OTC Homeopathic Claims Go Under FTC Microscope, Potential For Regulatory Shift Magnifies

FTC says the homeopathic market “shifted from one based primarily on formulations prescribed for an individual user to mass-market formulations widely advertised and sold nationwide in major retail stores.” The workshop could signal FTC interest in asking for clinical trials to support for OTC homeopathic claims.

Regulatory scrutiny of over-the-counter homeopathics intensifies as the Federal Trade Commission, on the heels of FDA’s ongoing evaluation, schedules a workshop on topics including “public policy concerns” about regulation of the products.

In a June 1 announcement, the commission states one reason for the Sept. 21 public workshop is the homeopathic market “has shifted from one based primarily on formulations prescribed for an individual user to mass-market formulations widely advertised and sold nationwide in major retail stores.”

FTC also says the U.S. homeopathic drug industry has grown rapidly in recent decades, much like FDA noted in its March notice of its regulatory review.

Unlike FDA, though, FTC is pushing to require firms marketing consumer health products, which include homeopathics, to provide evidence from randomized controlled trials to support advertising claims. While the commission so far has requested results from clinical trials to support dietary supplement claims, the workshop could signal a start in asking for the same level of proof for OTC homeopathic claims.

FTC says in addition to “public policy concerns about the current regulation of homeopathic products,” the workshop will look at:

• changes in the homeopathic market, its advertising, and what consumers know
• the science behind homeopathy and its effectiveness
• the effects of recent class actions against homeopathic product companies
• the application of the FTC Act’s provision on false and misleading advertising to claims for homeopathic products.

FTC occasionally has filed complaints against OTC homeopathic marketers, particularly for weight loss products, but an official in December said differences between the commission’s and FDA’s regulatory oversight has slowed FTC’s enforcement against suspect advertising by products in the category. The basic difference is that FDA’s compliance policy guide for homeopathics allows claims for the products that do not pass FTC’s standards for advertising to be truthful and not misleading (Also see "Homeopathic Claims Have FTC Searching For Remedy To Regulatory Conflict With FDA" - Pink Sheet, 15 Dec, 2014.).

FDA, meanwhile, is considering comments on whether to maintain the agency’s homeopathy regulatory policy from a 1988 Compliance Policy Guide that recognizes an ingredient’s inclusion in the Homeopathic Pharmacopeia of the United States’ monograph as pre-market approval. In a March 27 Federal Register notice, CDER said it was starting the separate review of homeopathic drug regulations that the agency “deferred” until a later date when the OTC drug review began in 1972 (Also see "Homeopathic Regulatory Evaluation Stocked With FDA Concerns, Industry Answers" - Pink Sheet, 11 May, 2015.).

The industry, in presentations at a two-day public hearing in April and comments submitted to FDA, wants FDA to consider that the agency’s current enforcement authorities are appropriate and adequate to maintain compliance in the manufacturing and marketing of the products.

Stakeholders also have told FDA that, among reports to poison control centers for drug products, a fraction are for homeopathics compared to other Rx and OTC drugs and that annual sales are far less than the nearly $3 billion the agency has noted.

Despite the industry demurring about its sales, its growth is a big reason for FTC’s concern, says former FTC attorney Anne Maher, now a partner with Kleinfeld, Kaplan & Becker LLP in Washington.

“I think they’ve been interested in this market for a long time and I think the market has grown just tremendously over the last few years,” said Maher, who was assistant director of advertising practices in FTC’s Bureau of Consumer Protection from 1992 to 2001.

In addition to potentially question claims, FTC will look at whether homeopathic advertising could mislead consumers to confuse the products with dietary supplements or natural health product, Maher said.

Between FDA’s evaluation and FTC’s workshop, some change in regulation of homeopathic marketing or manufacturing, or both, could be coming.

Maher noted the FDA-FTC memorandum of understanding on enforcement in the consumer health care product market and the joint warning letters the agencies have submitted to homeopathic firms.

“They’ve probably coordinated to some extend with the FDA as they do,” she said, adding that FDA’s actions in its homeopathic regulatory review “will affect what the FTC will do.”

Attorney Wes Siegner, a director at Hyman, Phelps & McNamara PC in Washington, also expects regulatory changes could be ahead from one or both of the agencies.

Homeopathics were allowed to remain available in the 1938 Food, Drug & Cosmetic Act and have remained free of a pre-market approval requirement under multiple changes to the act, and FTC generally has enforced only against “blatant frauds” in claims, such as human chorionic gonadotropin products for weight loss, Siegner said in the June 5 FDA Law Blog.

“The question now is whether this 70-plus year old climate of regulatory tolerance has ended, and whether one or both agencies will severely limit or perhaps close down the market for homeopathic products by applying regulatory standards that the practice cannot survive,” he said.

Safety History, GMPs Not In FTC Focus

FTC does not look at whether regulation of homeopathic manufacturing is adequate or whether a product’s label indication is allowed, or compare the products’ safety data to other drug categories. Instead, the commission’s enforcement for all consumer product advertising, an authority stated in Sec. 5 of the FTC Act, focuses on whether claims are false and misleading.

And for consumer health products, FTC is requesting firms to provide evidence from at least two clinical trials to support their claims (Also see "‘Distressing’ Substantiation Trends Tighten FTC Supplement Claim Enforcement" - Pink Sheet, 23 Apr, 2015.).

In one of FTC’s early enforcements with a requirement for RCTs, [POM Wonderful LLC] is appealing the U.S. Court of Appeals for the District of Columbia Circuit’s January 2015 ruling largely upholding a 2013 commission order on claims made for POM Wonderful 100% Pomegranate Juice and POMx pills and liquid supplements. However, the court said one RCT would be sufficient (Also see "Court Upholds FTC Order Against POM, But Scrutinizes Clinical Trial Requirement" - Pink Sheet, 30 Jan, 2015.).

POM Wonderful’s parent firm, Roll Global LLC, on June 1 changed its name to The Wonderful Company, according to a release, to “align the company’s long-standing passion for harvesting healthy and nutritious foods with the consumers it serves across America and the globe.”

Bayer Corp. also is contesting an FTC enforcement with an RCT requirement, arguing that the commission is attempting through litigation to create a regulation requiring clinical trials for supplement structure/function claims (Also see "Bayer Satisfies DoJ ‘Need To Know’ About Probiotic Claim Studies" - Pink Sheet, 23 Mar, 2015.).

The Bayer AG business says the claim that its Philips’ Colon Health probiotic helps defend against occasional constipation, diarrhea, gas and bloating relies on “the totality of scientific evidence in the public domain,” but FTC and the Department of Justice allege that its claims for the product violate a 2007 consent decree that required the firm to substantiate all supplement product claims with competent and reliable scientific evidence.

FTC will conduct its homeopathic regulation workshop at Constitution Center, 400 7th St., SW, in Washington. The deadline is Aug. 1to submit requests to present at the workshop or suggestions for additional topics; the deadline for public comments is Nov. 20.

[Editor's note: Each week, "The Pink Sheet" DAILY features a story from "The Tan Sheet," highlighting a current topic in the consumer medicines or dietary supplements sectors.]