Consumer Advertising and Labeling Guideline for Over-the-Counter Homeopathic Medicines
Adopted August 22, 2012
Revised August 29, 2017
Introduction
Homeopathic medicines play an increasing role in self-medication among American consumers. Homeopathic products sold at retail provide consumers with access to low cost, safe medications, and they are routinely marketed to consumers on retail shelves among other well known OTC products.
Homeopathic medicines have been classified as drugs by the Federal Food, Drug, and Cosmetic Act (FDCA) since 1938 and are regulated as such by the Food and Drug Administration (FDA). The regulatory framework works well and, as a result, homeopathic medicines have enjoyed a long history of safe use.
Advertising for all OTC drugs is subject to regulation by the Federal Trade Commission.
This guideline sets forth the labeling and advertising requirements with which members of the American Association of Homeopathic Pharmacists are expected to adhere to in the marketing of OTC homeopathic drugs. Advertising and labeling of prescription homeopathic drugs are not within the scope of this guideline.
Guideline Provisions
1. Consumer advertising for non-prescription homeopathic medicines must be truthful and non-deceptive.
2. Advertisers of OTC homeopathic medicines must have homeopathic substantiation for all product claims (see FDA Compliance Policy Guide 400.400).
3. 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.
4. Scientific, consumer or other studies referred to in advertising of an OTC homeopathic medicine shall represent research performed and interpreted honestly and accurately. In addition, the results or conclusions of such studies should be presented to the consumer honestly and accurately.
5. Advertising of an OTC homeopathic medicine shall urge consumers to read and follow label directions.
6. Advertising for an OTC homeopathic medicine shall contain no reference to medical professionals and medical institutions unless such references are truthful, non-misleading, and can be substantiated by independent evidence.
7. Advertising of an OTC homeopathic medicine shall 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.
8. Advertising, labels, and labeling for an OTC homeopathic drug must prominently disclose the homeopathic status of the product.
9. Advertising to consumers for an OTC homeopathic drug and labels and labeling of such drugs shall prominently include the following statement in connection with claims for the product:
"Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.”
The Federal Trade Commission’s views on the necessary prominence for this disclosure can be found at 81 Fed. Reg. 90123 (Dec. 13, 2016).
10. The disclaimer in Paragraph 9 does not apply to the advertising, label, and labeling of any homeopathic OTC product for which the sponsor possesses competent and reliable scientific evidence.
Procedures
Complaints under the AAHP voluntary guidelines may be resolved in various ways, including informally by discussing the complaint with the advertiser directly, notification to the advertiser in writing, or by submission to the Food and Drug Administration, the Federal Trade Commission or the Council of Better Business Bureau’s (CBBB) National Advertising Division under its procedures.
AAHP voluntary guidelines do not replace other governmental or non-governmental systems regulating advertising claims. Rather, AAHP’s guidelines seek to encourage voluntary compliance with industry standards