FTC Litigation Update: FTC v. Bayer Litigation: What Type of Evidence Is Needed to Substantiate Probiotic Claims?
Monday, June 15, 2015 marked the beginning of the newest chapter of litigation between Bayer Corporation (“Bayer”) and the U.S. Justice Department, arguing on behalf of the Federal Trade Commission (“FTC“), regarding Bayer’s potential violation of a 2007 consent decree. FTC, the agency that oversees and regulates dietary supplement advertisements, has filed suit alleging that Bayer violated a 2007 consent decree when it made unsubstantiated claims about one of its probiotic dietary supplements.
In 1994, Congress amended the Food, Drug, and Cosmetic Act to include the Dietary Supplement Health and Education Act (“DSHEA“). DSHEA defines what a dietary supplement is and sets forth the legal framework for the dietary supplement industry. The Food and Drug Administration (“FDA“) has regulatory authority over the labeling and manufacturing of food, drugs, and medical devices, and it shares jurisdiction with FTC over the advertising of those same products.
While FTC and FDA share authority over dietary supplement marketing, each agency has a different regulatory focus with a different standard. Per FDA, manufacturers of dietary supplements are not required to obtain approval from the FDA, while prescription drugs and medical devices advertisers are. On the other hand, FTC requires dietary supplement advertisements to meet the same substantiation threshold as drug and medical devices: competent and reliable scientific evidence. FTC defines “competent and reliable scientific evidence” in its policy guide entitled “Dietary Supplements: An Advertising Guide for Industry” as:
tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.
FTC further states there “is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration.” See FTC Policy Guide. However, FTC has been attempting to narrow “competent and reliable scientific evidence” through consent decrees (settlements with private parties that are not developed via the Administrative Procedure Act’s notice-and-comment rulemaking process) to exclusively be defined as two randomized, well-controlled, double-blind clinical trials (“RCTs”). As we have previously reported (here, here, andhere), this re-defined standard has created confusion among the dietary supplement industry as to the definition of “competent and reliable scientific evidence.”
The current litigation between FTC and Bayer is a battle over what type of substantiation is required to meet FTC’s standards for dietary supplements. The issue before the Court is whether Bayer satisfied FTC’s “competent and reliable” scientific standard without the use of clinical testing. Both the Government and Bayer concede the appropriate standard was one for dietary supplements, but Bayer argues that FTC’s substantiation standard for dietary supplements should not include multiple RCTs since FDA limits requiring RCTs to prescription drugs and devices.
Background-The 2007 Consent Decree
FTC brought suit against Bayer in 2007 to “cease and desist certain advertising practices with respect to One-A-Day brand vitamin and mineral supplements.” See Consent Decree. Bayer subsequently entered into a consent decree with FTC, which requires Bayer to “possess[ ] and rely upon competent and reliable scientific evidence” before any representations regarding “the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any dietary supplement, [or] multivitamin.” Id. Therefore, before Bayer can make claims about any dietary supplement, the claims must be backed by competent and reliable scientific evidence.
The U.S. Government is now accusing Bayer of advertising a probiotic-Phillips Colon Health Supplement-without possessing “competent and reliable scientific evidence.” Per Bayer’s advertisements, the probiotic helps “defend against occasional constipation, diarrhea, and gas and bloating.” In 2014, the Department of Justice (representing FTC), “filed a motion to show cause why Bayer should not be held in civil contempt for violating” the court order. (To read the Department of Justice News Release, please click here.) The government “alleges that consumers have paid hundreds of millions of dollars for Phillips’ Colon Health, even though Bayer lacks the evidence to support the claims of the purported benefits.” Id.
The Government’s Argument
The government contends that Bayer violated the consent decree by not possessing sufficient evidence to support the probiotic claims advertised. To convince the Court of its position, the government enlisted an expert gastroenterologist and an expert microbiologist “to review[ ] the materials produced by Bayer’s counsel” and “concluded the totality of evidence shows Bayer lacks competent and reliable scientific evidence to substantiate the specific claims.” Government’s Trial Brief at 7.
The government argues that Bayer’s claims are not backed by competent and reliable scientific evidence because the claims about the supplement’s probiotic bacteria were not supported by “any materials, such as studies or papers, when making the specific claims at issue.” Id. at 5. Rather, Bayer only “produced to the FTC approximately 100 papers and several cover letters as purposed substantiation.” Id. at 5. The government asserts that substantiating probiotic claims “requires an RCT of a daily dose of the actual, three-bacteria strain formula . . . to which Bayer asserts its claims are addressed: healthy people.” Id. at 8. According to the Government, the papers and cover letters submitted by Bayer to FTC failed to accomplish that task.
Bayer insists that it has not violated the consent decree because the company has provided sufficient evidence to substantiate its probiotic claims. Bayer argues that the consent decree does not delineate the specific type of evidence that satisfies the competent and reliable substantiation standard. Therefore, to comply with the competent and reliable standard, Bayer conducted a literature review which included a dozen human studies to support its claims and comply with the consent decree. Further, “Bayer produced almost 100 studies to the government.” However, the government was not satisfied with Bayer’s literature and pushed the contempt order forward.
Bayer now argues that FTC is attempting to implement a new standard for dietary supplements by requiring the same type of substantiation for dietary supplements as it does drugs. (To read Bayer’s trial brief, please click here.) This new standard would force “all dietary supplement claims . . . [to] be supported with the same product-specific RCTs required to prove safety and efficacy in order to obtain FDA approval to market a drug.” Bayer’s Brief page 3. This “drug-like substantiation,” as Bayer calls it, “is wholly inconsistent with DSHEA” and allowing a new standard “would undo exactly what Congress enacted DSHEA to accomplish.” Id. at 6. According to Bayer, this new standard of competent and reliable evidence to be redefined as RCTs “would transform the product [dietary supplements], as a matter of law, from a food into a drug.” Id. at 7.
What Does This Mean For the Dietary Supplement Industry?
Ultimately, a judge will decide if Bayer’s substantiation is sufficient, or if FTC’s requirement for RCTs will prevail. Nevertheless, the dietary supplement industry is monitoring the ongoing saga between Bayer and FTC closely. If the judge rules that RCTs are required for dietary supplement substantiation, the resulting standard of substantiation would impact the entire industry.
Fuerst Ittleman David & Joseph, PL is monitoring the litigation between the Department of Justice and Bayer. The attorneys in our Food, Drug, and Life Sciences practice group are experienced in assisting regulated industry to ensure that products are marketed and advertised in compliance with all applicable federal laws and regulations. For more information, please call us at firstname.lastname@example.org email us at