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Belladonna, a toxin also known as deadly nightshade, was an ingredient in homeopathic teething tablets and gels for infants for more than a decade. In 2010, the FDA warned that the amounts of the poison in the treatments fluctuated from item to item. But sales continued, and nearly 400 adverse events were reported (including seizures and deaths of infants) before the major player in the belladonna-teethers market discontinued their product in October 2016.

The unproven, and perhaps dangerous, concoctions that label themselves as “homeopathic” are now the focus of a new FDA crackdown.

“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”

The remedies have been manufactured and distributed without FDA approval since 1988, based on the agency’s guidelines.

The FDA plans to review products, and potentially take regulatory action, based on a priority list. Products with reported safety concerns, those containing pathogens, the ones administered other than orally or topically, products intended to treat life-threatening diseases and conditions, items intended for vulnerable people, and consumer items that do not meet quality or purity standards are the primary focus, the agency said. 

Homeopathy, a concept of medical treatment created at the tail end of the 18th century in Britain, is based on two alternative theories of medicine. First: a substance – even a poison – which causes adverse symptoms in a healthy persons would actually cause benefits in a sick person, if diluted to trace amounts, a concept of “like-cures-like.” Second: the more diluted a substance is, the more potent it becomes, a belief called the “law of infinitesimals.”

From the beginning of the FDA’s history, homeopathy was a player behind the scenes. The 1938 Federal Food, Drug and Cosmetic Act was sponsored in the U.S. Senate by Royal Copeland, a doctor who was a practitioner of homeopathy, according to federal agencies.

The market for the remedies was generally small for most of the 20th century, but belief in alternative medicines has driven the industry to a whopping $3 billion in annual sales currently, according to the FDA. The “large uptick” spans from purported cures and salves for conditions from the common cold to cancer, said Scott Gottlieb, the FDA commissioner.

“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, to contain active ingredients that aren’t adequately tested or disclosed to patients,” said Gottlieb, in a statement today.

The FDA commissioner added that the federal agency was required under its mission to protect public safety, based on the adverse actions reported through the belladonna teething treatments and other consumer products.

“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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