Today, I participated in a special online chat session with the FDA. The theme was “Tainted Products Marketed as Dietary Supplements”, and I was fortunate enough to get my three questions answered by both the FDA’s Center of Food Safety and Applied Nutrition, Dr. Moore, and the FDA’s Principal Deputy Commissioner, Joshua Sharfstein, M.D.

What defines a “tainted product” in the dietary supplement industry?

Tainted products include ingredients that contain undeclared or deceptively labeled ingredients. The FDA has identified three common categories where tainted products tend to frequently emerge:

1. Weight loss products
2. Body-building products
3. Sexual enhancement products

While the FDA certainly doesn’t need my approval of these three categories, having over 11-years of experience in the dietary supplement industry I absolutely agree with their top three categories. It’s no coincidence that these three categories represent the top breeding grounds for corrupt individuals to make a fast buck at the expense of the consumer.

My questions answered by FDA representatives

(Me): The manufacturing and distribution of steroid-precursors continues to flood the Dietary Supplement industry despite FDA enforcement. Are these steroid-precursors legal, illegal or somewhere in between?

(FDA): We’re not aware of any of these steroids or steroid analogues that can remotely fit the legal definition of a dietary ingredient. So we think the ones that we’ve encountered are all illegal. As Dr. Sharfstein and others have commented why are there so many, there’s very low barriers to introducing new products into the country and they don’t have to come past FDA for preclearance, and so what you see is new products coming in and it becomes again an enforcement issue in trying to identify, locate them and take appropriate action. – Center of Food Safety and Applied Nutrition, Dr. Moore.

(Me): It is my understanding that Ephedra is now considered a controlled substance. However, there are still products being sold and marketed as containing Ephedra. Is Ephedra still legal, or are there variants of the Ephedra plant that are legal?

(FDA): In 2005 FDA banned Ephedrine Alkaloids from being marketed as dietary supplements. So you see some products out there that contain a species of ephedra some of which don’t contain ephedrine alkaloids or the firms have chemically processed the plant material to remove the ephedrine alkaloids and keep other substances that might be there. Those types of products are legal but there are products that can still contain ephedrine alkaloids that present many of the same problems as the tainted from an enforcement perspective these tainted supplements because they’re not approved it presents an enforcement challenge for us to locate them, some of them in the internet age may be off-shore very difficult to enforce. – Center of Food Safety and Applied Nutrition, Dr. Moore.

(Me): The criminals who are tainting dietary supplements might NOT be manufacturing these products in a cGMP compliant facility. Shouldn’t the FDA enforce that all United States-distributed dietary supplements be manufactured in an FDA compliant cGMP facility?

(FDA): I think that you’re pointing out one of the problems with these products. It’s not just that they may have a pharmaceutical in them, but they may be manufactured in a non-safe way. It is a big problem, and that’s one of the reasons why we’re taking these actions and focusing on this problem it’s because we are worried about poor manufacturing. – FDA, Principal Deputy Commissioner, Joshua Sharfstein, M.D..

What is the FDA doing to prevent tainted products in the dietary supplement industry?

In a letter sent on December 15, 2010 to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements.¹

These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.¹

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.¹

These tainted products can cause serious adverse effects, including strokes, organ failure, and death. The manufacturers selling these tainted products are operating outside the law. – FDA Commissioner Margaret A. Hamburg, M.D.¹

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg.¹

The agency also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.¹

My final thoughts about the FDA’s new enforcement strategy

Dietary supplements largely remain statistically safe and free of tainted ingredients. However, there’s always a con at every opportunity which has the potential to significantly disrupt and damage the reputation of the entire industry. The FDA’s online chat session allowed industry experts and affiliates to have their questions answered directly by key FDA representatives. The FDA needs to continue this partnership with industry experts and larger non-governmental non-profit compliancy organizations like the Natural Products Association to help combat the criminal element and to ensure better industry transparency.

I applaud the FDA in its efforts to help remove tainted products from the dietary supplement industry by collaborating with representatives from the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance.

Audio of FDA online chat for 12/20/2010

References

¹ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm236967.htm. Accessed on 12/15/2010.