A little more than a year ago, I gave a presentation on FDA hot topics. One of the areas that was identified in my presentation was a potential for an increase in FDA enforcement efforts relative to dietary supplements, their claims, and the issues of new drug claims. I stumbled across a posting on the FDA webpage that gave examples of dietary supplement Warning Letters that were identified by FDA under the general classification of “Health Fraud”.
The posting (here) listed 60 Warning Letters and, at the end of the posting, FDA defined their view of the health fraud classification as follows:
“The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.”
The 60 letters, all issued in 2015, were divided into 7 general categories:
|Category||Number of Letters|
|Unapproved New Drug||25|
|New Drug Labeling/Misbranded||10|
|New Dietary Ingredient-No Required Pre-notice||12|
|Homeopathic Drug with Health Claims||1|
|Unapproved Food Additive||1|
|Unapproved New Animal Drug||2|
While some of the categories appear to be overlapping, the message is that the FDA is ramping up its enforcement in the area of dietary supplements.
With questions swirling around relative to the efficacy of some dietary supplements and the increase in the introduction of products marketed as dietary supplements with undeclared drugs, how long will it be before the FDA really clamps down on this segment of the industry? Some players are giving dietary supplements a bad rap. But, as a whole, this industry segment has operated somewhat like the Wild West for quite some time. As the political climate changes and as people become more health conscious, the public may demand more oversight for the dietary supplement industry. The phrase “first do no harm” may be applied when one sees the plethora of Warning Letters citing unsubstantiated claims, questionable efficacy, misbranding, and adulteration. Remember – those 60 letters represent only a fraction of the products that the FDA has identified as violative. Remember the Unapproved Drug Initiative of 2006 and its success over the ensuing 7 years where FDA removed over half of the estimated 3500 unapproved marketed prescription drug products from the market?
Could dietary supplements be the FDA’s new target? Will changes be made in the dietary supplement program or will new regulations and requirements be forthcoming? Remember that the FDA is now looking hard at homeopathic products. Will they also catch dietary supplements out of the corner of their eye? Only time will tell, but that’s where my money is laid.