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FDA Moves to Crack Down on Some Homeopathic Drugs

The enforcement plan targets products that could raise risks to patients

Homeopathic Remedies

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The FDA would scrutinize drugs being marketed for cancer, heart disease, and opioid and alcohol addictions.

The Food and Drug Administration (FDA) this week proposed a new enforcement strategy to protect consumers from homeopathic drugs that have the greatest potential to cause risk to patients.

The risk-based approach will “better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions, but where the products have not been shown to offer clinical benefits,” the agency announced. “It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.”

The strategy, outlined in a draft guidance subject to public comment for 90 days, would especially scrutinize drugs being marketed for cancer, heart disease, and opioid and alcohol addictions.

Homeopathy springs from the theory that substances that cause symptoms of a disease can, in small doses, help treat them. But research studies have cast doubt on their effectiveness.

“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,” FDA Commissioner Scott Gottlieb said in a press release.

“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.”

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