DSHEA and NREA: Perfect Together?

Even with the regulatory guidance of DSHEA, the supplement industry remains full of ambiguity. The NREA aims to close loopholes and boost consumer confidence.

By
Joanna Cosgrove
Online Editor

Prior to the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), fraudulent dietary supplement products and claims filled the market, much to the industry’s detriment. Flash forward 13 years and it seems the industry is still trying to shake the “snake oil” stigma. Why? Some say it’s because DSHEA, although well-intentioned, is too broad, with too many loopholes.

Prior to DSHEA, Stephen DeFelice, MD, founder and chairman of the Cranford, NJ-based Foundation for Innovation in Medicine (FIM) nonprofit organization, crafted a legislative proposal dubbed The Nutraceutical Research and Education Act (NREA) in an effort to help regulate the then unregulated dietary supplement industry. The core principle of NREA is to offer economic incentives for companies to sponsor clinical research or studies on their specific nutraceutical products.

Dr. DeFelice’s interest in the NREA was based on his long relationship with carnitine and his appreciation of The Orphan Drug Act, which encourages companies to invest in clinical research by essentially granting them exclusive seven-year rights to make a disease claim based on the results of the clinical studies. It also reduces the amount of clinical data and total cost required to obtain FDA drug approval.

“Although (carnitine) has broad medical potential, no pharmaceutical company was interested in it because it lacked a strong patent,” he recalled. “Then the Orphan Drug Act came along, which granted a company seven years exclusivity to make the claim on rare diseases. Because of this, carnitine was approved by the FDA for the rare disease of carnitine deficiency. The act was a success. Since carnitine was also found in the health food stores, I concluded that the NREA, based on the Orphan Drug Act, would lead companies to sponsor the development on nutraceuticals—foods and health foods.”

The NREA defines a “nutraceutical” as “a food or part of a food that has a health benefit including the prevention and treatment of disease,” and includes dietary supplements, foods and functional foods.

In 1999, the NREA was introduced to Congress by U.S. Rep. Frank Pallone, Jr. (D-NJ), who has a long and particular interest in nutraceuticals, but it never received the support it needed to pass. But there is renewed hope for the NREA now that Mr. Pallone is the head of the Energy and Commerce Committee on Health.

NREA Nuts & Bolts

The FIM NREA proposal is based on the same principles of the Orphan Drug Act. If a company sponsors clinical studies on its product and FDA approves it, that company will have a seven-year claims exclusivity period. In January, Dr. DeFelice wrote an open letter to Mr. Pallone urging him to revisit DSHEA and reconsider the tenets of the NREA.

In his letter, Dr. DeFelice adeptly conveyed the frustrations of the dietary supplement consumer who turns to supplements to “get rid of their diseases, if they have them, or to prevent them if they don’t.” When it comes time to decide which supplement best suits their needs, he said there are three objectives that consumers need met to feel confident in their supplement decision-making process:

•Are the dietary supplements effective for the reasons consumed?
•Are they acceptably safe?
•And is the information available to them truthful?

In the vein of responding to those three nutraceutical objectives, Dr. DeFelice calls for concrete clinical studies to be conducted on dietary supplement products. “We can only know that penicillin works against bacterial lobar pneumonia; that insulin reverses diabetic coma; that niacin lowers blood lipids and that cranberry juice reduces the severity of urinary tract infections in women—and that all are acceptably safe—from data generated by clinical studies.”

Conversely, he argued, DSHEA does just the opposite. He says DSHEA was designed to accommodate a variety of players and discourages clinical research, resulting in confusion about supplement effectiveness and safety. Furthermore, he adds that the burden of carrying out DSHEA’s tenets is far too much for the FDA to manage. “The NREA presents a new business opportunity open to food, health food and the ethical OTC pharmaceutical market,” commented Dr. DeFelice. “The consumer demands to know about the effectiveness and safety of these products. The NREA will bring these three health sectors together to conduct clinical research on their specific nutraceutical products, making them competitive.”

The cumulative result of this lack of solid clinical work, he said, presents itself in the gray and restrictive area regarding health claims, and thus the proliferation of misunderstood or fraudulent products. “What company would make a substantial investment to sponsor clinical studies on its products when it is not allowed to educate the public, let alone physicians and other health care professionals, about the truth, but instead, it is pushed into making misleading and/or confusing claims?” he asks. “The company will, instead, like water, take the path of least resistance to the marketplace.”

Moving Forward

Dr. DeFelice predicts that the NREA’s impact on the future nutraceuticals industry will be to divide the category into two general sectors similar to the ethical and generic pharmaceutical industries, but with important differences. “The former, similar to the NREA industry, because of the exclusivity given to the claim, develops proprietary, high profit margin products that generate sufficient funds to sponsor clinical research, while the latter, similar to the DSHEA industry, is a commodity, nonproprietary industry with low profit margins and therefore little incentive to invest in clinical research,” he said.

But can DSHEA and the NREA coexist? At first blush, the answer is yes. “The NREA is the right idea and addresses the right problem of how to offer greater incentives for innovation and development of ‘nutraceuticals,’” said Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT. “The NREA or analogues are not intended to replace DSHEA, but to ‘weld on’ a missing element that deals with economic and research issues.”

Industry attorney Scott Bass, a partner with the Washington, DC-based law firm Sidley Austin Brown & Wood LLP, was instrumental in drafting DSHEA. Although he doesn’t believe the NREA will replace DSHEA, he acknowledged that the industry is in the early stages of making some sort of transition. “This legislation is a beginning, but in this Congress unlikely to move strongly this year,” he said. “Functional foods are a major issue now, and FDA’s December hearing signals an interest in cleaving this category from conventional foods and dietary supplements.”

Mr. Israelsen believes the NREA has a lot of merit when it comes to moving the dietary supplement industry forward. “Dr. Stephen DeFelice…recognized early on that the basic rules of economics apply to our industry as to all others…no one invests where a reasonable return cannot be justified,” he said. “I would welcome the political support of Mr. Pallone to sponsor the NREA or similar legislation that seeks to address this problem. The political landscape remains a challenge, as Mr. Pallone will have to work with Reps. John Dingle (D-MI) and Henry Waxman (D-CA), who also intend to address the issue of dietary supplements, but from the opposite direction—by holding hearings to address real or perceived misbehavior by dietary supplement companies.”

While Mr. Pallone was unavailable for comment regarding his stance on reintroducing the NREA to Congress, Dr. DeFelice said he continues to reach out to him for his support. “I am in the process of forming a Nutraceutical Advisory Group (NAG) with representatives from all three aforementioned sectors in order to harmonize their input into a single document,” he said. “It will take decades to conduct clinical research on a limited number of nutraceuticals and obtain approval. DSHEA can stand alone as it is and the NREA should not be a modification of DSHEA for it would involve too many parties with multiple and diverse interests to get the job done.”