[1]thx to alex-501 on flickr creative commons
A federal judge has tossed a lawsuit that alleged Bayer made bloated advertising claims for a product for preventing … drum roll… constipation, diarrhea, gas, and bloating. And the ruling may have broader implications for companies selling dietary supplements.
Here’s the back story: For the past seven years, Bayer widely advertised a product called Phillip’s Colon Health for preventing those gastrointestinal problems. The product is a probiotic supplement, which is derived from a proprietary blend of three bacteria.
But the US Department of Justice and the Federal Trade Commission believed the company made claims that lacked scientific evidence, and pointed to a 2007 consent decree [2]. This requires Bayer to back up any promotional claims with evidence. The decree stemmed from a case in which Bayer made unsubstantiated claims about its One-A-Day line of vitamins. The company paid a $3.2 million civil penalty to settle that case.
The Justice Department, which began probing the ads for Phillip’s Colon Health in 2011, argued that Bayer failed to substantiate claims, yet implied the elixir could prevent, cure, or treat symptoms of gastrointestinal discomfort. This, in turn, prompted consumers to spend hundreds of millions of dollars to purchase the product, according to the feds.
To assuage concerns, the feds maintained that Bayer should have conducted randomized, placebo-controlled clinical trials, according to their lawsuit [3]. The Justice Department dismissed as inadequate nearly 100 studies the company submitted to back its assertions. Nonetheless, the federal court judge hearing the case sided with Bayer, whose experts argued the company’s evidence was, in fact, sufficient.
Among the key points: the judge decided that a government expert failed to distinguish between the amount of substantiated evidence that is needed to compare a prescription drug and a dietary supplement. And as the FDA Law Blog notes, this distinction is necessary given that the FDA regulates supplements under a different set of regulations [4] than it does for prescription drugs.
“Congress enacted [the Dietary Supplementary Health and Education Act] to ensure that supplements can be marketed and sold without following the stringent requirements imposed on drugs,” US District Court Judge Jose Linares wrote in his 38-page opinion [5].
“Although new drugs must be pre-approved by the Food and Drug Administration, and traditionally must be supported by randomized, placebo-controlled, double-blind clinical trials, dietary supplements need not.” The opinion was issued late last month, but was only unsealed a few days ago.
The problem that the feds encountered was that the consent decree never explicitly required Bayer to provide such clinical trials as evidence to back any product claims. This meant the feds had to rely on one expert witness, who was unfamiliar with the framework of the law or Federal Trade Commission guidelines for substantiating claims for dietary supplements, according to the FDA Law Blog [6].
To what extent the ruling is a boost to supplement companies is unclear. For one thing, the government could issue an appeal. Meanwhile, the FTC could revise its rules that more clearly stipulate requirements for requiring evidence. And as the FDA Law Blog also points out, Bayer provided so much documentation to argue its case that other companies may find it daunting to do the same thing.
In any event, Bayer is quite pleased.
A Bayer spokesman sent us a statement saying “probiotic bacteria, including the three species used in [its product], have substantial science supporting their digestive benefits. Claims about [the product] are fully substantiated by numerous clinical, animal and genetic studies, among other things, and satisfy all applicable legal standards… Requiring a drug-level randomized controlled clinical trial for a dietary supplement is not and has never been the standard for dietary supplement claims.”