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FDA Considering Changes to Homeopathic Drug Regulation

The U.S. Food and Drug Administration (FDA) is hosting a two-day public hearing to discuss whether its current regulations for homeopathic drugs are adequate or need to be changed.  The first half of the hearing took place yesterday, April 20, 2014, and the second half will take place today.

FDA does not currently review drugs labeled as homeopathic for safety and efficacy.  In CPG 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”, it states that drugs “labeled and offered for sale as a homeopathic drug… shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States and not to those of the United States Pharmacopeia.”

What is a homeopathic drug?

CPG 4oo.4oo defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.”  Homeopathy is based on the belief that small doses of substances that cause symptoms in healthy people can cure comparable symptoms in sick people.  These substances are diluted anywhere from 1/10 to 1/50,000 or higher before being added to homeopathic drug products.

Why change the regulations now?

FDA’s potential reconsideration of its homeopathic drug regulations stems from the recent growth of the homeopathic industry.  In CPG 400.400, FDA says that until recently, the homeopathic drug industry consisted of only a few manufacturers with limited patients.  The homeopathic drug market has now grown into a multimillion dollar industry in the United States.  According to FDA’s Notice of Public Hearing, over 500 new ingredient monographs have been added to the HPUS since 2004.

Along with the growth in industry, adverse effects of homeopathic drugs have been reported to FDA, and the 2012 American Association of Poison Control Center Annual Report showed that there were 10,311 poison exposure cases related to “homeopathic agents”, 697 of which led to treatment in a health care facility.

Comments from the Public Hearing

Some of yesterday’s speakers believed that FDA should update its regulations to be stricter on homeopathic drugs, while some believed that FDA’s current regulations are already sufficient.

Adriane Fugh-Berman from the Georgetown University Medical Center expressed concern that allowing homoeopathic drugs to sit alongside conventional OTC drugs on store shelves could be misleading to consumers.  She said that the average consumer does not know the difference between the two types of drugs, and therefore may believe that FDA has reviewed the homeopathic drugs for safety and efficacy.  She also noted that the average consumer doesn’t understand homeopathic dilution formats (which are an acceptable ingredient quantity indicator under CPG 400.400), so they cannot easily understand the amount of certain ingredients that a homeopathic drug contains.

Among other things, Fugh-Berman proposed that FDA require all active ingredients to be listed with modern scientific language and require ingredient quantities to be expressed in standard scientific format.  She also strongly recommended that if FDA decides to continue to delay its regulatory oversight that they indicate this on OTC homeopathic drug labels.

Michael DeDora from the Center for Inquiry agreed that current homeopathic drug regulations may be misleading to consumers.  He noted that recent findings released by the Australian National Health in Medical Research Council concluded that there are no health conditions for which there is reliable evidence that homeopathy is effective. DeDora said that homeopathy can endanger consumers who choose to rely on homeopathy remedies for certain health conditions instead of other treatments with proven effectiveness.  He said that his company believes in freedom of choice, but added that they “also believe that true freedom of choice is impossible unless one is fully informed on the choices.”

Amy Rothenberg from the American Association of Naturopathic Physicians said that she did not seek change in FDA regulation of homeopathic drugs, but rather clarification, enforcement, and closer working relationships between the FDA and the homeopathic drug industry. “For me personally, with decades of teaching and practicing and providing care for many thousands of patients within my practice for all these years, I have not seen adverse effects,” she said.

Instead of changing the regulations for homeopathic drugs, Rothenberg wants FDA to be clearer about what is considered a homeopathic drug.  She said that her company agrees with FDA that drugs with only one or a few homeopathic ingredients mixed with conventional active ingredients should not be labeled as homeopathic.  They also urge that no homeopathic products be labeled with life-threatening diseases.

Bruce H. Shelton from the Arizona Homeopathic and Integrative Medical Association also feels that FDA’s current regulations are sufficient. “We found in our research that no major organization, country, or government in the world has determined that homeopathy is not safe,” he said.  Shelton stated that in his 25 years of practice he has had very few adverse events reported, and homeopathic remedies have helped his patients in situations where conventional remedies have failed them.

These are only a few of the opinions expressed during FDA’s public hearing, and the  public hearing comments accompany over 1,000 electronically-submitted comments on the matter.

Registrar Corp is an FDA consulting firm that helps drug companies understand and comply with FDA regulations.  We will continue to update the industry as FDA’s decision regarding its enforcement policies for homeopathic drugs unfolds.  For questions about homeopathic drugs or other current FDA regulations for drug companies, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day through Live Help.





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