NHA asks court to find NLEA unconstitutional in lawsuit filed in New York.

NLEA DIETARY SUPPLEMENT HEALTH CLAIMS CHALLENGE ON FIRST AMENDMENT GROUNDS filed on June 30 by the Nutritional Health Alliance and New York supplement manufacturer and health food store New Nutrisserie in the U.S. District Court for the Southern District of New York. The suit, filed against FDA and HHS by New York law firm Bass & Ullman, charges that FDA preclearance of health claims for dietary supplements under the Nutrition Labeling & Education Act "constitutes a `prior restraint' of constitutionally protected speech."

The plaintiffs also asked the court to permanently enjoin FDA from enforcing the health claims provisions of NLEA and the implementing regulations for those sections because they would require prior authorization of health claims on dietary supplement labeling. The suit maintains that FDA's enforcement authority "as to which products make false or misleading claims would not be affected if the relief herein requested is granted."

The suit claims that the First Amendment gives the plaintiffs the right to "truthfully inform the public of the relationships between the consumption of dietary supplement products and disease- or health-related conditions."

Because health claims must be precleared by FDA under NLEA, the plaintiffs argue, the ability of dietary supplement firms to "provide the public with important health information has been severely delayed and prohibited." The suit mentions that FDA has, to date, approved "only two" health claims for supplements -- folic acid to prevent neural tube defects and calcium to prevent osteoporosis -- and "delayed" in approving both of them.

"The public should not be compelled to wait while FDA decides what the American public will be allowed to read about nutrition and their health and well-being," the suit declares. Truthful and nonmisleading information should be provided to the public "as quickly and efficiently as possible," the lawsuit says.

In addition, the plaintiffs contended that the public, which includes both "actual and potential consumers" of dietary supplements, has a First Amendment right to receive truthful and nonmisleading information on the health benefits available from the consumption of dietary supplement products as soon as this information is known." Limiting and delaying the availability of such information, the suit declares, is "not supported by a substantial government interest and [is] not tailored in such a way as to serve any government interest."

In a July 6 statement, NHA described the suit as "complementary" to the Food and Dietary Supplement Consumer Information Act (HR 1951), a bill introduced by Rep. Frank Pallone (D-N.J.) on June 28 to allow truthful and nonmisleading health claims on food and dietary supplement labels ("The Tan Sheet" July 3, p. 1).

HR 1951 would abolish the health claims commission established under the Dietary Supplement Health & Education Act, repeal the section on new dietary ingredients in DSHEA, and explicitly exempt supplements from consideration as drugs under the FD&C Act. NHA said Rep. Pallone and cosponsor Dennis Hastert (R-Ill.) are working on a "Dear Colleague" letter to gather more House cosponsors and to seek Senate supporters. A Senate companion measure has not yet been introduced.