Homeopathy Industry Threatened by New FDA Guidance
By Marina DeWit, Region 9 Advocate
According to the National Institute of Health, more than 6 million people in the United States use homeopathy to treat specific health conditions, and over 200 million people use homeopathy on regular basis worldwide. Homeopathy is a form of medicine based on the idea that the body can heal itself. It uses small amounts of natural substances, such as plants and minerals, to stimulate the healing process. More than 8,000 homeopathic remedies are available over the counter and most users self-prescribe products for common issues, such as cold symptoms or mild pain.
Business owner Anna Vakil first became interested in homeopathic medicine when searching for ways to help keep her children and family healthy. After a bad experience with traditional medicine, she was motivated to take courses on homeopathy and become a certified homeopathic practitioner in Yuma, Arizona. Vakil helps clients with a broad range of health issues by providing consultation and recommendation of homeopathic medicine. Even though most low potency drugs are easily available to consumers, Vakil can “prescribe” items that come directly from homeopathic labs in the region. While her seven-year-old practice is doing well and growing, the future of her business is threatened by new Food and Drug Administration (FDA) guidance declaring homeopathic medicines to be “new drugs.”
In October 2019, the FDA withdrew the previous rules regarding homeopathic medicine and published “Revised Homeopathic Draft Guidance.” According to the FDA, the increase of homeopathic product availability coincided with an increase of reports of toxicity and adverse reactions. Some specific medicines are mentioned by the FDA as the result of a concern for safety. The new guidance will reclassify all homeopathic drugs as unapproved “new drugs,” thus making them subject to withdrawal from the marketplace.
The homeopathy community is deeply concerned with the FDA’s approach. The $1.2 billion industry is driven by small businesses and creates jobs for manufacturers, pharmacists, practitioners, and educators. Homeopathic practices like Vakil’s will be threatened and could be shut down completely. These include homeopathic medicine laboratories and manufacturers, health food stores and vitamin shops, education programs, and other industries associated with homeopathy. Ordering homeopathic medicine from abroad will not be possible as the shipments of banned remedies will be stopped at the border.
The FDA will allow for homeopathic remedies to be reinstated by submitting a new drug application (NDA). However, homeopathic remedies cannot be patented because they are made from common substances and, since approving each new drug is very costly, companies would not financially benefit from going through the process. Also, NDAs are designed for pharmaceuticals that are tested on a large mass of people with the same condition. Homeopathic medicine is tailored to an individual based on his or her physical, mental, and social condition, making it more complicated for a substance to be ruled as safe and effective by the FDA.
Vakil and her colleagues agree that the regulation on labeling needs to be addressed to prevent non-homeopathic products from being advertised as homeopathic. Also, they agree that remedies that have already been proven dangerous by FDA should be removed from the marketplace as soon as possible.
The Americans for Homeopathy Choice along with other organizations and small businesses are trying to persuade FDA to revise the draft guidance. You can read the draft guidance and submit a comment if this will impact your business. Comment deadline: Mar. 23, 2020.
Marina DeWit serves as the Region 9 Advocate for the SBA Office of Advocacy, representing small businesses in Arizona, California, Nevada, Hawaii, and the Pacific Islands of Guam, American Samoa, Commonwealth of the Northern Mariana Islands, and Trust Territories. DeWit works with small business owners, state and local governments, and small business associations to bring the voice of Region 9 to Washington DC. She can be reached at Marina.DeWit@sba.gov.