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FDA gets aggressive towards homeopathic drugs

19 December 2017

He cautioned that product makers are likely to "hit back hard with lots of spurious claims in an effort to confuse consumers and to protect their profits".

He added, "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".

The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic.

Since the late 1700s, homeopathy has been based on two main principles, according to the FDA.

Over the past several years, the FDA has issued warnings about other homeopathic drug products, including zinc-containing intranasal products that may cause a loss of sense of smell; certain homeopathic asthma products that have not been effective in treating asthma and other products that contain strychnine, a poison used to kill rodents.

18, 2017 The U.S. government plans to crack down on unproven homeopathic remedies, particularly those that pose the greatest risk to patients.

Over the last decade, the homeopathic drug market has grown exponentially, resulting in a almost $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.

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Consumer advocates said the FDA plan makes sense for products that are mostly harmless, but can be risky if manufacturers stray from traditional ingredients, dosing and manufacturing.

FDA enforcement authorities will focus on: products with reported safety concerns; products that contain or claim to contain ingredients that are associated with potentially significant safety concerns; products administered in ways other than orally and topically; products meant to prevent or treat serious or life-threatening diseases and conditions; products for vulnerable populations; products that do not meet standard of quality, strength or purity as required under the law. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don't meet current good manufacturing practices. "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".

For instance, in 2016 the FDA warned consumers about the risks of homeopathic teething tablets after they were tied to seizures and deaths in infants. FDA testing later confirmed the products contained high levels of belladonna, also called nightshade, a poisonous herb that has always been used at low dosages in homeopathic medicine. "Today they are frequently mass manufactured and widely marketed as over-the-counter (OTC) products", FDA says.

Products for routes of administration other than oral and topical.

The FDA hasn't updated its regulations for homeopathic medicine since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients on product labels.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding as any other drug product.

The FDA will open its proposal to public comments for 90 days before issuing its final policy.