The US Department of Justice, on behalf of the FTC, alleges that Bayer promotes Phillips’ Colon Health uses claims about the product’s purported benefits without having evidence to substantiate those claims.
In its motion, the United States alleges that Bayer expressly claims Phillips’ Colon Health can “defend against” occasional constipation, diarrhea, and gas and bloating, and impliedly claims that Phillips’ Colon Health prevents, treats and cures constipation, diarrhea, and gas and bloating, even though the company “lacks competent and reliable scientific evidence for those claims”, an allegation the company strongly disputes.
“The Department of Justice will not tolerate companies that seek to gain an unfair advantage over their competitors by promoting to consumers unsubstantiated claims about the health benefits of their products,” said Assistant Attorney General Stuart F. Delery for the department’s Civil Division.
The FTC/DoJ also alleges that Bayer has violated a 2007 consent decree that prohibited the company making unsubstantiated claims for any dietary supplement it promotes or sells.
‘We will defend ourselves vigorously’
When contacted by NutraIngredients-USA, the company issued the following statement: “Bayer is extremely disappointed and strongly disagrees with the US FTC decision to bring a motion against the company for claims made in support of Phillips’ Colon Health. Phillips’ Colon Health is a safe and beneficial probiotic product. Bayer believes that the product’s benefits for consumers are fully substantiated and supported. We will defend ourselves vigorously.
“Probiotic bacteria, including the three species used in Phillips’ Colon Health, have a long and well-documented safety record, complemented by volumes of human clinical studies on their digestive benefits. It is this research upon which Bayer has legitimately based all of our claims, which include the fact that the product will ‘promote overall digestive health’ and ‘help defend against occasional constipation, diarrhea, and gas and bloating’. It is important to note that Bayer never made any claims suggesting that Phillips’ Colon Health should be used to mitigate, prevent or treat any disease.
‘Cutting-edge genomic research supporting our structure-function claims’
2007 civil complaint against One-A-Day WeightSmart
The US filed a civil complaint alleging that Bayer made unsubstantiated claims for its One-A-Day WeightSmart product. The claims included that, among other things, the product helped prevent some of the weight gain associated with a decline in metabolism in users over the age of 30.
In order to resolve the complaint’s allegations, in 2007, Bayer agreed to pay a $3.2 million civil penalty and agreed that it would not make unsubstantiated representations regarding the benefits, performance, efficacy, safety or side effects of any dietary supplement, multivitamin or weight-control product.
“Bayer disagrees with the FTC’s assertion that Bayer must possess two randomized, placebo-controlled, double-blind human clinical trials for the exact combination of strains of bacteria used in Bayer’s product. This standard of clinical evidence is generally required for drugs and is not necessary or required to support dietary supplement claims such as those that Bayer made in support of Phillips’ Colon Health.
"Furthermore, as we’ve informed the government, Bayer has cutting-edge genomic research supporting our structure-function claims. Bayer therefore believes that this assertion by the FTC is contrary to law, the policy of the United States Food and Drug Administration and previous FTC Guidance.
“Further, we disagree with the FTC’s allegation that Bayer is in violation of an earlier consent decree. The 2007 settlement with the FTC over claims made in support of a different dietary supplement, which Bayer entered into without any admission of guilt or wrongdoing in order to expeditiously resolve the earlier complaint, specifically required that Bayer possess ‘competent and reliable scientific evidence’ for future dietary supplement claims. Again, Bayer believes that the company possesses such evidence for all claims made in support of Phillips’ Colon Health.
“Based on these and other facts, Bayer does not believe any payment is warranted.”
CRN: ‘This action does concern us’
Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), told us that the claims that the DoJ is challenging are “legitimate structure-function claims, and not disease claims like we’ve seen in other high profile FTC actions. Substantiation for structure-function claims is competent, reliable scientific evidence, but it now appears that the FTC is requiring multiple drug-like randomized controlled trials for a dietary supplement product that has been substantiated as safe and beneficial.
“Structure/function claims have never been held solely to the multiple RCT standard that the FTC now seeks to impose through this enforcement activity. Requiring these claims to be supported by multiple RCTs, without regard for other credible methods of analysis, would hold dietary supplements to unreasonable, inflexible, and pharmaceutical-like standards, which contradicts how dietary supplements are defined and regulated under the law.”
“This action does concern us,” he added. “We see outrageous claims on products claiming to treat and cure disease – we see them in magazines, on television, on the internet – and we think that FTC resources would be much better spent going after those claims.”
‘Important case law’
The Natural Products Association’s Dr Dan Fabricant told us that ‘occasional’ claims are permissible in the regulations, (as Bayer makes with this product – see product picture above), and that makes this “important case law”.
“At this stage it’s still just allegations, and if that’s the basis then I think DoJ will be fighting an uphill battle.”