Regulatory Focus™ > News Articles > FDA Plans Meeting to Assess How to Enhance Safety Monitoring of Dietary Supplements

FDA Plans Meeting to Assess How to Enhance Safety Monitoring of Dietary Supplements

Posted 22 July 2013 | By Alexander Gaffney, RAC 

The safety of the pharmaceutical supply chain may be of perennial concern for regulators with the US Food and Drug Administration (FDA), but now dietary supplements are due to get some added scrutiny as well thanks to an upcoming meeting on chemical hazards.

Background

Unlike pharmaceuticals, dietary supplements are technically regulated more closely to food substances, avoiding the lengthy premarket approval process and the clinical trials required to generate substantial evidence of safety and effectiveness.

That food-like regulation is meant to reflect the substance of dietary supplements, which are a combination of vitamins, minerals, herbs, botanicals, amino acids, dietary substances, concentrates, metabolites, constituents or extracts.

Instead, the products are at most subject to a notification process for new dietary ingredients (NDIs) that only takes into account the safety of a given product.

When it comes to safety, however, FDA does treat supplements somewhat similarly to pharmaceutical products. For example, good manufacturing practice (GMP) regulations are relatively similar for both products, and adverse event reporting procedures are conceptually similar as well.

Finding Signals in the Noise

And, like drug products, FDA is concerned about the potential for unsafe and adulterated products to proliferate within the supply chain, potentially harming consumers.

According to a meeting notice published on 22 July 2013 in the Federal Register, FDA's Food Advisory Committee will soon meet to "discuss detection signals for noteworthy chemical hazards" in dietary supplements.

At issue is how FDA's Center for Food Safety and Applied Nutrition (CFSAN) "might recognize and best take advantage of those data," the notice added. In addition to supplements, FDA said the meeting would also focus on general food items and cosmetics.

The issue is not a new one for FDA. Testimony delivered in 1999 on an FDA Federal Register notice explained the heart of the problem: "A common public misconception is that substances are safe if they are natural, whereas they are likely to be hazardous if they are synthetically produced."

"Every chemical is toxic at some dose," continued two scientists with the Carcinogenic Potency Project at the University of California, Berkeley, Thomas Slone and Lois Swirsky Gold.

FDA's current meeting notice seems to take this premise at face value, instead focusing on the question of how the agency can detect such toxicities with greater ease. Because many dietary supplements are taken outside of medical settings (and hence away from experts), it can be difficult to detect when adverse events or toxicities occur.

A recent report by the Government Accountability Office (GAO) noted that FDA could stand to do a better job at utilizing the information it collects on adverse events for supplement products. The report found that FDA receives relatively few adverse event reports for supplements, but that it could nevertheless do a better job at leveraging the adverse event "noise" into signals and, ultimately, action.

The meeting will take place on 23-24 September 2013 at FDA's White Oak campus in Silver Spring, MD.


Federal Register Notice


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