Pharmaceutical and Medical Packaging News
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Originally Published December 1999
REGULATORY FOCUS
Disease Claims for Nutraceuticals
A bill in the House would protect petitioners' disease claims for 10 years.
"Who in his right mind would spend millions to prove the benefits of a plant no one can patent?" asks James A. Duke, PhD, author of the book The Green Pharmacy. Duke isn't the only one who doubts the possibility of clinical trials for supplements. Even though a successful clinical trial could enable a nutritional supplement marketer to make disease claims on its labeling, no firm wants to pay to conduct a study that could also benefit its competitors.
However, Representative Frank Pallone Jr. (D–NJ) believes he has found a way to encourage such studies. Sponsor of the Nutraceutical Research and Education Act of 1999, HR 3001, Pallone seeks to provide economic incentives and protection of individuals and companies who perform nutritional supplement clinical research. The bill was introduced October 1, 1999.
The Act has four purposes:
- To promote research into the health benefits of dietary supplements, medical foods, and other foods.
- To establish a simplified process within FDA for reviewing, on a case-by-case method, claims of health benefits of such nutraceutical products made under petition under Section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S. Code 343(r)(3)).
- To prescribe a period of exclusive marketing protection for a person who demonstrates the health benefits of a dietary supplement, medical food, or other food, and who markets such product in association with approved labeling that describes its contribution to human health.
- To confirm the health benefits of these products as determined by clinical trials and to disseminate this information to the public and the healthcare profession, so that the public and the healthcare profession may integrate this knowledge into practice.
Petitions must include the following:
- A report of at least one clinical trial that has been conducted on the product subject of the petition. Such clinical trial results shall address the potential health benefits of the product and its safety.
- Evidence that it is safe for human consumption in such quantity and with such frequency as required to provide the health benefits.
- A complete description in the case of a processed product as to its ingredients or chemical composition.
- Information adequate to determine, where pertinent, that the methods used in and the facilities and controls used for processing and packing the product are sufficient to preserve its identity, strength, quality, and purity.
- Samples of the product.
- A specimen of the labeling proposed to be used with the product, when introduced or delivered for introduction into commerce as a nutraceutical, that accurately and completely describes its health benefits under its stated conditions of use.
Under the Act, within seven days of receiving the petition, an authorized secretary will publish a notice in the Federal Register. No other petition for a product or for a claim that is the same as or similar to the product or claim for which a petition has been filed may be filed until final action has been taken on the first petition. If the secretary issues a regulation in response to a petition relating to a claim for a nutraceutical, the secretary may not issue another regulation for an essentially identical nutraceutical claim during the 10-year period that begins on the date that the original petition is approved.
There are two exceptions to such 10-year exclusivity. If a petition is submitted for an essentially identical nutra- ceutical claim for a nutraceutical the intended use of which provides greater effectiveness, greater safety, or otherwise a major contribution to patient care, the secretary may issue a regulation for such a claim. If a petition is revoked, another petition may be submitted to the secretary for an essentially identical nutraceutical claim.
The Act also establishes within FDA an Advisory Council on Nutraceuticals. The council shall evaluate the merit of each petition, including the proposed labeling, and submit its evaluation to the secretary. The evaluation will determine whether a petition is worthy for FDA review.
Finally, the Act makes it lawful under antitrust laws for two or more small businesses to agree to combine their resources to meet the requirements for health benefit claims of a nutraceutical.
At Interphex West 99 in Long Beach, CA, attorney Antonio C. Martinez, who presented the bill to attendees at a day-long nutraceutical conference, stressed the need for clinical research on nutritionals. Attendees, however, had some concerns about the bill. "The bill would create a monopoly," said one attendee. "Anytime there is no competition, prices will go up."
Martinez replied, "Anytime a company prices its products so far out of the marketplace, it will lose market share. There will still be competition from generic products. And companies may have to prove that their products are clinically superior to new products. There has to be an incentive for clinical research. This bill isn't the only solution, but it is one solution. The status quo is not acceptable."
For more information, contact Representative Pallone at his Washington, DC, office at 202/225-4671.
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