Jonathan F. Cohn, Partner, and Benjamin M. Mundel, Associate, of Sidley Austin LLP11.10.15
For well over a decade, the law regulating dietary supplements was clear. Recognizing the many health benefits of supplements, Congress enacted the Dietary Supplement Health & Education Act of 1994 (DSHEA), Pub. L. No. 103-417, sec. 8, § 413(c) (codified at 21 U.S.C. § 350(b)), to ensure that supplements can be marketed and sold without following the stringent requirements imposed on prescription drugs.
Whereas new drugs must be pre-approved by the Food and Drug Administration,1 and traditionally must be supported by randomized, double-blind, placebo-controlled clinical trials, Congress applied an appropriately different standard for dietary supplements. Dietary supplement structure-function claims need only be “truthful and not misleading.”2 According to the “FTC Guidance” enacted after DSHEA, it is sufficient that supplement claims be supported by “competent and reliable scientific evidence,” which is a “flexible” standard.3 “There is no fixed formula for the number or type of studies required,” and even animal and in vitro studies can be considered.4
However, starting in 2009, the FTC decided it wanted to raise the standard for dietary supplements. The agency had lost a number of enforcement and contempt actions and according to the then-Director of the FTC Bureau of Consumer Protection David Vladeck, the FTC “need[ed] to take steps to make our standard injunctive language … more exact.”5 But rather than following proper procedure—such as lobbying Congress to change the law, conducting notice-and-comment rulemaking, or even revising its own Guidance—the FTC attempted to impose a novel drug-level substantiation standard on industry through threats of litigation. The agency began investigations into a number of companies and, with threats of exorbitant damages, moved to the higher standard in new consent decrees, requiring randomized controlled clinical trials.6
Following a similar path, the FTC began an investigation into Bayer and sought to force the company into revising its consent decree to adopt a clinical trial substantiation standard. After Bayer refused to accept those demands, the Department of Justice, litigating on behalf of the FTC, brought a civil contempt action alleging that Bayer had marketed a probiotic dietary supplement, Phillips’ Colon Health, in violation of the prior consent decree, which required only “competent and reliable scientific evidence.”
The government sought hundreds of millions of dollars in contempt damages and $25,000 a day in fines. The government’s sole basis for contempt was that “competent and reliable scientific evidence” did require drug-level, randomized, double-blind, placebo-controlled clinical trials, notwithstanding the published Guidance.
After a two-and-a-half week bench trial, Judge Jose Linares of the United States District Court for the District of New Jersey denied the Government’s contempt motion in its entirety. The Court rejected the FTC’s demand for drug-level clinical trials for dietary supplements, holding that the standard was invalid. The Court also stressed the scientific substantiation and expert testimony supporting Bayer’s claims. This decision should help clarify the law for industry. In addition, there are two key lessons industry can learn from the case:
1) Implement A Copy-Review Process
First, it is essential that dietary supplement companies implement a robust copy-review process. In ruling for Bayer, the Court relied heavily on Bayer’s copy-review process and dedicated a significant portion of the opinion to describing Bayer’s process. The Court explained that “in order to ensure that it complies with the Consent Decree, [Bayer] follows an extensive process known as the Legal, Medical, Regulatory (LMR) review.” This process requires one member of the legal, medical, and regulatory groups to regularly attend meetings and to review every single piece of promotional material the company wished to publicize.
At these meetings, the medical representative is responsible for ensuring scientific and medical substantiation for all claims. The regulatory representative ensures that all FDA regulations, including those on structure-function claims and required disclaimers are complied with. The individual from the legal team reviews the advertisements for general legal compliance.
If Bayer’s scientist is not convinced that every single claim is completely truthful and fully substantiated, she will not approve the advertisement, and it will not be published. Similarly, if the legal or regulatory representative does not believe that the advertisement complies with all laws and regulations, it will be rejected. This process starts at idea generation and continues through the life of every product Bayer sells. This process was significant to the Court’s decision and Bayer’s success in this case.
Bayer’s LMR process is just one example of a robust and successful copy-review process. Each company should have its own individual process tailored to its structure, products and culture, and preferably reviewed by counsel that has substantial experience in drafting and reviewing procedures for supplement copy-review.
The benefits of a copy-review process begin well before litigation. A process that ensures proper claims on the front end can help companies minimize litigation risk and legal expense down the road. Further, in the event there is litigation, a robust process goes a long way to showing that the company acted in good faith and made substantial efforts to comply with the law.
2) Utilize Knowledgeable Experts
Second, companies must retain knowledgeable and appropriate experts, both for litigation, and also for the substantiation and copy-review process. Industry should focus on experts in the relevant area, with top credentials, and the ability to withstand cross-examination. Bayer experts met these criteria. As the Court explained, Dr. Daniel Merenstein is “a leading expert on probiotics[,] has been a lead investigator on eight probiotic clinical trials,” and has “given national and international lectures” on probiotics. And Dr. M. Brian Fennerty has “many hundreds of publications” in gastroenterology, including in the New England Journal of Medicine, and the Journal of the American Medical Association. Dr. Fennerty also “has done research on probiotics and the gut microbiome,” uses probiotics in his practice, and has “reviewed ‘many hundreds, if not thousands’ of studies on probiotics in his career.”
Both of Bayer’s experts testified that drug-level randomized controlled trials were not required for probiotic supplements. The Court credited this testimony, and rejected the testimony of the government expert who lacked expertise in probiotics. Dr. Laine admitted that he “is not an expert on probiotics” and “does not regularly use them in his practice.” Dr. Laine also conceded that he was not familiar with DSHEA, “did not review or consider FDA regulations in any way,” was not aware of the distinction between “structure function claims for dietary supplements and disease claims for drugs.” In fact, during cross-examination, Dr. Laine confessed he was “not paying attention to the law or regulation about the difference between dietary supplement and drugs.” Given this testimony, it is unsurprising that the Court held: “Dr. Laine lacks the expertise necessary to prove what experts in the field would require” and he simply “is not in a position to testify” regarding the relevant standard.
Experts are also critical to the copy-review process, because a medical and scientific review is only as strong as the individuals performing it. A company’s scientists must be able to locate, review and synthesize a vast amount of scientific literature to determine whether or not a claim is substantiated. The scientific and medical team must also have the ability to stand firm if a marketer wants to expand claims beyond the scientific support. In U.S. v. Bayer, the Court gave special recognition to Dr. Pana Beke, “Bayer’s lead medical employee responsible for the substantiation of Bayer’s [supplement] claims.” The Court heavily relied on her efforts to ensure that Bayer’s claims were substantiated, and specifically noted that she “look[ed] at all of the literature in the public domain” on the product, “talk[ed] to [other] experts,” and relied on “the totality of evidence … to make sure that the claims for the product were adequately substantiated.”
The Court’s decision in U.S. v. Bayer is welcome news to industry. These two insights from the trial should help companies ward off litigation, and, if necessary, win at trial when the FTC oversteps its bounds.
Jonathan F. Cohn is a partner and Benjamin M. Mundel is an associate at Sidley Austin LLP in the firm’s Washington, D.C. office.
Disclaimer: Jonathan F. Cohn and Benjamin M. Mundel were members of the Sidley Austin LLP trial team that represented Bayer Corp. in this litigation.
This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and the receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. The content therein does not reflect the views of the firm.
Whereas new drugs must be pre-approved by the Food and Drug Administration,1 and traditionally must be supported by randomized, double-blind, placebo-controlled clinical trials, Congress applied an appropriately different standard for dietary supplements. Dietary supplement structure-function claims need only be “truthful and not misleading.”2 According to the “FTC Guidance” enacted after DSHEA, it is sufficient that supplement claims be supported by “competent and reliable scientific evidence,” which is a “flexible” standard.3 “There is no fixed formula for the number or type of studies required,” and even animal and in vitro studies can be considered.4
However, starting in 2009, the FTC decided it wanted to raise the standard for dietary supplements. The agency had lost a number of enforcement and contempt actions and according to the then-Director of the FTC Bureau of Consumer Protection David Vladeck, the FTC “need[ed] to take steps to make our standard injunctive language … more exact.”5 But rather than following proper procedure—such as lobbying Congress to change the law, conducting notice-and-comment rulemaking, or even revising its own Guidance—the FTC attempted to impose a novel drug-level substantiation standard on industry through threats of litigation. The agency began investigations into a number of companies and, with threats of exorbitant damages, moved to the higher standard in new consent decrees, requiring randomized controlled clinical trials.6
Following a similar path, the FTC began an investigation into Bayer and sought to force the company into revising its consent decree to adopt a clinical trial substantiation standard. After Bayer refused to accept those demands, the Department of Justice, litigating on behalf of the FTC, brought a civil contempt action alleging that Bayer had marketed a probiotic dietary supplement, Phillips’ Colon Health, in violation of the prior consent decree, which required only “competent and reliable scientific evidence.”
The government sought hundreds of millions of dollars in contempt damages and $25,000 a day in fines. The government’s sole basis for contempt was that “competent and reliable scientific evidence” did require drug-level, randomized, double-blind, placebo-controlled clinical trials, notwithstanding the published Guidance.
After a two-and-a-half week bench trial, Judge Jose Linares of the United States District Court for the District of New Jersey denied the Government’s contempt motion in its entirety. The Court rejected the FTC’s demand for drug-level clinical trials for dietary supplements, holding that the standard was invalid. The Court also stressed the scientific substantiation and expert testimony supporting Bayer’s claims. This decision should help clarify the law for industry. In addition, there are two key lessons industry can learn from the case:
1) Implement A Copy-Review Process
First, it is essential that dietary supplement companies implement a robust copy-review process. In ruling for Bayer, the Court relied heavily on Bayer’s copy-review process and dedicated a significant portion of the opinion to describing Bayer’s process. The Court explained that “in order to ensure that it complies with the Consent Decree, [Bayer] follows an extensive process known as the Legal, Medical, Regulatory (LMR) review.” This process requires one member of the legal, medical, and regulatory groups to regularly attend meetings and to review every single piece of promotional material the company wished to publicize.
At these meetings, the medical representative is responsible for ensuring scientific and medical substantiation for all claims. The regulatory representative ensures that all FDA regulations, including those on structure-function claims and required disclaimers are complied with. The individual from the legal team reviews the advertisements for general legal compliance.
If Bayer’s scientist is not convinced that every single claim is completely truthful and fully substantiated, she will not approve the advertisement, and it will not be published. Similarly, if the legal or regulatory representative does not believe that the advertisement complies with all laws and regulations, it will be rejected. This process starts at idea generation and continues through the life of every product Bayer sells. This process was significant to the Court’s decision and Bayer’s success in this case.
Bayer’s LMR process is just one example of a robust and successful copy-review process. Each company should have its own individual process tailored to its structure, products and culture, and preferably reviewed by counsel that has substantial experience in drafting and reviewing procedures for supplement copy-review.
The benefits of a copy-review process begin well before litigation. A process that ensures proper claims on the front end can help companies minimize litigation risk and legal expense down the road. Further, in the event there is litigation, a robust process goes a long way to showing that the company acted in good faith and made substantial efforts to comply with the law.
2) Utilize Knowledgeable Experts
Second, companies must retain knowledgeable and appropriate experts, both for litigation, and also for the substantiation and copy-review process. Industry should focus on experts in the relevant area, with top credentials, and the ability to withstand cross-examination. Bayer experts met these criteria. As the Court explained, Dr. Daniel Merenstein is “a leading expert on probiotics[,] has been a lead investigator on eight probiotic clinical trials,” and has “given national and international lectures” on probiotics. And Dr. M. Brian Fennerty has “many hundreds of publications” in gastroenterology, including in the New England Journal of Medicine, and the Journal of the American Medical Association. Dr. Fennerty also “has done research on probiotics and the gut microbiome,” uses probiotics in his practice, and has “reviewed ‘many hundreds, if not thousands’ of studies on probiotics in his career.”
Both of Bayer’s experts testified that drug-level randomized controlled trials were not required for probiotic supplements. The Court credited this testimony, and rejected the testimony of the government expert who lacked expertise in probiotics. Dr. Laine admitted that he “is not an expert on probiotics” and “does not regularly use them in his practice.” Dr. Laine also conceded that he was not familiar with DSHEA, “did not review or consider FDA regulations in any way,” was not aware of the distinction between “structure function claims for dietary supplements and disease claims for drugs.” In fact, during cross-examination, Dr. Laine confessed he was “not paying attention to the law or regulation about the difference between dietary supplement and drugs.” Given this testimony, it is unsurprising that the Court held: “Dr. Laine lacks the expertise necessary to prove what experts in the field would require” and he simply “is not in a position to testify” regarding the relevant standard.
Experts are also critical to the copy-review process, because a medical and scientific review is only as strong as the individuals performing it. A company’s scientists must be able to locate, review and synthesize a vast amount of scientific literature to determine whether or not a claim is substantiated. The scientific and medical team must also have the ability to stand firm if a marketer wants to expand claims beyond the scientific support. In U.S. v. Bayer, the Court gave special recognition to Dr. Pana Beke, “Bayer’s lead medical employee responsible for the substantiation of Bayer’s [supplement] claims.” The Court heavily relied on her efforts to ensure that Bayer’s claims were substantiated, and specifically noted that she “look[ed] at all of the literature in the public domain” on the product, “talk[ed] to [other] experts,” and relied on “the totality of evidence … to make sure that the claims for the product were adequately substantiated.”
The Court’s decision in U.S. v. Bayer is welcome news to industry. These two insights from the trial should help companies ward off litigation, and, if necessary, win at trial when the FTC oversteps its bounds.
Jonathan F. Cohn is a partner and Benjamin M. Mundel is an associate at Sidley Austin LLP in the firm’s Washington, D.C. office.
Disclaimer: Jonathan F. Cohn and Benjamin M. Mundel were members of the Sidley Austin LLP trial team that represented Bayer Corp. in this litigation.
This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and the receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. The content therein does not reflect the views of the firm.
1) See 21 U.S.C. § 331(d); id. § 355(a).
2) 21 U.S.C. § 343(r)(6)(B); see also id. § 321(ff) (defining “dietary supplement” as any non-tobacco product “intended to supplement the diet”); id. § 343(r)(6)(A) (identifying types of dietary supplement claims, including structure-function claims); id. § 343(r)(6)(A) (defining a structure-function claim as a claim that “describe[s] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans [or] characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function”).
3) Dietary Supplements: An Advertising Guide for Industry at 3 (“FTC Guidance”).
4) Id. at 8-9.
5) “Priorities for Dietary Supplement Advertising Enforcement” Remarks by David C. Vladeck, Director FTC Bureau of Consumer Protection, October 22, 2009.
6) See e.g., FTC v. Iovate Health Sci USA, Consent Decree at 7, No. 10-CV-587 (W.D.N.Y. July 29, 2010); United States v. Jason Pharm., Inc., Consent Decree at 3, 6, No. 12-CV-01476 (D.D.C. Sept. 17, 2012).
