In a recent enforcement action against a dietary supplement manufacturer James G. Cole Inc. (here), the FDA is seeking a Permanent Injunction based on repeated violations of cGMPs and distribution of unapproved drugs.  The unapproved drug issue relates to making drug claims for dietary supplements.  Making disease claims for dietary supplements is clearly a way to get yourself noticed by the Agency for the wrong reasons. 

This type of “health fraud” dates back to the days of the traveling medicine men in their covered wagons selling dangerous concoctions of different herbs and drugs and making all kinds of wild health claims for products like Doctor Feel Good Elixir.  The Pure Food and Drug Act of 1906 was really the first piece of legislation to address these unsafe products, although it placed the burden on the government to prove the products being distributed were unsafe.  At that time, before such a determination could be made, the medicine man packed up his wagon and moved to other parts of the country, but continued to sell their goods until the government caught up to them again and then repeated the move.

Over time, some unscrupulous firms have learned that the FDA is not always quick to act to remedy these violations, due primarily to a lack of resources to catch the bad guys.  Thus, many firms have learned if they can make a quick buck (or millions of quick bucks) ahead of any Agency enforcement action, they seem all too eager to skirt the law.

Almost weekly, FDA publishes a Health Alert or Warning advising of tainted “natural” dietary supplements for use to treat weight loss, erectile dysfunction, arthritis, diabetes, and for body building purposes (among other things).  These products are typically tainted with undeclared active pharmaceutical ingredients.  FDA has published alist containing only a small portion of the universe of tainted dietary supplements on its web page (here) and that list has 446 entries since 2007.  To me, this looks like a problem of epic proportions.

So what exactly is the problem?  Many of these products either contain harmful drug ingredients that can interact with other medications a patient is taking, or cause (in and of themselves) serious health consequences.  Making disease claims for “natural” and dietary supplement products may cause the patient suffering from an ailment to delay seeking proper medical treatment, the sequelae of which is obvious.

What can you do to protect yourself? Don’t be fooled by false claims. Be skeptical of natural products making claims, especially in the categories mentioned above.  Get advice from a medical professional.  When in doubt, contact the FDA.   If you are a manufacturer or distributor of dietary supplements, make certain you are obeying the law.

For further questions on cGMPs or regulatory advice on dietary supplements, please contact Roy Sturgeon Ph.D. ( or Joan Janulis (, respectively.