Reprinted from Nutraceuticals International, Vol. 4, No 11, November 1999
The Nutraceutical Research & Education Act, first proposed in 1989 by Stephen DeFelice, chairman of the Foundation for Innovation in Medicine, and re-proposed in 2002, was finally introduced in the US Congress on October 1 by Representative Frank Pallone (Democrat, New Jersey). Dr DeFelice, a long-standing promoter of functional foods who coined the term “nutraceutical,” says the term encompasses foods, medical foods and dietary supplements, all of which are entities established under current federal laws and regulations.
The intent of the NREA is to encourage companies to conduct clinical research on their specific products in order to demonstrate whether they are effective and safe. The FIM believes that the NREA will accomplish two important objectives:
- it will rapidly increase medical discovery for the prevention and management of disease and other abnormal health conditions; and
- it will substantially decrease health care costs.
Dr DeFelice believes that the good (ie beneficial) products discovered as a result of the NREA will drive out the bad (ineffective) ones that are currently being marketed. Consumers spend $12 billion each year on dietary supplements and billions more on medical foods and related products, but “there are now far too many medical-health claims being made on products that are not supported by clinical research,” he says.
It is important that the industry transforms from being market-driven to being research-driven, he added. “Nutraceutical companies sponsor very little clinical research…and few realise that their present and future success requires that they start proving what they are claiming.” The NREA aims to stimulate this research effort via
- the creation of economic incentives and protection of individuals and companies who perform clinical research on their products to demonstrate their safety and efficacy; and
- the creation of a new avenue in food and drug law for nutraceuticals and functional foods, facilitating their consideration as genuine health care products.
Based on the Orphan Drug Act
The NREA (Bill HR 3001) is based on the key principle of the already-implemented Orphan Drug Act. Under the latter, if a company sponsors the clinical research on a product for a rare disease (affecting less than 200,000 people) and the clinical data are positive, then the US Food and Drug Administration will grant a seven-year period of marketing exclusivity to the company (NIs passim). Under the NREA, a similar exclusivity period (10 years), issued on the date of the approval of the petition, would be granted to a nutraceutical product which satisfied the requirements to carry an approved health claim, preventing other firms cashing in on “borrowed science.”
Rep Pallone, a member of the key House Commerce Subcommittee on Health and the Environment, agrees that the NREA will bring about medical-health benefits “whose potential is enormous to the American people.”
In a statement, he said: “several of my colleagues and I have been watching closely the developments in the nutraceutical arena. As one of the original primary cosponsors of the Dietary Supplement Health and Education Act, and as a member of the House Commerce Subcommittee on Health and the Environment, I have been following the debates of many people in government and in the private sector that the fundamental issue for these products is the lack of sufficient clinical research on them. Oftentimes, these products are difficult to, or are outright unable to, be patented. So there is a general lack of incentives to fully explore and develop the health potential of these products.”
According to Rep Pallone, “it is through basic science and clinical research that all of the safety and efficacy questions about these products will be answered3 and the public and industry can truly benefit.” He adds that “it is clear that more needs to be done in this area to create incentives to conduct clinical research and reward innovation.”
Dr DeFelice believes that the current regulatory framework for nutraceuticals, governed by the DSHEA and the Nutrition Labeling and Education Act, has led to an “epistemological chaos” in which there is considerable confusion and controversy over the definitions of health, disease, health claims and medical claims. The DSHEA and other current laws “mistakenly attempt to distinguish between a health and medical claim” and leads to situations in which a nutraceutical product cannot make a truthful claim on the label, eg that it lowers cholesterol. In the NREA, no distinction is made between a health or medical claim. “If a nutraceutical decreases insomnia, then the claim should reflect it,” he commented.
The NREA calls for a regulatory system within the FDA for reviewing health claims for nutraceuticals, on a case-by-case basis, “which is less burdensome than the traditional regulatory scheme for drugs.” The new scheme must reflect the fact that such products can safely prevent disease and health conditions, manage or improve health or reduce the risk of disease. This would entail the setting up of an Advisory Council on Nutraceuticals at the FDA, which would be responsible for evaluating the merit of each petition and decide whether it is in conflict with any other.
At the heart of the evidence required for approval would be at least one clinical trial which must show the beneficial relationship to a disease, health-related condition etc, while epidemiological or preclinical studies can be used in support of the application. The amount of evidence required to support the claim would differ depending on the case in question. There would also need to be evidence that the nutraceutical is safe for human consumption in the quantity and at the frequency required to provide the health benefit.
The entire draft text of the NREA and a separate commentary on its rationale can be found on the FIM website: www.fimdefelice.org
As the legislation is in the final drafting stages, Mr Pallone said he wanted to let people know that “we in Congress are committed to resolving the controversies remaining by empowering the private sector to do more and to be rewarded accordingly.” He added’ “we are committed to working with the FDA to make sure that it carries out Congressional mandates. Please feel free to share your thoughts with me or my staff on this issue and the legislation.”
FIM conference rescheduled
The FIM had scheduled a conference for early November to discuss the NREA, but introduction of the legislation came too late for this to be incorporated. Therefore, the planned meeting has been rescheduled for February 3-4, 2000, and will be held at the Waldorf-Astoria in New York City, USA. For further details and registration, please contact Patricia Park at the FIM office, 411 North Avenue East, Cranford, New Jersey 07016, USA. Phone: +1 908 272 2967; fax: +1 908 272 4583.