OTC Homeopathy Group Revises Label Disclaimers In Light Of FTC Scrutiny
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
American Association of Homeopathic Pharmacists says its new recommended disclaimer for product labels – saying claims are not based on accepted medical evidence – is supported by research showing the language is clear to consumers.
The US homeopathic drug manufacturers association is encouraging members to add a revised optional disclaimer to product labels, packaging and marketing materials that it says increases transparency by stating explicitly that claims are not supported by accepted medical evidence.
The language has already been adopted by the largest firms in the space, Similasan Corp., Standard Homeopathic Co., which markets the Hyland's brand, and Boiron USA, which have added it to products and online materials.
The 35-member American Association of Homeopathic Pharmacists has been working on disclaimer language in response to the Federal Trade Commission's increased scrutiny of homeopathic advertising claims. FTC has honed in on homeopathic products as medical product advertising in recent years shifted from primarily Rx products prescribed for individuals to OTC formulations available to all consumers. Industry concerns were likely heightened by FTC's decision that an earlier voluntary disclaimer was actually misleading to consumers.
Homeopathic firms could also benefit from demonstrating transparency given tighter oversight from FDA, which published a draft guidance in December 2017 that identifies problems it will target for enforcement while allowing the products to remain available without pre-market approval. (Also see "US FDA Moves Homeopathic Drug Enforcement To Risk-Based Approach" - Pink Sheet, 18 Dec, 2017.) AAHP recently submitted comments critical of the draft guidance (see sidebar).
The updated disclaimer states: “Claims based on traditional homeopathic practice. Not accepted medical evidence. Not FDA evaluated.” It replaces a voluntary disclaimer AAHP adopted in 2012: “These statements have not been reviewed by the Food and Drug Administration.” AAHP has asked members to use the new statement “prominently” on packaging as well as on marketing materials “with short production cycles,” such as web pages, online newsletters and digital ads. The new disclaimer was adopted following the association’s August 2017 meeting, though not publicized until recently beyond the association's membership.
The new statement is based partly on an evaluation by a marketing researcher AAHP commissioned in 2017 to study disclaimers. “That research provides manufacturers with a confirmation on what consumers understand from the disclaimer,” the trade group said in a recent release. AAHP says its guidelines are voluntary and do not replace government regulations or non-governmental organizations' standards for advertising claims.
FTC And FDA Review Regulatory Approaches
Homeopathics are available in the US under an FDA 1988 compliance policy guide (CPG) that allows manufacturing and distributing the products without FDA approval. The CPG does not exempt homeopathics from quality standards or from good manufacturing practices requirements, but shifts oversight of those to the Homeopathic Pharmacopeia of the United States.
In November 2016, FTC noted in an enforcement policy statement on marketing claims for OTC homeopathics that the majority were based on theories and not valid studies using current scientific methods to demonstrate efficacy. FTC said that the former AAHP recommended disclaimer, simply stating the products had not been reviewed by FDA, was misleading. (Also see "OTC Homeopathic Labels Must Include Scientific Disclaimers – FTC" - Pink Sheet, 15 Nov, 2016.)
FTC said an OTC homeopathic claim not substantiated by competent and reliable scientific evidence might not be deceptive if a product label effectively communicated: “1) there is no scientific evidence that the product works; and 2) the product claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
AAHP counsel Alvin Lorman said that rather than “contest” FTC’s argument about the previous disclaimer, the trade group “decided to develop and validate, using consumer testing, a new disclaimer.”
Changing labels and packaging in addition to website and ad language is an "expensive proposition" and firms switching to the new disclaimer aren't expected to complete the process by a certain date, said Lorman, a solo attorney in Washington, DC, whose practice includes lengthy experience in homeopathy issues. Additionally, firms will distribute products in new packaging when their stock bearing the old statement sells out.
"We have urged members to update their materials as soon as practicable. It is obviously easier to change advertising and web sites, so I suspect that is being done first. Some homeopathic companies sell many hundred SKUs; adding the disclaimer to all of them will take time. I suspect that most companies are adding the disclaimer to labels as they are reprinted. Remember that it takes a while to sell through product that has already been packaged," he stated.
Reviews of several homeopathic firms' e-commerce sites shows that adding the updated disclaimer to their websites is preceding label and package changes, though the disclaimer has not been added to some web pages for firms' separate brands.
For instance, MediNatura Inc. has added the updated disclaimer to its home page, but not to the separate sites for its brands nor to its product labeling. The Berwyn, Pa., firm markets homeopathic brands BHI, BodyAnew, ClearLfe, ReBoost and T-Relief. (Also see "Industry News Roundup" - Pink Sheet, 9 Sep, 2014.)
Consultant Freddie Ann Hoffman, CEO of HeteroGeneity LLC – a Washington firm that provides strategic and technical assistance in research, development and commercialization of health care products – has suggested FDA might need to end the pass it has allowed on requiring homeopathic claims substantiation . (Also see "FTC Homeopathic Advertising Review Spurs Broader Disclaimer Suggestion, Opens New Stage For RCT Debate" - Pink Sheet, 22 Sep, 2015.) She says the new disclaimer is better, but questioned whether it is enough for FTC. “I believe it is a good thing, having more information on their label to convey to the public what they products are and what they are not,” Hoffman said in an interview.
“An official at FTC may want something a little stronger than that, worded slightly differently. Their concern is that the person on the street who is faced with looking at this probably has no clue what homeopathic is in terms of where it came from and what is traditional homeopathic practice,” she added.
FTC will assess “whether the disclaimer is sufficient and informative and is going to give the public a reasonable amount of information so they can make an educated decision," Hoffman said.
More AAHP Ad Guideline Changes
AAHP included the new disclaimer in its “Consumer Advertising Guidelines for OTC Homeopathic Medicines." Other provisions in the guidelines included:
- “Consumer advertising for non-prescription homeopathic medicines must be truthful and non-deceptive”;
- “Advertisers ... must have homeopathic substantiation for all product claims”
- “An OTC homeopathic medicine shall not be advertised in a manner that suggests that it will prevent or cure a serious disease that requires diagnosis and treatment by a licensed practitioner”;
- “Scientific, consumer or other studies referred to in advertising ... shall represent research performed and interpreted honestly and accurately. In addition, the results or conclusions of such studies should be presented to the consumer honest and accurately.”
Additionally, advertising of an OTC homeopathic medicine “must prominently disclose" its homeopathic status and shall:
- “urge consumer to read and follow label directions”;
- “contain no reference to medical professionals and medical institutions unless such references are truthful, non-misleading and can be substantiated by independent evidence";
- “not include pictures or dramatizations which show ingestion of the medicine, except where it serves to inform consumers as to the proper use or an attribute of the medicine.”
From the editors of the Tan Sheet.