The Food and Drug Administration on Monday released a draft guidance (PDF) that will boost enforcement of manufacturing, marketing, and safety regulations for homeopathic products.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.