FTC's Clinical Trial Requirement Threatens Food Claim Rules

The National Advertising Review Board, the appellate body of the National Advertising Division, recently fully embraced the Federal Trade Commission's 2022 guidance on randomized, controlled human clinical trials, or RCTs — the most expensive and highest level of medical research available.

The guidance purported to require RCTs for any product — from an omega supplement to a prescription drug — making any type of health benefit claim, from a claim to "support heart health" to a claim to "treat chronic heart failure."

While the FTC has yet to base any enforcement action on its guidance, the NARB proclaimed last month in the case of Niagen Biosciences Inc. that the FTC "require[s] randomized controlled human clinical studies," as outlined in the 2022 guidance, "for most health-benefit claims," and thus, so will the NAD and NARB. [1]

However, any such sweeping requirement not only lacks any legal basis, but also threatens the existing intricate statutory framework that Congress created for marketing claims for food and dietary supplements, versus drugs.

CARSE and the Pfizer Factors

The U.S. Food and Drug Administration and FTC share jurisdiction over a wide variety of products, from prescription drugs to food and dietary supplements.

The FDA enforces the Food, Drug and Cosmetic Act, which establishes regimes for how companies must create and market such products. [2] The FTC, on the other hand, enforces the FTC Act, which prohibits false advertising and deceptive acts or practices. [3]

For decades, both agencies required health benefit claims for food and dietary supplements to be supported by "competent and reliable scientific evidence," or CARSE. [4]

Regulatory guidance, as well as the courts, defined CARSE as a requirement for research that scientific experts in the relevant field find reliable, regardless of what form that research might take. [5] Likewise, regulators and the courts recognized that the so-called Pfizer factors — established in the FTC's 1972 decision in In re: Pfizer Inc. — including the type of product and claim, must also be considered in assessing the requisite level of substantiation. [6]

The 2022 FTC guidance, however, purports to skip looking to scientific expertise or the Pfizer factors and instead impose a general requirement for clinical studies. Specifically, the guidance states:

• "As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing"; and
• "Randomized, controlled human clinical trials (RCTs) ... are generally the type of substantiation that experts would require for health benefit claims." [7]

The 2022 guidance further provides that required RCTs should not only be randomized and controlled, but also "blinded to the fullest extent possible," yield statistically significant results between groups, avoid any post-hoc analysis, yield clinically meaningful results, have a clear and detailed protocol that has been reviewed by an institutional review board, be registered in a public database, include clear inclusion and exclusion criteria, use intent to treat analysis, be of sufficient duration, have a formal manuscript, and be subject to "rigorous, unbiased peer review." [8]

Why an RCT Requirement for Dietary Supplement and Food Claims Fails as a Legal Matter

As support for its position that RCTs are generally required for claims about health benefits, the 2022 FTC guidance cites a total of eight cases. [9]

However, rather than support an RCT requirement, those cases simply show the longstanding CARSE and Pfizer analyses at work.

Four of the eight cases cited involved claims to treat diseases such as cancer. [10]

One case, FTC v. National Urological Group, decided by the U.S. District Court for the Northern District of Georgia in 2017, involved weight loss claims, like "Benzedrine simply blows fat away." [11]

The final three cases involved were FTC v. Roca Labs Inc., decided by the U.S. District Court for the Middle District of Florida in 2018, FTC v. COORGA Nutraceuticals Corp., decided by the U.S. District Court for the District of Wyoming in 2016, and FTC v. Femovatron International Corp., decided by the U.S. Court of Appeals for the First Circuit in 1989.

These cases involved, respectively, claims that a drink could substitute for gastric bypass surgery, claims to permanently remove unwanted hair, and claims to prevent or permanently reverse gray hair. [12]

In each of the eight cases, the court found the claims at issue to be particularly strong. For instance, in FTC v. Direct Marketing Concepts Inc. in 2010, the First Circuit observed that the defendants "shill[ed] purported panaceas," and "claimed [to] cure[] literally every disease." [13]

After reviewing the claims, the courts next assessed the level of support the defendants possessed based on expert testimony.

The court in Roca Labs, for instance, accepted expert testimony that "experts in the field of obesity treatment and weight loss would require well-designed and properly conducted clinical trials" as CARSE for weight loss claims. [14]

In COORGA, the court accepted expert testimony that "to substantiate claims that" the product at issue can "reverse or prevent the formation of gray hair, experts in the field of dermatology, specifically hair, would require at least one well-designed, randomized, placebo-controlled, and double-blinded human clinical trial." [15]

The courts, finally, found that claims lacked the substantiation such experts in the field would require.

The same factual analysis has been at play in several cases in recent years in which the FTC failed to convince courts that dietary supplement structure/function claims require the high level of RCT support the agency is now advancing. [16]

For instance, U.S. v. Bayer Corp., decided by the U.S. District Court for the District of New Jersey in 2015, involved claims that a probiotic supplement "helps defend against occasional constipation, diarrhea, gas, and bloating." [17]

Bayer relied on clinical studies employing various designs to test one or more probiotic strains in various populations. [18] Two experts offered by Bayer concluded that the evidence was adequate. [19]

The FTC's scientific expert opined that the evidence was inadequate, given that no single study constituted a clinical study that among other attributes was on the full product formulation, was "randomized, placebo-controlled, and double-blind," and "used validated methods and appropriate statistical methods to assess outcomes." [20]

The court sided with Bayer, finding that testimony by the FTC's expert "conflicts with the longstanding understanding" of the competent and reliable scientific evidence standard. [21]

A Threat to FDCA Claims Regimes

Turning first to the FDCA drug standard demonstrates the illogic of the FTC's position in its 2022 guidance.

To approve new, nongeneric prescription drugs, the FDA must find substantial evidence of effectiveness, defined as evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. [22]

The FDA's guidance on the standard further explains that "[a]lthough randomized double-blinded, concurrently controlled superiority trials are usually regarded as the most rigorous design," "five types of controls" including "no treatment concurrent control" or a "historical control" may suffice. [23]

The guidance acknowledges potential weaknesses, such as studies with no treatment concurrent control necessarily being unblinded. [24] The guidance explains, though, that while such designs "may be more difficult to interpret," "different trial designs (including choice of control) may be appropriate in different disease settings." [25] Thus, this standard for prescription drugs is inexplicably less stringent than the FTC's RCT requirement in its 2022 guidance.

Turning next to FDCA standards for food and dietary supplements demonstrates that Congress never intended an RCT requirement like the FTC and NARB are advancing.

With the Dietary Supplement Health and Education Act of 1994, Congress exempted dietary supplements from FDA drug approval, placing dietary supplements instead within the category of food. [26]

DSHEA further created a claims regime specifically for dietary supplements. DSHEA allows, without FDA preapproval, two types of claims: "general well-being" claims, as well as "structure/function claims," which describe either the role or mechanism by which a nutrient or dietary ingredient affects the body's structure or function. [27]

A general well-being claim might state, for instance, that a multivitamin "supports wellness." Structure and function claims encompass claims that a dietary supplement supports the body generally (e.g., "Vitamin B12 supports the nervous system") and claims about certain nondisease cause-and-effect outcomes (e.g., "improves focus"). [28]

Under DSHEA, general well-being claims and structure and function claims may not promote a dietary supplement for "diagnos[ing], mitigat[ing], treat[ing], cur[ing], or prevent[ing] a specific disease or class of diseases," and the marketer must possess "substantiation that such statement is truthful and not misleading." [29]

Following passage of DSHEA, the FDA acknowledged that, under other FDCA provisions, such claims could also be made for other foods. [30] Congress never defined what it meant by "substantiation that such statement is truthful and not misleading." But, we know that if it meant "adequate and well-controlled investigations," it could have said so.

Moreover, several years prior to DSHEA, the Nutrition Labeling and Education Act, for the first time, allowed food to be promoted with health claims. [31] According to the act, health claims "characterize the relationship of [a] nutrient" to disease and must be preauthorized by the FDA. [32] An example of health claim is: "Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis." [33]

To approve a health claim, the NLEA required the FDA to find significant scientific agreement, [34] which Congress described as "by design, more flexible than the standard established by law for FDA to review and approve drugs." [35]

Congress explained further that "there is no requirement that health claims be derived from clinical trials," and "[e]vidence from a broad range of reliable scientific sources should be considered" in order to maximize "disease-related information consumers can prudently use." [36]

Where Congress avoided imposing an RCT requirement on health claims, it is difficult to imagine that Congress ever intended such a requirement for general well-being or structure/function claims.

Promoting Harmony With FDCA Claims Regimes

When the FTC required CARSE and consideration of the Pfizer factors for food and dietary supplement claims, the agency's guidance aptly noted that "the FTC gives great deference to an FDA determination of whether there is adequate support" for a health benefit claim, and the "FTC and the FDA will generally arrive at the same conclusion when evaluating" health benefit claims. [37]

The 2022 FTC guidance takes an about-face, disregarding the FDA or FDCA claims standards. It states, "Unlike FDA law, FTC law makes no bright-line distinctions between categories of health-related products or claims" and that the FTC "follows the same basic steps when evaluating any health-related claim regardless of whether, under FDA law, the claim would be considered a health claim, a structure/function claim, or a drug claim." [38]

Similarly, the NARB, in its recent decision, concluded that "the statutory DSHEA structure/function standard is addressed to the Food and Drug Administration and its regulations, not to advertising standards for health [benefit] claims." [39]

With such broad interpretation of the power within advertising standards, the FTC and NARB have already begun subverting the FDCA claims standards for food and dietary supplements versus drugs.

Under this same interpretation, there is nothing stopping the FTC, NAD or NARB from undoing any other FDCA claims regimes. The FTC, NAD or NARB, for example, could prohibit drug claims already approved by the FDA if the claims fail to meet the more stringent RCT standard from the FTC's 2022 guidance.

It is, however, difficult to imagine Congress ever intended the FTC to use its enabling statute to invalidate those claims regimes Congress itself crafted under the FDCA.

This article is reprinted with permission from Law360. It was first published by Law360 on June 23, 2026.

[1] Niagen Biosciences, Inc., NARB No. 346, at 16 (May 6, 2026).

[2] 15 U.S.C. §§ 45, 52-55.

[3] 21 U.S.C. §301 et seq.

[4] FTC, Dietary Supplements: An Advertising Guide for Industry, at 9 (1998); FDA, Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, at II.A (2008).

[5] See, e.g., FTC v. Quincy Bioscience Holding Co., Inc.  , No. 17 CIV. 124 (LLS), 2022 WL 17905783, at *4 (S.D.N.Y. Dec. 19, 2022) ("what constitutes competent and reliable scientific evidence ... is a question of fact for expert interpretation").

[6] See, e.g., Pfizer Inc., 81 F.T.C. 23, 29 (1972); POM Wonderful, LLC v. FTC  , 777 F.3d 478, 490-491 (D.C. Cir. 2015).

[7] FTC, Health Product Compliance Guidance (2022), at 12-13 (internal citations omitted).

[8] Id. at 16-18.

[9] Id. at 37-38 n. 31, 33.

[10] POM Wonderful, LLC, 777 F.3d at 484; FTC v. Direct Mktg. Concepts, Inc.  , 624 F. 3d 1 (1st Cir. 2010); Thompson Med. Co., Inc., 104 F.T.C. 648 (1984); FTC v. Nat'l Urological Grp., Inc.  , No. 1:04-CV-3294-CAP, 2017 WL 6759868 (N.D. Ga. Oct. 10, 2017), aff'd, 786 F. App'x 947 (11th Cir. 2019).

[11] Nat'l Urological Grp., Inc., No. 1:04-CV-3294-CAP, 2017 WL 6759868, at *6.

[12] FTC v. Roca Labs, Inc.  , 345 F. Supp. 3d 1375 (M.D. Fla. 2018); COORGA Nutraceuticals Corp., 201 F. Supp. 3d 1300 (D. Wy. 2016); Removatron Int'l Corp., 111 F.T.C. 206 (1988) aff'd, 884 F.2d 1489, 1498 (1st Cir. 1989).

[13] Direct Mktg. Concepts, Inc., 624 F. 3d at 1.

[14] Roca Labs, Inc., 345 F. Supp. 3d at 1387.

[15] COORGA Nutraceuticals Corp., 201 F. Supp. 3d at 1310.

[16] See, e.g., United States v. Bayer Corp.  , No. CV 07-01(JLL), 2015 WL 5822595, at *8-9 (D.N.J. Sept. 24, 2015); FTC v. Garden of Life, Inc.  , 845 F. Supp. 2d 1328 (S.D. Fla. 2012), aff'd 516 F. App'x 852 (11th Cir. 2013).

[17] No. CV 07-01(JLL), 2015 WL 5822595, at *5.

[18] Id. at *7-9.

[19] Id. at *10-11.

[20] Id. at *4.

[21] Id. at *16.

[22] FDCA § 505(d) (codified at 21 U.S.C §355(d)).

[23] FDA, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, at 5 (Dec. 2019).

[24] Id.

[25] Id.

[26] Pub. Law No. 103-417, at § 3 (1994).

[27] 21 U.S.C. § 343(r)(6)(A).

[28] See, e.g., 65 Fed. Reg. 1000, 1006, 1027-1029 (Jan. 6, 2000).

[29] 21 U.S.C. § 343(r)(6)(B)-(C).

[30] See, e.g., FDA, Distinguishing Liquid Dietary Supplements from Beverages, at 8 (Jan. 2014).

[31] See Pub. Law No. 101-535, at § 2 (1990).

[32] 21 U.S.C. § 343(r)(1)(B).

[33] 21 C.F.R. § 101.72.

[34] 21 U.S.C. § 343(r)(3)(B)(1).

[35] S. Rep. 103-410, at § 4 (1994).

[36] Id.

[37] Dietary Supplements: An Advertising Guide for Industry, at 1.

[38] FTC, Health Product Compliance Guidance (2022), at 12-13 (internal citations omitted).

[39] Niagen Biosciences, Inc., NARB No. 346, at 16.