Appeals court reaffirms federal jurisdiction over and validity of structure/function claims

According to an analysis by the American Herbal Products Association, the ruling reaffirms federal jurisdiction over the regulation of claims made on dietary supplements​​. The original complaint, filed in the US Ninth Circuit Court, asserted that vitamin E supplements sold under NBTY’s brand Nature’s Bounty (also listed as a co-defendant) violated California’s Unfair Competition Law and several other state statutes. The lower court had rejected the plaintiff’s arguments in a summary judgement, and that decision was subsequently appealed.

Failure to prevent disease alleged as fraud

The argument, made on behalf of lead plaintiff Paul Dachauer, was that the products were fraudulent because they did not prevent cardiovascular disease. Dachauer argued that this was implied in the product’s claims that included language such as “support cardiovascular health,” “promote [] immune function,” “immune health,”​ and “circulatory health.”​

The Dietary Supplement Health and Education Act, the portion of federal law that specifically regulates dietary supplements, allows manufacturers to make general claims on their products that relate to structures or functions in the body, hence the structure/function label for these type of claims. “Promotes heart health”​ is a standard instance.  “Supports blood pressure within a healthy range”​ would be a more nuanced example.

Regardless of how the claim is worded, it must be supported by “competent and reliable scientific evidence”​ (a standard borrowed from the Federal Trade Commission) that the ingredients in a product have an effect on the structure or function of the body that is in question. Dietary supplements may not, of course, claim to diagnose, treat, cure or prevent any disease.

According to the appeals court, a compliant structure/function claim must, “[M]ust meet three requirements: (1) the manufacturer has substantiation that the statement is truthful and not misleading; (2) the statement contains a prominent disclaimer that the Food and Drug Administration (‘FDA’) has not evaluated the statement and that the product ‘is not intended to diagnose, treat, cure, or prevent any disease’; and (3) the statement itself does not ‘claim to diagnose, mitigate, treat, cure, or prevent” disease.’”​

Court: Distinction between disease, structure/function claims must stand

Prior to the filing of his original claim, Dachauer purchased one bottle of a Nature’s Bounty vitamin E product, and subsequently filed his suit. California’s consumer protection laws are written in such a way that actual harm is not necessary for the initiation of such an action (in other words, it is not necessary for Dachauer to have suffered from or have contracted cardiovascular disease to claim he was defrauded by the supplement’s inability to prevent it).

The appeals court noted the plaintiff’s expert witness, a physician, testified in the Ninth Circuit Court case that the products do not prevent or treat cardiovascular disease. The appeals court noted that the physician’s view was that, “[N]o metric ​except the absence or presence of cardiovascular disease can measure heart health (and, accordingly, no other metric can demonstrate whether a supplement promotes or supports heart health).”​

The appeals court ruled that the plaintiff’s argument sought in effect to erase the boundary between structure/function and disease claims.

“Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it,” ​the court ruled.

No claim for reducing mortality

Similarly, the plaintiff argued in the original case that the immune claims on the Nature’s Bounty vitamin E product were fraudulent because the product did not reduce all cause mortality. The Court found that plaintiff’s claim was preempted under federal law because manufacturers are not required to substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality.

Unfortunately, research from more than a decade ago​​ (since refuted by the industry​​) has linked high dose vitamin E supplements with increased mortality. This notion also formed part of Dachauer’s original argument. But even the expert witness in the original case admitted that there was only a small correlation between high dose vitamin E supplementation and an increased risk of death.

“Conceivably, evidence that a supplement endangered users by increasing their risk of death could prove that a structure/function claim that omitted the risk was misleading. But the record lacks evidence that vitamin E supplements are actually harmful, as opposed to simply useless at reducing all-cause mortality (which they do not claim to reduce),”​ the appeals court ruled.