The Food and Drug Administration wants to toughen its regulation of homeopathic drugs.
It plans to do so by cracking down on products with the greatest safety risk.
The new measures were unveiled last month in an announcement by the federal agency.
The market for homeopathic drugs has grown exponentially over the past decade into a $3 billion industry.
In the process, untested products and unsubstantiated health claims have proliferated, according to the Food and Drug Administration (FDA).
“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,” said FDA Commissioner Dr. Scott Gottlieb.
“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 the FDA announcement.
In the past decade, the FDA has warned against the use of several homeopathic products, including teething tablets and gels containing belladonna, a toxic plant derivative.
The agency has also issued cautionary notices for zinc-containing nasal sprays that may cause a loss of smell; ineffective asthma treatments; and various products found to contain the highly toxic poison strychnine.
What is homeopathy?
Homeopathy dates to the 18th century and is based on two ideas.
One is that a substance that causes symptoms in a healthy person can be used, in diluted form, to treat a sick person.
The other is that the substance’s potency increases with greater dilution.
For instance, a homeopathic remedy for the watering eyes and runny nose of a cold might contain a microdose of red onion.
Homeopathic remedies are derived from minerals, plants, chemicals, and human and animal secretions and excretions, such as snake venom, and are marketed as “all natural.”
However, critics charge that there is no scientific basis for homeopathy and that some products can be dangerous.
By law, homeopathic drug products are subject to the same approval, purity, and branding requirements as all other drugs.
But under a 1988 enforcement policy, the FDA has allowed prescription homeopathic drugs to be manufactured and sold without FDA approval, and for over-the-counter homeopathic remedies to be made and sold without a determination that they are generally recognized as safe and effective.
Mixed reaction to FDA proposal
The FDA is proposing that it begin actively regulating homeopathic drugs using a risk-based approach, focusing its enforcement efforts on products that:
- have reported safety concerns or ingredients that raise safety concerns
- are injected
- are intended for serious or life-threatening diseases and conditions, such as cancer and heart disease
- are intended for vulnerable populations, such as children
- fail legal standards for quality, strength, or purity
The new policy would allow the agency to pull products from the market that it considers a health threat.
However, the agency expects that many homeopathic products will fall outside these categories and will remain available to consumers.
Homeopathic organizations reacted positively to the FDA proposal.
The National Center for Homeopathy, an advocacy group, said in a statement that it “supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry” and that it is “hopeful that this action will not impede access” to homeopathic medicines.
The American Association of Homeopathic Pharmacists, a trade organization for homeopathic manufacturers, marketers, and pharmacists, “applauds the Agency’s plan to take quick action against illegal or unsafe homeopathic medicines,” according to its statement.
Critics of homeopathy also welcomed the FDA’s proposal, but some said it doesn’t go far enough.
“Now that the market for homeopathic products has exploded — thanks in part to lax FDA oversight — the FDA realizes it has to do its job,” Dr. Steven Novella, a neurologist at the Yale School of Medicine, wrote on Science-Based Medicine, a website that uses scientific principles to evaluate alternative medicine.
“Of course, if they adopt these guidelines, the real test is how they will be enforced,” said Novella.
Novella is concerned that the FDA will simply send warning letters to producers of high-risk homeopathic products to change the product or its marketing so that they are no longer considered high-risk.
Instead, Novella would like to see the FDA systematically take all homeopathic products off the market.
“That would be completely appropriate, and in fact anything less is a dereliction of duty, in my opinion,” said Novella, who called homeopathic products “all 100% worthless.”
A few years ago, the National Health and Medical Research Council in Australia took a hard look at more than 1,800 research papers on homeopathy, of which 225 met the government agency’s criteria to be included in an examination of homeopathy’s efficacy.
After completing its examination in 2015, the agency concluded that “there is no good quality evidence to support the claim that homeopathy is effective in treating health conditions.”
The FDA proposal is open for public comment until early March.