The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic.
The agency says it will begin prioritizing enforcement actions against such homeopathic products with reported safety concerns, intended for preventing or treating serious or life-threatening diseases and products aimed at vulnerable populations, among others. However, without new Congressional action, the agency will still not be able to forcibly remove products from the market.
In addition to the new draft guidance, FDA on Monday also released a new warning letter for Canada-based Deserving Health International, which offers a product for ophthalmic use that was manufacturing with non-sterile water and may be contaminated.
Homeopathy is an alternative medical practice dating back to the late 1700s. According to FDA, homeopathy is generally based on two main principles: that a substance that causes symptoms in a healthy person can be used in a diluted form to treat symptoms and illnesses, and that the more diluted the substance, the more potent it is.
Recent years have seen a major uptick in the sale of products labeled as homeopathic. Over the last decade, the homeopathic drug market has grown into a nearly $3 billion behemoth that exposes more patients to potential risks from unproven, untested products and unsubstantiated health claims.
“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,” said FDA Commissioner Scott Gottlieb. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement.”
In September 2016, FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance. The products were associated with serious adverse events, including seizures and deaths in infants and children, and an FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna.
“In the past, these products were mostly prepared by homeopathic physicians for individual patients. Today they are frequently mass manufactured and widely marketed as over-the-counter (OTC) products,” FDA says.
More recently, the agency sought to evaluate whether it might be necessary to update its regulation of homeopathic products and held a public hearing, ultimately determining that it “is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic.”
FDA says the new draft is intended to provide notice that “any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time. FDA is not required, and generally does not expect, to give special notice that a drug product may be subject to enforcement action.”
Although the agency says its intentions are not to remove all homeopathic products from the US market, FDA will take targeted actions.
In terms of which products labeled as homeopathic that will be prioritized for enforcement and regulatory actions, the draft points to the following categories:
- Products with reported safety concerns.
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, products containing an infectious agent with the potential to be pathogenic; a controlled substance; multiple ingredients that when used in combination raise safety concerns; and ingredients that pose potential toxic effects, particularly when they are concentrated or in low dilution presentations or are not adequately controlled in the manufacturing process.
- Products for routes of administration other than oral and topical. For example, unapproved injectables and ophthalmic drugs.
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, or those that “may cause users to delay or discontinue medical treatments that have been found safe and effective through the NDA or BLA approval processes.”
- Products for vulnerable populations, including immuno-compromised individuals, infants and children, the elderly and pregnant women.
- Products deemed adulterated. “For example, if a product purports to be or is represented as a product recognized in an official compendium but its strength, quality, or purity differs from the standards set forth in that official compendium… or if there are significant violations of current good manufacturing practice requirements,” the draft says.
Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry DRAFT GUIDANCE
CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed