Speaking via videoconference at the Council for Responsible Nutrition (CRN) annual Conference in October, Daniel Fabricant, director, Division of Dietary Supplement Programs, ONLDS, CFSAN, noted more than 400 recalls of spiked products since 2008. The safety of dietary supplements is clearly a goal for the agency, as stated in its Foods and Veterinary (FVM) Strategic Plan (Goal 5). Specifically, one of the objectives is to “improve the safety of dietary supplement products and the supply chain.”
According to a statement from FDA Commissioner Margaret Hamburg, MD, “Manufacturers, distributors, importers and others in the supply chain of dietary supplements are responsible for ensuring that their products comply with the statutes and regulations FDA enforces…”
However, Mr. Fabricant said he saw a company at the SupplySide West tradeshow earlier in October that was selling steroids masqueraded as supplements. FDA also recently warned consumers not to use 20 weight loss supplements found to contain undeclared drugs. “In this day and age ignorance is no excuse,” Mr. Fabricant said of companies selling tainted products.
Recognizing the problem of adulteration, three leading non-profit organizations—the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP) and the University of Mississippi's National Center for Natural Products Research (NCNPR)—recently initiated a large-scale program to educate members of the herbal and dietary supplement industry about ingredient and product adulteration.
"There is a major problem in the global herb and dietary supplements industry in which there appears to be a persistent availability of adulterated herbs, herbal extracts, essential oils and other plant-derived dietary ingredients," said Mark Blumenthal, founder and executive director of ABC.
The ABC-AHP-NCNPR Botanical Adulterants Program aims to help protect consumers and responsible members of the herb and dietary supplement industry, as well as other manufacturers, by producing a series of detailed white papers, which will serve as an authoritative source of information on botanical adulterants with references to published official and unofficial analytical methods for companies and/or third-party laboratories to utilize to help detect the presence (or absence) of known adulterants.
When Steve Mister, CRN president and CEO asked Mr. Fabricant to discuss future enforcement actions that FDA might take to crack down on irresponsible companies in the dietary supplement industry, Mr. Fabricant hesitated to reveal specifics. However, he suggested the agency plans to do more than issue Warning Letters, saying, “We are going to do more than just hand out paper.”
Moreover, moving forward, it will be important to see what level of risk the agency places on the supplement industry. Future revisions to the Food Safety Modernization Act (FSMA), including Section 106 (Protection against intentional adulteration) could indicate if supplements are considered a “high risk” or “low risk” category. Alongside the New Dietary Ingredient (NDI) Notification draft guidance, Adverse Event Reporting (AER) and Good Manufacturing Practices (GMPs) the FDA will have plenty of opportunities to expose criminals.
But how does the industry get rid of illegitimate products and companies without stifling innovation and creating unnecessary burdens on responsible companies? That seems to be the $25 billion balancing act currently in question.
Behind the scenes, trade organizations like CRN are working diligently to advocate for this industry’s core principles, asking tough questions and supplying reasoned responses to government inquiry. That dialogue continues on a host of issues.
If you’re not already, get involved, be proactive and don’t let this industry get hijacked by the rogue predators who are looking to get rich on the cheap.
Sean Moloughney has been the Associate Editor of Nutraceuticals World since 2008. He can be reached at email@example.com.