The latest top stories for the sports nutrition / dietary supplement industry:
FDA Enforcement
In a warning letter dated December 10, 2015, FDA warned Dherbs Health Emporium, Inc. for promoting its supplements for conditions that cause them to be misbranded and unapproved new drugs and for not following current Good Manufacturing Practices (cGMPs). FDA writes that the following claims, among others, cause the products to be drugs, because they establish that the products are intended for use in the cure, mitigation, treatment, or prevention of disease: “Works to minimize kidney stones”; “Works to reduce inflammation”; “[H]elp your body regulate and stabilize cholesterol levels”; and “[P]revent cardiovascular disease.” In isolation, some of the claims could arguably be considered proper structure/function claims, because they do not seem to suggest an effect on a disease-for instance, “[H]elping oxygen flow to the brain.” However, FDA appears to find they were disease claims in the context of their accompanying claims-e.g., “[R]epair . . . cerebrovascular system and brain” and”[P]reventing future strokes.” Moreover, FDA warns Dherbs Health Emporium for failing to comply with cGMPs, such as not establishing product specifications. FDA writes that the firm’s responses to the alleged violations, provided through the firm’s counsel, were inadequate. This letter highlights the importance of having experienced dietary supplement attorneys assist in responding to FDA’s inspectional observations. A more thorough response by lawyers familiar with cGMP requirements may have kept FDA from sending a warning letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm478819.htm
In a letter dated January 4, 2016, FDA warned Tibetan Herbal Balance, Inc. for selling unapproved and misbranded new drugs and for not following cGMPs. FDA writes that Tibetan Herbal Balance’s products are drugs because their intended use, established in part by testimonials on the firm’s website, is the prevention, mitigation, cure, or treatment of disease. For example, one testimonial reads: “My son with COPD was greatly improved with your Lung Support, no longer on OXYGEN. Thank you.” Further, FDA cites Tibetan Herbal Balance for cGMP violations, even though the firm does not manufacture its own products. FDA explains: “Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.” Own-label distributors beware: You are ultimately responsible for following cGMPs even though another entity manufactures your products.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm479816.htm
On January 6, FDA announced that U.S. Marshals (at FDA’s request) seized 90,000 bottles of dietary supplements labeled as containing the ingredient kratom. FDA writes that kratom, a botanical ingredient, could pose a risk to public health and carry the potential for abuse. FDA issued an import alert on the ingredient and products containing the ingredient last year. FDA exercised its administrative detention authority in this action, seizing over $400,000 worth of product. Under this authority, “FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.” In conjunction with this seizure, the Department of Justice filed a complaint alleging the firm’s kratom-containing supplements are adulterated because “kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.”
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480344.htm
CGMB in the News
Please check out CGMB associate David Torreblanca’s article on structure/function claims, available online via Natural Products INSIDER®, at http://www.naturalproductsinsider.com/articles/2016/01/constructing-a-proper-structure-function-claim.aspx.
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. We regularly send out emails giving a brief synopsis of the latest 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.
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.
We are pleased to announce that as of January 1, 2016, Bob McDonald is a New York State Supreme Court Justice and our firm will be renamed as Collins Gann McCloskey & Barry PLLC with the addition of two new partners. We look forward to continuing our service to you in the years ahead. Happy New Year!