The homeopathic drug market has grown exponentially in the past 10 years, becoming the nearly $3 billion industry that it is today. That, in turn, has drawn the scrutiny of the FDA, which recently proposed new draft guidance(www.regulations.gov) that calls for a risk-based enforcement approach to drug products labeled as homeopathic.
That's according to a Dec. 18 news release from the agency,(www.fda.gov) which has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. Additionally, the release notes, FDA officials have observed a rising number of poorly manufactured homeopathic products that contain potentially dangerous amounts of active ingredients.
The 1938 Food, Drug and Cosmetic Act officially recognized the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements; accordingly, homeopathic drug products historically have been subject to the same regulatory requirements as all other drug products.
Recognizing the growing market for these products, however, the FDA in 1988 created specific enforcement policies(www.fda.gov) governing the manufacture and distribution of prescription and nonprescription drugs labeled as homeopathic without FDA approval.
- The FDA has proposed new draft guidance for a risk-based enforcement approach to regulating drug products labeled as homeopathic.
- The FDA's draft guidance lays out the agency's proposed plan to prioritize enforcement and regulatory actions for unapproved homeopathic drug products that have the greatest potential risk for consumers.
- It should be noted that per this draft guidance, many homeopathic products that don't fall under the proposed risk-based categories will remain available to consumers.
The new proposal updates the FDA's existing policy to focus on better regulating homeopathic treatments that are marketed to treat serious diseases and/or conditions but that don't demonstrate proven clinical benefits. The draft guidance also addresses situations where products labeled as homeopathic contain potentially harmful ingredients or don't meet current good manufacturing practices.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," said FDA Commissioner Scott Gottlieb, M.D., in the news release. "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.
"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. 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."
Draft Guidance Details
The FDA's draft guidance lays out the agency's proposed plan to prioritize enforcement and regulatory actions for unapproved drug products labeled as homeopathic that have the greatest potential risk for consumers.
Thus, the FDA will focus its enforcement authorities on products
- with reported safety concerns;
- that contain or claim to contain ingredients associated with potentially significant safety concerns;
- that are administered via routes other than oral or topical;
- that are intended to be used to prevent or treat serious and/or life-threatening diseases and conditions;
- that target vulnerable populations; and
- that don't meet standards of quality, strength or purity as required under the law.
Specific products that could be subject to enforcement priority under the draft guidance include infants' and children's products labeled as containing ingredients associated with potentially significant safety concerns, such as belladonna and Nux vomica, as well as those marketed for serious health conditions, such as cancer and heart disease.
It should be noted that per this draft guidance, many homeopathic products that don't fall under the proposed risk-based categories will remain available to consumers.
The agency is accepting comments on its draft guidance(www.regulations.gov) until 11:59 p.m. ET on March 20, in addition to examining how it is implementing its current compliance policy.
The FDA joins the Federal Trade Commission (FTC) in re-examining its approach to homeopathic drugs. In November 2016, the FTC announced a new enforcement policy(www.ftc.gov) for OTC homeopathic drugs. The FTC said it would hold homeopathic drug manufacturers to the same standards as those that produce other health products when it comes to proving efficacy and safety of their products with scientific evidence.
FDA Track Record
The FDA has a longstanding history of voicing specific concerns about homeopathic drug products. In an Oct. 23, 2010, news release, for example, the agency warned consumers to not use Hyland's Teething Tablets(wayback.archive-it.org) because the products were found to contain varying amounts of belladonna. An FDA inspection of the product's manufacturing facility revealed substandard manufacturing controls.
On Sept. 30, 2016, the FDA again warned against the use of homeopathic teething tablets and gels(www.fda.gov) after finding the products were associated with serious adverse events, including seizures and deaths, in infants and children. Subsequent FDA lab analysis confirmed(www.fda.gov) certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna.
The FDA also has issued warnings about other homeopathic drugs in the past several years, including
- certain zinc-containing intranasal products(wayback.archive-it.org) that could cause anosmia;
- OTC homeopathic asthma products(wayback.archive-it.org) that weren't shown to be effective in treating asthma; and
- various homeopathic drug products(www.fda.gov) labeled as containing potentially toxic ingredients, including N. vomica, which contains strychnine.
"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, M.D., director of the FDA's Center for Drug Evaluation and Research, in the agency's recent news release. "The draft guidance is an important step forward in the agency's work to protect patients from unproven and potentially dangerous products."
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