The Government did not appeal the ruling of U.S. District Court for the District of New Jersey refusing to hold Bayer AG in contempt for the alleged failure to substantiate structure/function claims made for its probiotic supplement marketed to promote digestion.
A 2007 consent order required Bayer to possess "competent and reliable scientific evidence" for all dietary supplement claims. Bayer's product packaging and advertising states that Phillips' Colon Health (PCH) probiotic supplement "Helps Defend Against Occasional Constipation, Diarrhea, Gas and Bloating." When the government began investigating the claims, Bayer submitted 100 scientific papers as evidence of substantiation. It also had evidence of a robust internal process to substantiate claims.
The government based its case not on the DSHEA or regulatory guidance documents, but on the opinion of one doctor, Dr. Laine, who opined that the only way for Bayer to substantiate its PCH claims - or any structure/function claim - would be by conducting one or more drug-like randomized clinical trials (RCTs) on the product. The expert testified that the balance Congress struck in enacting the dietary supplement regulatory regime is irrelevant and should simply be ignored. He said that the "only way" to substantiate claims for drugs and human dietary supplements is to conduct drug-level RCTs, and that scientific evidence from animal, in vitro, or genetic studies could never be used to substantiate supplement claims. He also revealed that his analysis did not consider the significant cost of doing RCTs to meet his testing criteria.
The Court rejected that approach and found that Bayer was not required to have drug-level RCTs to substantiate the structure/function claims for PCH and that it would not hold Bayer in contempt because it had a robust internal process to substantiate claims.
The government asserted Bayer made "implied" claims that the probiotic can help cure, prevent and treat constipation, diarrhea, gas and bloating. Judge Linares said such words - prevent, treat and cure - did not transform Bayer's statements into disease claims. He said Bayer's statements were so-called structure/function claims, which DSHEA permits. "Although the words 'prevent, treat and cure' often signal a disease claim, the government has not proven that Bayer advertised PCH to prevent, treat or cure any disease," Judge Linares wrote. "Instead, the government asserts that Bayer advertised PCH to prevent, treat or cure constipation, diarrhea, gas and bloating. These are not diseases, but rather variations of the normal state of health."