FDA Considers Overhauling Its Regulation of Homeopathic Products for the First Time in 25 Years, by Elisabeth Ulmer
On March 27, 2015, the Food and Drug Administration (“FDA”) posted a notice of public hearing and request for comments about “the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products.” The FDA took this action because the previously limited homeopathic drug market is currently a multimillion-dollar industry in the United States and because this growth has highlighted increased safety and quality concerns.
The FDA held the public hearing on April 20-21, 2015, in Maryland, at which stakeholders provided comments on the current state of how homeopathic products are used and how the FDA regulates them. Advocates of homeopathy argued that these products should be regulated less, while skeptics contended that they should be regulated more. On June 10th, the FDA then extended the comment period to August 21st. The Federal Register shows that a total of more than 8.500 comments were submitted.
The FDA’s 1988 Compliance Policy Guide (“CPG”) contains the FDA’s regulatory policies for homeopathic products. The CPG defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (“HPUS”), an addendum to it, or its supplements.” The Homeopathic Pharmacopœia Convention of the United States (“HPCUS”), which first produced the HPUS in 1897, decides what qualifies as an officially monographed homeopathic ingredient. The HPUS contains over 1200 officially monographed homeopathic ingredients and, along with the United States Pharmacopoeia, is an official compendium that is recognized by the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and that sets standards for the naming, quality, and labeling of drug products.
The active and inactive ingredients in these drugs can include plants, healthy or diseased animal or human sources, minerals, and chemicals. When homeopathic drugs are used in treatment for “serious disease conditions,” licensed practitioners must dispense them. However, any homeopathic drug that is “offered for use in self-limiting conditions recognizable by consumers” can be sold over-the-counter (“OTC”). According to the Centers for Disease Control and Prevention’s National Center for Health Statistics, adult consumers spent about $2.9 billion on homeopathic medicine in 2007.
Homeopathic products, as with all other drugs that meet the definition of a “drug” or a “biological product,” are regulated under the FD&C Act and are subject to its rules on approval, labeling, adulteration, and misbranding. In its Federal Register Notice, the FDA stated that, pursuant to section 201(p) of the FD&C Act, homeopathic drugs must also meet “the same premarket approval requirements and the same standards for safety and efficacy” as all new drugs before being sold.
However, since 1988, homeopathic drugs have been made and sold without FDA approval. The FDA also referenced the 2012 American Association of Poison Control Center Annual Report, which showed 10,311 reported poison exposure cases related to “Homeopathic Agents.” In 1972, the FDA conducted the OTC Drug Review to determine which OTC drugs are recognized as safe and effective by qualified experts, but given the “uniqueness” of homeopathic medicine, the FDA decided to review the safety and effectiveness of these drugs at a later time. To date, this category has not been reviewed.
Federal Trade Commission (“FTC”) staff further noted in a comment that current FDA and FTC policies conflict regarding homeopathic products. The FDA does not require that homeopathic products have its approval or general recognition as being safe and effective if other conditions are met, such as including an indication for use on the label. The FDA does require the inclusion of indications for use, but it does not require advertisers to substantiate these claims with evidence. On the other hand, FTC policy requires that all “health, safety, or efficacy” claims in advertising must be supported by “competent and reliable” scientific evidence. FTC staff expressed their concerns that these two differing policies may harm consumers and confuse advertisers. The latter may believe that if the homeopathic product complies with FDA policy, it does not need to comply with the stricter FTC policy.
The comment by FTC staff also discussed research done by the FTC’s Division of Advertising Practices. The findings showed that consumers did not understand how homeopathic products work, how they are regulated, or how their effectiveness can be evaluated. The FTC has announced that it will host a September workshop on Monday, September 21, 2015, in Washington, D.C. to examine the science behind, regulation of, and advertising for homeopathic products. Interested parties are invited to submit comments by any of the following methods:
Submit electronically at: https://ftcpublic.commentworks.com/ftc/homeopathyworkshop/
Send to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, D.C. 20580
Deliver to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, D.C. 20024
All hard copy submissions should reference the Homeopathic Medicine & Advertising Workshop, both in the text and on the envelope. Comments are due on Friday, November 20, 2015.