The Food and Drug Administration on Monday released a draft guidance (PDF) that will boost enforcement of manufacturing, marketing, and safety regulations for homeopathic products. The agency plans to specifically target what it considers high-risk products, such as those known to contain dangerous substances or are intended to be used for treating serious or life-threatening conditions.

Homeopaths, meanwhile, told Ars in a relatively subdued statement that they welcome the FDA’s efforts but are “hopeful that this action will not impede access.”

The FDA’s move follows a string of high-profile safety issues with homeopathic products. That includes a years-long investigation by the agency that linked illnesses in 400 infants and the deaths of 10 babies to improperly manufactured homeopathic teething products. In that case, FDA investigators confirmed that the products contained variable and sometimes high levels of toxic belladonna, aka deadly nightshade, which can have harmful and unpredictable effects in infants. With strong-arming, the FDA got the manufacturer, Hyland’s, to recall the products earlier this year

In its announcement Monday, the FDA said that it “continues to find that some homeopathic drugs are manufactured with active ingredients that can create health risks while delivering no proven medical benefits.”

Concentrated regulation

Homeopathy is a centuries-old practice based on unscientific notions that if a substance—say a toxic chemical—can produce the same symptoms of an illness, it can be used to cure that illness (“like cures like”). But, homeopaths believe that the more diluted a substance, the more potent (“law of infinitesimals”), so many of their remedies are heavily diluted, often to the point where they only contain water. Some homeopaths believe that water molecules can even have “memory” of the substance.

As such, many of these products are harmless, offering nothing more than hydration and the placebo effect. And, although homeopathic products are subject to the same regulation as other drugs, in 1988 the FDA issued a compliance policy that essentially diluted enforcement.

But, with a now-booming, $3 billion homeopathy industry, it’s time to rethink enforcement, according to FDA Commissioner Scott Gottlieb. In a media statement Monday, Gottlieb said:

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients… Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”

Products with known safety issues

Products said/known to contain a dangerous substance, such as belladonna

Products intended to be administered not by an oral or topical route, such as an injection or eye drop

Products intended to treat serious or life-threatening conditions and diseases, which may dangerously replace effective, standard treatments

Products for vulnerable populations, such as infants and the elderly

Products found to be adulterated

The draft guidance issued Monday lays out a risk-based approach to tackling the homeopathic industry. The agency identified six categories of homeopathic products that have “the greatest potential to cause risk to patients” and will therefore be primarily in the agency’s crosshairs. They include:

The FDA acknowledged that many homeopathic products will fall outside of these categories, a point that may bring some relief to homeopaths.

In an emailed statement to Ars, the National Center for Homeopathy’s board of directors responded to the FDA’s actions, saying:

The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.

The statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “ arbitrary and capricious .” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs]. The NCH called on homeopaths to fight misconceptions about homeopathy at the time.

The public will have 90 days to comment on the FDA’s draft guidance to boost enforcement of homeopathic products. But the agency seemed resolute in stepping up enforcement, noting in its announcement that it will “consider taking additional enforcement and/or regulatory actions” considering its concern over the products. When the guidance is finalized, the agency will simultaneously withdraw the lax 1988 compliance policy.