Public health concerns should prompt FDA to tighten its regulation of homeopathic drugs, a citizen petition filed by the nonprofit Center for Inquiry says.

The group, which advocates for scientific evaluation of consumer goods and services, submitted a petition Aug. 26 asking FDA to initiate a rulemaking to require homeopathic products meet standards of effectiveness set for nonprescription pharmaceuticals, and when homeopathics fail to meet those standards, require a label disclaimer that FDA has not evaluated a product’s quality, safety or efficacy.

The petition argues that FDA’s “permissive regulatory policy has enabled the growth of a multi-million dollar market for products for which there is no credible scientific evidence of effectiveness beyond what is expected from the placebo effect.”

The center points to market research stating consumer sales of homeopathics in the U.S. reached $870 million in 2009, and a Centers for Disease Control and Prevention survey showing roughly 3.9 million U.S. adults and 900,000 children used the products in 2006.

Ronald Lindsay, president and CEO of the Amherst, N.Y.-based center, said the homeopathic market’s growth supports the argument that the products represent a potential public health issue.

“This is not something that is just some little sideshow somewhere,” Lindsay said in an interview. “The market is such a size now that we think the FDA would be ignoring its responsibility unless it did something here,” he added.

FDA’s compliance policy guide for homeopathics also notes the increase in sales. The guide says homeopathics “historically have borne little or no labeling for the consumer” because of the relatively limited manufacturing and marketing of the products.

However, FDA notes the U.S. market has grown to a multimillion dollar industry, “with a significant increase shown in the importation and domestic marketing of homeopathic drug products.”

Warnings Underscore Risk

The Center for Inquiry also cites 2009 FDA and Federal Trade Commission enforcement actions against retailers and manufacturers making unapproved drug claims for homeopathics, nutritional supplements and other products and devices about preventing or treating the H1N1 flu virus (Also see "FTC Stakes New Territory, Joins FDA In Warning On H1N1 Claims" - Pink Sheet, 19 October, 2009.).

Lindsay said some consumers likely will turn to homeopathics when concerned about any seasonal flu.

“Our position would be that … some of those people, based on health surveys, are taking homeopathic drugs and it may have a serious effect, perhaps a life-threatening affect on their health,” Lindsay said.

The center is aware, though, of the relatively low priority FDA gives to regulation of homeopathics and that a mid-1990s citizen petition making similar requests did not prompt action by the agency.

While FDA does not require homeopathic products to prove efficacy, the agency’s compliance guide notes they must conform to the non-governmental Homeopathic Pharmacopoeia of the United States.

The homeopathic market “is such a size now that we think the FDA would be ignoring its responsibility unless it did something here.” – Center for Inquiry CEO Ronald Lindsay

Traditional pharmaceuticals must meet standards set by the U.S. Pharmacopeia, but FDA’s pre-market approval is required for Rx and nonprescription drugs, with some OTC products allowed for sale through compliance with monographs rather than through applications to the agency.

The American Association of Homeopathic Pharmacists argues homeopathic drugs have a long history of safe use and FDA’s compliance guide “more than adequately protects the public.”

AAHP President Mark Land noted FDA has yet to complete the OTC drug review that began in 1972, when the agency said it would review homeopathic drugs in a separate process.

“Homeopathic drugs have not been ignored by FDA. Rather, the agency has made a risk-based decision to first focus on the drug review of allopathic drugs,” Land said in an email.

Land, a VP at Newtown Square, Pa.-based homeopathic firm Boiron, added that FDA noted homeopathics’ “uniqueness” in deciding to evaluate the products separately.

“We agree that any evaluation of their use must be conducted within the context of their ‘uniqueness,’” he said.

Members Help Drive Petition

For the Center for Inquiry, supporters’ concerns about homeopathics helped prompt the petition, the first the center has made to a federal agency.

“Frankly, we’re an organization that relies on public support. A lot of our donors who are interested in this area have said to us, ‘You should do something,’” Lindsay said.

“We wanted to take some action. We feel that given the circumstances it wasn’t completely futile. If we thought there was a 100% chance it was just going to be ignored, we wouldn’t have done it,” he added.

In the event FDA rejects the requests made in the petition, the center could opt to appeal the agency’s decision in court.

Lindsay said the center is “hopeful that maybe circumstances have changed” since FDA failed to act on the 1990s homeopathics petition, “and it’s possible that the FDA now will actually treat the petition seriously.”

“Failing that, if in fact they do deny it, we may go to court over the denial.”

However, if FDA does not respond to the petition, the center could not appeal in court. And so far, the center has not been approached to represent a consumer who wants to file a claim against a homeopathic manufacturer alleging false advertising or other damage.

“You just can’t manufacture it. You have to find the right plaintiff,” Lindsay said.

Recently, a federal judge in California rejected Boiron’s argument that FDA’s regulation of homeopathic drugs pre-empts a state consumer protection law. The plaintiff originally brought the complaint under state law, arguing Boiron’s Children’s Coldcalm pellets were ineffective for relief of cold symptoms (Also see "FDA Regulation Of Homeopathics Does Not Pre-empt Damages Claims – Court" - Pink Sheet, 15 August, 2011.).

In a second California case filed in state court in August, a plaintiff alleges Boiron falsely advertised its Oscillococcinum product “has the ability to cure the flu,” but that the product “is nothing more than a sugar pill.”

Lindsay said such claims, combined with published research on homeopathics’ efficacy, also prompted the center’s petitions.

“The science is clear – it really doesn’t have an effect. If the FDA actually required, because they are drug manufacturers, to provide proof that the drug actually was effective, they couldn’t do it,” he said.

Petitions Argue For Boiron Warnings

Lindsay’s group also submitted two petitions asking FDA to submit warnings to Boiron.

One petition argues that “misleading advertising” on a website for Oscillococcinum implies that the product is FDA tested and approved, and the second requests ordering the firm to print the contents of the product in English, which would be “extract of Muscovy Duck liver and heart,” rather than in Latin.

These requests likely will not prompt FDA action as the agency has said that citizen petitions are not an appropriate venue to elicit enforcement actions (Also see "Citizen Petitions Are No Place To Request Enforcement Action - FDA" - Pink Sheet, 16 August, 2010.).

A Boiron spokeswoman said the petitioners “ignore the well established framework of FDA regulations and quality standards applicable to homeopathic medicines."

Boiron says the petitioners also ignore scientific support for homeopathics in general and, “specifically with regard to Oscillococcinum,” published, double-blind, placebo-controlled randomized clinical studies demonstrating product efficacy.

In an email, the spokeswoman said the studies show Oscillococcinum shortens both the severity and duration of flu-like symptoms.

By Malcolm Spicer

Science-Based Evaluation Advocates Want Tighter Homeopathic Oversight

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