U.S. FDA Set to Increase Enforcement on Dietary Supplements
Office of Dietary Supplement Program set to increase industry oversight and consumer protection in light of high profile violations
08 March 2016
With over half of Americans taking some variety of dietary supplements daily, it is not surprising that annual sales of dietary supplements have burgeoned into a 35-billion-dollar industry. However, over the last year, the supplement industry has suffered from several media-related “black eyes”. Those following the industry will recall New York State’s Attorney General using an improper testing method to call out herbal supplement manufacturers, which raised an unjustified maelstrom about ingredient identities. More recently, “exposes” by CBC Marketplace (which ended up having to publish a retraction due to inaccurate testing results they used) and PBS Frontline questioning the quality and regulation of supplements have added to consumer confusion.
For many years now there has been a call for the Food and Drug Administration (FDA), the government agency responsible for oversight of the supplement industry, to pay closer attention to dietary supplements on the market and to allocate more resources to support its enforcement efforts. In light of this, in December 2015, the Office of Dietary Supplement Programs (ODSP) was created. The ODSP, previously a division of the FDA’s Office of Nutrition Labeling and Dietary Supplements, will be responsible for monitoring the safety of dietary supplements and will take actions against companies whose products pose a potential risk to consumers. This elevated status will allow the ODSP to obtain more funding and increase the effectiveness for enforcement of the rules set out by the Dietary Supplement Health and Education Act (DSHEA).
The ODSP will focus primarily on the enforcement of the dietary supplement good manufacturing practices (GMP) regulation, taking actions against claims in cases involving serious risk of harm to the consumer. In addition, the ODSP will work with FDA’s Center for Drug Evaluation and Research to help remove from the market falsely labeled dietary supplements that contain pharmaceutical ingredients, such as steroids or ingredients approved as drugs for the treatment of weight loss or erectile dysfunction.
It is the responsibility of supplement manufacturers to ensure the safety and regulatory compliance of their products and the vast majority of industry players provide safe and compliant products. Even so, in the past few months alone, FDA has issued numerous warning letters to dietary supplement companies for misbranding, undeclared and adulterated ingredients, incorrect levels of ingredients, and for marketing unapproved new drugs. Although these issues may not always be the result of “bad actors” in the industry these violations have the potential to put consumers at risk of serious adverse reactions and drug interactions. Even for companies that are careful, these types of violations can prove costly both financially due to the cost of recalls, lost sales revenue, and potential legal fees but also the cost of lost consumer confidence.
Dietary supplement manufacturers will be looking to bolster consumer confidence in their products while the ODSP will be setting its sights on the non-compliant ones on the market. Quality assurance and product regulatory compliance can be a challenging and complex process. But investment by manufacturers in these areas will help those brands withstand further forays by prodding Attorneys General and those seeking to exploit the negative press brought on by non-compliant companies.
Intertek staff has extensive experience in the evaluation dietary supplement safety and claims, and have an excellent approval record in the preparation and submission of New Dietary Ingredient Notifications (NDINs) to the FDA. It is also part of an extensive network of testing labs to support ingredient and product quality assurance.
Today's expert blogger, Monica Kumar, is a scientific and regulatory associate with experience in preparing safety evaluations for food ingredients/additives, dietary supplement ingredients, and cosmetic ingredients. She has compiled assessments as parts of dossiers for submission to the regulatory bodies in the United States and the European Union. Her familiarity with the regulatory requirements for substantiating safety in each product category makes her an asset to the Intertek Scientific & Regulatory Consultancy team.