 Hrs, Miracle Magic Woman, Miracle Cougar, Miracle Cougar Gum, Miracle Cougar G-Spot, Miracle G-Spot, Vagina Rejuvenation, Miracle Anti-Wrinkle, Miracle Stud Delay, Miracle Male Stud Spray, Miracle Male Stud Coffee, Miracle Male Coffee, Male 10, Miracle Male Stud Sublingual, Male 72 Hr, Miracle Tongue Sublingual, Miracle Tongue and Master Blaster.”
On July 22, FDA sent a lengthy warning letter to Westar Nutritional Corp. d/b/a Viva Life Science, Inc. (“Westar”) for selling unapproved new drugs/misbranded drugs. Westar listed on its website several scientific studies regarding its products and their positive effects on certain cancers. FDA reasoned that using such studies implies treatment or prevention of a disease and therefore the products were drugs and not dietary supplements. According to FDA, Westar’s drugs were misbranded because, among other things, they failed to bear adequate directions for their intended use(s) pursuant to 21 USC § 352 (f)(1). Additionally, FDA found that Westar failed to meet numerous current good manufacturing practices (“cGMP”), such as failing “to establish specifications for the identity of each component that [it] use[s] in the manufacture of [its] dietary supplement[s].” FDA stated that this and other cGMPs violations caused Westar’s dietary supplements to be adulterated.
In an August 24 press release it was announced that FTC was sending refund checks totaling $175,000 to consumers who bought allegedly deceptive products from NourishLife, LLC (“NourishLife”). NourishLife was selling products that claimed to develop and maintain normal, healthy speech and language capabilities in children. The $175,000 dollars was obtained in a settlement agreement with NourishLife. NourishLife also agreed to stop selling the allegedly deceptive products.
If you have a dietary supplement company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.