Supplement Claims Need Healthy Support, Not A Disease Cohort

Supplement firms should ensure supporting studies for structure/function claims avoid drug treatment findings, says NPA CEO Dan Fabricant. People with “higher-end-of-normal” range of health issues are critical to avoiding trial outcomes that attract FTC scrutiny.

Studies to support dietary supplement claims should be carefully designed to demonstrate an ingredient’s benefits without mimicking drug treatment trials, says Natural Products Association head Daniel Fabricant.

Firms can avoid crossing the drug treatment line when they recruit people as subjects in their studies, Fabricant said on April 22 at a Food & Drug Law Institute meeting panel discussion on FTC scrutiny of structure/function claims.

“We advise member companies to look at healthy but higher-end-of-normal range” of a certain health condition characteristic in the people they recruit for studies, he said.

Once past the normal range, a group represents a disease cohort, Fabricant suggested.

For example, for cholesterol-lowering benefits associated with a supplement's fiber ingredients, a firm should consider treatment subjects with cholesterol levels in the “slightly higher-than-normal range” to demonstrate the benefits of taking the product versus a placebo; but the study should avoid subjects with abnormally high cholesterol levels – positive effects for those subjects could push the study into disease treatment territory.

“If everything is right in terms of the structure of the study, hopefully there's no challenge” from the FTC, Fabricant said.

He addressed clinical trials as part of a larger discussion on scientific evidence FTC prioritizes in deciding whether supplement firms overstep boundaries with ad claims (see story this issue, (Also see "Heavier FTC Scrutiny Puts Pressure On Consumer Health Product Claims" - Pink Sheet, 28 Apr, 2015.)).

Tracing Claims To The Source

Fabricant says marketers should know not to make disease claims. “The FTC has been very smart going after people with disease claims as targets of enforcement,” he said. “It's tough to defend them and you certainly can't make them by law on the FDA side of things.”

However, he acknowledges a fuzzy line between claims that a product treats a disease and claims that a product can impact various aspects of a disease state, a critical tool in selling the attributes of a product.

Health claims approved by FDA as meeting the significant scientific agreement standard and qualified health claims characterize the relationship between a substance and a disease or health condition, while structure/function claims describe the effect a substance has on the structure or function of the body and do not make reference to a disease.

However, FDA cautions that statements intended as health or structure/function claims can be inferred as disease claims.

“It may not be possible always to draw a bright line between structure/function and disease claims. You should look at the objective evidence in your labeling to assess whether a claim explicitly or implicitly is a disease claim,” FDA says on its guidance, “Structure/Function Claims, Small Entity Compliance Guide.”

An example is a statement “may not mention a disease but may refer to identifiable characteristic signs of symptoms of a disease such that the intended use of the product to treat or prevent the disease may be inferred,” the agency states.

Companies can draw a bright line by taking control of claims at their source – the clinical trial phase, suggested Fabricant.

He said more marketers are conducting their own studies or partnering with raw ingredient suppliers who traditionally provided their own clinical trial data to manufacturers.

“Those who have something to lose, I think they are really going to look to partner closely with the ingredient suppliers to conduct those trials,” Fabricant said in an interview. “What we have seen are community-type trials on ingredients [or blends] that will be sold downstream to ingredient firms” who then can present that information to finished product marketers.

Those efforts help create cohesiveness and quality in the process – aspects emphasized during the panel by the Federal Trade Commission’s Richard Cleland.

Cleland, assistant director in FTC’s Division Advertising Practice Addressing, said for data integrity in clinical trials, “you need more than what is on the paper.” For claim substantiation, firms “must have available for inspection and protection, underlying data on their studies,” he said.

Too often, FTC has pushed companies to provide clinical data behind studies only to have the firm respond they cannot provide the data because they cannot access it from their raw material supplier, Cleland added (Also see "‘Distressing’ Substantiation Trends Tighten FTC Supplement Claim Enforcement" - Pink Sheet, 23 Apr, 2015.).