Will FDA change the way it regulates homeopathic drugs? Should it?

Will FDA change the way it regulates homeopathic drugs? Should it?

Since I wrote my first article on the regulation of homeopathic products nine years ago, not much has changed. But change may be coming.

Walking down the dietary supplement aisles at Expo West, passing all of the products claiming to “support” and “promote” various body functions and general health, every now and then I see a product that claims to treat or prevent some ailment, which generally a supplement cannot claim to do. So how can they say that? Then I look closer at the product label and see the word “homeopathic.” Ah-ha. That’s how.

It’s been nine years since I wrote my first article on the regulation of homeopathic products by the FDA, FTC and the National Advertising Division (NAD). In that article, I explained homeopathy’s historical roots (Samuel Hahnemann, Sen. Copeland) and principles (“like cures like," “law of similars,” dilution), as well as the approach taken by the NAD and FTC (generally substantiation is needed for product claims). I also discussed FDA regulation of the products, which is essentially that they are treated as drug products except that they do not need to be approved if they meet certain criteria set out in a Compliance Policy Guide (CPG).

Since that article nine years ago, not much has changed. Sure, there have been some additional enforcement actions, such as FDA’s 2009 Warning Letter to Matrixx Initiatives about its homeopathic product Zicam. But things, generally, including FDA’s policy on homeopathic products as stated in the CPG, remain the same. However, that may be changing.

On March 27, 2015, FDA announced that it will be holding a public hearing titled: “Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century.” The hearing will be at FDA in Maryland April 20-21.

In the announcement of the hearing, FDA explained that the homeopathic industry has grown from a “multimillion” dollar industry when the CPG was first issued in 1988 to an estimated $2.9 billion industry in 2007. It is even larger now. FDA noted that, “many drugs labeled as homeopathic are sold OTC in major retail stores and are often marketed as natural, safe and effective alternatives to other prescription and nonprescription products.” It then stated that it has received reports of negative health effects from homeopathic drugs (as of course it does for all types of products it regulates).

At the hearing, FDA wants to get input on its regulation of homeopathic products from consumers, patients, caregivers, health-care professionals, patient groups and industry. Specific topics it would like to learn about include:

  • What are consumer and health care provider attitudes towards homeopathic products?
  • Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives?
  • Are there areas of the current CPG that could benefit from additional clarity?
  • Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
  • What would be an appropriate regulatory process for evaluating whether a product is appropriate for OTC (rather than prescription) use?

Stay tuned.

Will FDA change its regulatory approach to homeopathic products? Should it? Would FTC follow suit?

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