Hit Piece: The FDA Might Finally Crack Down on Homeopathy

 BLOOMBERG

Historically, regulators have generally looked the other way. That stance may be poised to change: The Food and Drug Administration (FDA) is this week holding a public meeting to evaluate “whether and how to adjust the current enforcement policies” to keep up with the growing homeopathic industry and a corresponding increase in safety problems. Since 2009, the FDA has sent nearly 40 warning notices to homeopathic manufacturers and has overseen three recalls. Pulled products include zinc cold remedies that caused people to lose their sense of smell and “teething tablets” with toxic levels of the plant belladonna.

About 3.3 million Americans spent $2.9 billion on homeopathic treatments in 2007, according to the latest estimates from the Centers for Disease Control (CDC), though private industry research suggests a smaller market. The industry has “mushroomed” since the early 1980s, when homeopathic sales were just $1.5 million a year, says Bill Nychis, who worked at the FDA for 39 years in compliance and enforcement. At the time, the agency was midway through a decades-long process reviewing older over-the-counter drugs for safety and efficacy. The FDA had the authority to regulate homeopathic remedies, but because sales were so small, the agency opted to outsource much of that job to the industry itself. “Risk is always depending upon the number of products on the market and the sales volume of the products,” says Nychis, who now advises importers at FDAImports.com.

In 1988, the FDA issued a policy guide “where we basically allow these drugs to come to the market without premarket approval,” says Cynthia Schnedar, director of compliance for the agency’s Center for Drug Evaluation and Research. Federal regulators allow the sale of any substance listed in the Homeopathic Pharmacopeia, a document published since the 1800s and maintained by a nonprofit industry association. The remedies need to meet certain FDA manufacturing guidelines and can be marketed over the counter only for “self-limiting” conditions, meaning illnesses like colds that go away on their own.

Schnedar acknowledges it’s time for the FDA to reevaluate that policy. “We’ve seen a huge expansion of the market and we’ve also seen some emerging safety and quality issues,”she says. A panel of nine FDA officials, including lawyers, a pediatric ethicist, and the director of the over-the-counter drugs division, will hear “from people on all sides of this question,” Schnedar says. She wouldn’t elaborate on changes the FDA is considering, but in its notice about the sessions, the agency said it would seek data about the risks and benefits of homeopathic products, recommendations on regulatory processes, and would look into whether consumers “have adequate information to make informed decisions” about such remedies.

READ MORE…