Congress Set to Consider Nutraceutical Research and Education Act
Published: Monday, November 01, 1999
The legislation stands to shift the direction of regulatory policy for dietary supplements and foods by providing for market-based incentives and claims exclusivity for conducting clinical research on products.
The legislation was the initial inspiration of the NJ-based Nutraceutical Alliance and Foundation for Innovation in Medicine Chairman Stephen DeFelice, M.D.
In his statement on the House floor, Congressman Pallone reiterated the key reasons for the legislation: “The time has come for Congress to step forward and encourage a research-based dietary supplement and functional food industry. … [T]he answer is a public-private partnership to get these products researched,” he said.
The legislation establishes a legal definition for nutraceuticals and allows companies that conduct research on their products to obtain market exclusivity after applying for it to the FDA. Claims allowed would go beyond the structure/function limitations of the 1994 Dietary Supplement Health and Education Act (DSHEA). NREA-approved claims would include claims on how a product can prevent disease, reduce or eliminate a known risk factor for disease, and/or help manage a disease state.
Under the proposed legislation, these claims would be exclusive to the holder for a period of 10 years. To encourage better products, a clinically proven superior product could supplant that of an earlier nutraceutical claim holder. To encourage small businesses to pool their resources and conduct research together, an antitrust exemption provision is also included in the bill.
The natural products industry has been enjoying stellar growth since the passage of DSHEA.
Indeed, Pallone was one of the original sponsors of DSHEA and went to great lengths to ensure that DSHEA would not be amended by the NREA. However, signs that the industry is peaking have surfaced, perhaps slowed by market saturation of products and the effect of confusion over health claims in the marketplace.
Anticipating the next chapter of legislative debate and reform on dietary supplements, Pallone felt it was important to set a road map for discussion on what to do next with natural products. On the floor of the House, he said: “Congress must, Mr. Speaker, in my opinion, as a matter of public policy, encourage the scientific and clinical study of dietary supplements and functional foods ... [M]uch still needs to be done. Many individuals and companies that would like to clinically research their products have encountered numerous barriers along the way. …”
With the 2000 congressional elections on the horizon, the industry will face up to the fact that legislative reform on dietary supplements and food regulation is inevitable.
Congressmen Henry Waxman, D-CA, and John Dingell, D-MI, have both stated their intention to seek repeal of DSHEA if the Democrats regain the House majority. The favorable hearings the industry has enjoyed under Congressman Dan Burton, R-IN, would cease. Further, market conditions are such that additional reforms and modifications to food and drug law will be necessary.
The next phase of the dietary supplements and functional foods regulation debate will see the entrance of health insurance companies that are looking for legitimate and rational ways to provide coverage. In addition, health professionals are using supplements and functional foods in greater numbers, and two subsets of the consumer market—patients and people with health risks—will be looking to purchase high-quality, clinically tested products with verifiable claims.
Industry reaction to the bill has been moderate, with trade associations holding internal discussions as to whether to support the legislation. The reality is that a new phase of legislative reform and regulation is on the horizon. The NREA seeks to reward science and quality products—goals all parties would hope to achieve in public policy.
Antonio C. Martinez II, Esq., a government-relations specialist on health care and food and drug law, is principal of the law firm that carries his name and serves clients through offices in NJ, NY and Washington. For copies of the NREA legislation and floor statements, e-mail tonymartinez@compuserve.com.