As rates of U.S. consumers with diabetes or suffering pain or inflammation increase, so does the number of products labeled as dietary supplements that FDA is finding tainted with prescription ingredients used for those conditions, according to the director of the Center for Food Safety and Applied Nutrition.

The majority of spiked supplements remain concentrated in the sexual enhancement, weight loss and body building categories, but “we are now seeing some in the areas of pain management and diabetes,” FDA food chief Michael Landa told industry leaders Oct. 4 at the Council for Responsible Nutrition’s Conference in Laguna Beach, Calif.

Landa said the categories offer significant growth potential and likely are drawing attention from noncompliant firms selling illegal products as well as responsible supplement manufacturers that are developing and offering products within the legal boundaries.

Data presented at the conference show the potential market for supplements making claims for treating or preventing diabetes is growing rapidly. The percentage of U.S. consumers with diabetes rose from 30% in 2003 to 34% in 2011, said Mary Molyneaux, president of the Natural Marketing Institute.

Molyneaux added approximately 25 million U.S. consumers have diabetes, and 79 million U.S. consumers are estimated to have pre-diabetes, which means the category and disease likely will continue to skyrocket.

As a direct extension, more consumers want help balancing blood sugar levels, Molyneaux added. In 2012, 33% of the general U.S. population said they wanted these ingredients compared to 26% in 2005, she noted.

The agency is enforcing against supplements that make illegal drug claims related to diabetes, including Naturavit Inc., which received a warning letter in late August for Noni Imperial Hawaiian, and Alfa Vitamins Laboratories Inc., which FDA warned in July for promising diabetes relief from products including Alfa’s Sugar Control/Blood Sugar, Diabetifen and others ([A#05120924015]and Also see "Regulatory News In Brief" - Pink Sheet, 3 September, 2012.).

Likewise, “the aging population is exploding,” and with age comes chronic and new pain associated with deteriorating bodies, Molyneaux said.

Beyond tainted supplements, FDA is scrutinizing an uptick in supplement claims related to prevention of sexually transmitted diseases and concussions.

– CFSAN head Michael Landa

To help enforce against tainted supplements, Landa asked industry stakeholders to help FDA root out and stop manufacturers and distributors of tainted supplements. He encouraged firms to send leads to FDA through the agency’s district offices, an anonymous tip line run by the Office of Criminal Investigations or even through unsigned letters to CFSAN or the Center for Drug Evaluation and Research.

Landa advised conference attendees to watch for other red flags that could signal a product is spiked. These include claims the product works like or better than a prescription drug; label contraindications or warnings for pregnancy, cardiovascular disease or seizures; and labels in a foreign language or broken English.

Similarly, directions to take a product an hour and 15 minutes before sexual activity may indicate adulteration with an erectile dysfunction drug, while instructions to take one in the morning before breakfast may appear on a spiked weight-loss product.

“These flags don’t mean in and of themselves that there is a problem, but they are the kinds of things we look for because in the course of dealing with this problem, at the time, we have seen that they are indicators” of tainted supplements, Landa added.

STD, Concussion-prevention Claims

Beyond tainted supplements, FDA is scrutinizing an uptick in supplement claims related to prevention of sexually transmitted diseases and concussions, Landa said.

For example, the agency sent warning letters in August to PruTect Rx for claims NeuroPruTect protects against concussion damage and to Trinity Sports Group Inc. for promoting Neuro Impact Concussion Response Formula for treating concussions Also see "In Brief" - Pink Sheet, 10 September, 2012..

FDA sent 12 letters to firms making online STD treatment claims for OTC drugs and nutritional products in May 2011 Also see "FDA Expects STD Claims Enforcement To Deter Future Violations" - Pink Sheet, 9 May, 2011..

When looking at products that make these claims, FDA first asks whether the product can harm users, regardless of the claim, and second, whether the product itself is harmless if the claim could cause harm by leading consumers to forgo treatment, Landa said.

Spiked “Supplements” For Diabetes, Pain On The Rise

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