FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements

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    Nov 15, 2012
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It is an understatement to say that the market for dietary supplements has been growing at a great pace. More appropriate words to use to denote this growth, which has been in terms of both the range of products and increase in number of people using them could perhaps be “phenomenal” and“explosive”.

A burgeoning market

The good news is that the market for dietary supplements grew in the region of 11 percent from 2009 to 2012. The better news is that it is expected to maintain the tempo over the next five years .This market is expected to touch a gargantuan size of $90 billion by 2015.

FDA looks weak, for once!

Ironically, despite such a rosy outlook,the dietary supplements market is largely unregulated, because the FDA does not have regulations for dietary supplements! It does have regulations, but these are subjective and nonbinding, and are nowhere near being as stringent as those for pharmaceuticals and medical devices. The main rationale for this position is that dietary supplements don’t go through the same scientific processes as pharmaceutical and related products at the time of manufacture.

No regulation, please

The FDA clearly states that it does not regulate dietary supplements. It states on its website:

“Dietary supplement manufacturers and distributors are not required to obtain approval from FDA before marketing dietary supplements. Before a firm markets a dietary supplement, the firm is responsible for ensuring that

·         the products it manufactures or distributes are safe

·         any claims made about the products are not false or misleading

·         the products comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations in all other respects”

Given this scenario; the market is also open to quite some manipulation, because this offers opportunities for bogus and unverifiable claims over the purported benefits of several dietary supplements.

Catch 22-situation for the FDA

So, what does the FDA do in such circumstances? It is caught in a quandary, because on the one hand, it is powerless because it does not regulate this industry; on the other, it cannot be silent when there are violations and excesses that cause harm to consumers, something it has to prevent.

The FDA has a relatively small role to play here. It cannot set stringent standards for these products. It works in tandem with the Federal Trade Commission (FTC) to ensure that manufacturers and distributors abide by the requirements for product labeling and carry out acceptable marketing claims. It offers recommendations to manufacturers and marketers of dietary supplements.

Guidance documents

The FDA is guided by two important guidance documents on this issue. These are "Dietary Supplements: An Advertising Guide For Industry" and "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act".

The first of these, “Dietary Supplements: An Advertising Guide For Industry" deals with identifying advertising claims and interpreting them. The second documentis about the FDA recommendations to a product that manufacturers have to substantiate a claim under section 403(r) (6) of the Act.

Be there to find out…

Do these sections solve the problem faced in this industry? Will the dietary supplements market continue to explode despite its non-regulatory nature? To find out, attend a webinar being organized by GlobalCompliancePanel, a leading provider of regulatory and compliance continuous professional education on November 20.

It will have Joy Frestedt, PhD, CCTI, RAC, FRAPS; President and CEO of Frestedt Incorporated, as its presenter. Dr. Frestedt heads a novel virtual Contract Research Organization network that has over 50 expertsand highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. She will offer valuable insights gained over 30 years of her experience in the industry to participants.

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