Dec. 18. 2017 -- The FDA is adopting a more aggressive stance when it comes to regulating homeopathic remedies.
The agency says it will focus its enforcement efforts on products that are especially risky because of who they’re meant to treat, how they’re given, what they contain or whether or not there have been reports of safety problems about them.
In draft guidelines issued today, the FDA says it will concentrate on products that have:
- Reported safety concerns.
- Potentially dangerous ingredients.
- More risk because of how they’re given — for example, through an injection or eye drop as opposed to being rubbed on the skin or swallowed.
- Ingredients that are not listed on the label .
- More risk because they are intended to treat vulnerable individuals, like children or the elderly.
- More risk because they are meant to treat a serious or life-threatening condition.
Homeopathic medicines are based on the idea that symptoms can be treated with highly diluted amounts of active ingredients. The FDA does not review homeopathic products for safety or effectiveness before they are available to consumers.
In a call to reporters explaining the changes, FDA officials said they were taking the action because the agency had struggled in the past to protect consumers against homeopathic products that were known to be dangerous — including homeopathic teething tablets for babies.
In January, FDA testing found varying amounts of belladonna — an herb that can be toxic—in Hyland’s teething tablets. The FDA strongly warned consumers not to purchase the product, but it remained on the market because the company initially refused to conduct a recall, saying that the FDA had not established a scientific link between its products and seizures and deaths in children.
Hyland’s did recall their teething tablets in April 2017, and has stopped distributing them in the U.S.
FDA Commissioner Scott Gottlieb, MD, said the changes were necessary because the market for homeopathic products had grown into a $3 billion-a-year industry, and the agency’s previous regulatory stance had been viewed as a “perceived safe harbor.” Previously, the agency only took action against dangerous homeopathic products when they fail certain standards called good manufacturing practices.
“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,” he said.
“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,” Gottlieb said.
In November of 2016, the Federal Trade Commission also announced that it would take a tougher position on health claims made by homeopathic products.
Interested parties will have 90 days to comment on the proposed guidelines.