FDA won Pyrrhic victory over scientific literature, say plaintiffs

American Longevity and its founder Dr Joel Wallach filed a complaint with the US District Court for the Southern District of California on 3 February 2004 alleging that section 21 USC 342-2a of DSHEA, which prohibits the dissemination of scientific literature containing health and drug claims even if it is exempt under the FDA's statute for intended use, contravenes the first amendment to the Constitution.

The section meant that the direct marketing company was prohibited from sending the Physician Desk Reference (PDR) relating to magnesium to its distributors along with a list of products and prices - a limitation it said curtailed its right to freedom of speech.

American Longevity had wanted to send distributors the literature, which contains information about magnesium's applications in both supplements and drugs, so that they could advise consumers under what circumstances it is appropriate to take the mineral as a supplement and when they should consult a physician.

"It was an end to which the government should have been pleased,"​ Jonathan Emord, counsel for American Longevity and Dr Wallach told NutraIngredients-USA.com.

But however well intended, the FDA considered that sending the package of material to distributors would constitute a violation of its policy on intended use - that is, the classification of a product as a dietary supplement, conventional food, or drug based on its intended use and governed largely by the material supplied on the label or in accompanying literature.

The court accepted that scientific literature in question is not inherently misleading, and said that any restriction on its dissemination must be evaluated under all four parts of the test for evaluating commercial speech, as established in a 1980 court case known as Central Hudson Gas and Electric.

In applying this test, the court concluded that the FDA's intended use statute is, indeed, constitutional.

"On the one hand it grants the government a Pyrrhic victory in that the injunction is denied, but also it interprets the statute in a way that the government did not intend,"​ said Emord.

In denying the plaintiffs' motion for summary judgment, the court maintained they did have the standing to sue to invalidate the statute for intended use but accepted the FDA's argument that they did not have standing to sue to invalidate the enforcement policy.

However it accepted American Longevity's argument that the FDA cannot use its intended use policy to block dissemination of scientific literature containing health claims and drug claims in situations where the statutory exemption is satisfied.

"The government lost the argument but won its case,"​ added Emord.

But the FDA doesn't see it that way. A spokesperson told NutraIngredients-USA.com: "In FDA's view, the court's decision was favorable to the agency's position."​

Nonetheless, Emord says the outcome of the lawsuit is important for the supplements industry as a whole, since until now the government has been able to take an unequivocal position on the dissemination of third party literature.

"On balance, we didn't get the injunction but we got a substantive outcome we find pleasing."​

He said that the company believes it could disseminate the PDR section on magnesium that gives a balanced view of the evidence without the product and price information.

It has asked the Justice Department to confirm whether this would be permitted and has requested a response by 8 April.

Anerican Longevity also plans to file an appeal against last week's decision with the US Court of Appeals for the Ninth Circuit.