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Finding a new path to market: regulatory agencies continue to come under fire, but is overhauling the FDA and FTC the way to go?

Over the last several months, there have been complaints lodged at the nutraceuticals industry revolving around recent actions taken by the FDA and FTC regarding product substantiation and the use of more aggressive disease-related claims. These grumblings are starting to become substantially louder as a small group of individuals continue their campaign to convince Congress to overhaul DSHEA by shifting the burden of proof to substantiate claims from the manufacturer to FDA and FTC. The goal of this movement seems to be more focused on stripping these two agencies of their authority rather than bringing some rationality to the regulation of products that are intended to help individuals with specific health conditions. This pie in the sky approach is not likely to yield anything beneficial to the industry, or consumers. Further, if the popular press gets wind of this development, it will only use this approach to hammer home the misconception that the natural products industry wants a free ride at the expense of the public. That said, it is time that the industry band together for real reform that will: (1) help alleviate the impression that the natural products industry is made up nothing more than charlatans; and (2) provide consumers with real information to help them make better healthcare choices.

Choosing a Sensible Channel for Products

Besides the traditional channels, there are alternative routes available for bringing products to market. One category much talked about but hardly utilized is medical foods. Much has been written in the past about medical foods, but this category is ill-defined and, at least in FDA's mind, requires that a company show that a particular medical food actually provides nutritional management of disease that cannot be achieved through diet alone. This position is spurious at best. Under FDA's rationale, a company cannot develop a medical food for type 2 diabetes or "Syndrome X" because medical wisdom indicates that both of these conditions can be treated by diet modification alone and that diabetics do not have a special need for a specific food. Yet we know that adding specifically designed high fiber diets to a type 2 diabetic's diet could help them manage their disease without drugs. Thus, it makes no sense that FDA would have an issue with such a medical food. Unfortunately, however, it does.

Another potential category of products that is often overlooked is homeopathic drugs. In simple terms, this category of drugs starts with the idea that "like treats like." For example, a highly diluted tincture of poison ivy can help treat oral herpes. With the exception of a few popular homeopathic products for colds and allergies, they have yet to reach critical mass in the market.

Another option is the use of third party literature in an attempt to inform the general public that a particular product may be helpful in the treatment of a disease. But third party literature has a major drawback: it cannot promote a particular brand of supplement, nor can it be attached to the product label.

A less desirable possibility is to go through the rigorous drug approval process. Besides the fact that this will cost a company a significant amount of money, it will only achieve limited exclusivity if the ingredient is not patented. Furthermore, exclusivity will only keep similar products from being marketed as a drug, but products marketed as dietary supple-ments will have no restrictions in this regard. There are also significant scientific barriers. Specifically, a company going through the drug approval process will have the added task of identifying the main actives in the product, and it will have to guarantee the safety and effectiveness of a product from batch to batch and lot to lot. Those of you who understand the science behind this also understand how difficult this process would be for a natural product.

Change FDA and FTC Responsibilities?

So why not gut the FDA and FTC and rearrange their regulatory authority? The problem is, changing the responsibilities of the two agencies is not practical. However, there is a procedure that has been used successfully in other countries and Canada that may bode well for this industry.

This new system could be as simple as designing an over-the-counter (OTC) natural drug products monograph, or requiring that a company submit its formula and substantiation file to FDA for review. The latter is not very workable, initially. The former, however, is feasible.

To start, a list could be developed for those widely used herbal products that have been used in countries, such as Germany, to establish natural product monographs in this country. These products will be available OTC and would not be intended to treat serious disease conditions, such as cancer or AIDS. However, through proper labeling a product could be marketed as a natural treatment for individuals with Syndrome X, or for diabetics that do not require medication.

To keep the system current, an approval process for novel natural ingredients could also be developed. It would not be as demanding as FDA's new drug process, but it would require a degree of scientific validation to get these novel ingredients into the market. To encourage innovation, limited ex-clusivity should be provided for these products. As an example, for those products/ingredients not covered by a patent, granting a company 60 months of exclusivity would be logical. This should help the company recoup some of its costs and earn a profit before facing competition.

Another aspect of this system is that as long as the claims are consistent with the natural product monograph, the FTC cannot request the company to provide scientific substantiation for the claims unless the maker of the claim states that it has clinical studies to back up its claims or the claims are clearly outside the monograph.

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004; 202-344-4724; E-mail:
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Article Details
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Author:Harrison, Todd
Publication:Nutraceuticals World
Geographic Code:1USA
Date:Nov 1, 2005
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