The proposal takes a firmer grip on homeopathic drugs, which are sold in the US
without proof that they are safe and effective, as with formal FDA drug approval. Currently, no homeopathic drugs
"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," FDA Commissioner Dr. Scott Gottlieb said in a statement.
These drugs -- which make up a growing, nearly $3 billion market, the agency said -- claim to treat illnesses using substances that can cause similar symptoms in a healthy person, the FDA cautioned. These may include plants, minerals and even animal excretions. Many scientific studies have found no evidence
that these drugs are effective against cancer, dementia, attention-deficit hyperactivity disorder and a host of other conditions.
The agency said that most homeopathic remedies will not be affected by the newly proposed policy and will remain on shelves. But if the new guidelines become final, the agency will step up enforcement against certain categories of homeopathic drugs it considers to be more risky. These include drugs whose ingredients are potentially toxic or harmful, drugs that are not taken orally or topically, and those marketed to people with life-threatening conditions and "vulnerable populations" like children and the elderly.
The FDA has taken action against specific homeopathic products in the past, including infant teething gels
whose main ingredient, belladonna, was associated with seizures and deaths. An intranasal cold remedy containing zinc was also found to cause a loss of smell
in some users. Other remedies have
contained a toxic substance called strychnine, which is also used as a rat poison in higher doses.
This is not the first time that homeopathic drugs have come under FDA scrutiny. In 2015, it held meetings
at which critics blasted the agency for not taking a strong enough stance on homeopathic treatments. Others defended the products and the current level of FDA oversight.
The Federal Trade Commission also put pressure on over-the-counter homeopathic remedies last year when it announced that it would ramp up scrutiny of their safety and efficacy claims. Under the FTC policy
, which targets "deceptive advertising or labeling," health claims must be based on scientific evidence.
A number of health experts applauded the FDA's proposed crackdown on treatments they view largely as snake oil. However, homeopathic advocates believe that these products can be beneficial and harmless.
The National Center for Homeopathy, a nonprofit based in New Jersey that works with industry partners, said in a statement from its board of directors that it hopes "this action will not impede access" to homeopathic remedies, though the organization said it supports safety and good manufacturing practices.
The FDA is seeking public comments on its proposal for 90 days before putting final touches on the policy.
"We respect that some individuals want to use alternative treatments," Gottlieb said, "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."