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What is the FDA?

The FDA, or Food and Drug Administration, is the U.S. government agency responsible for protecting the health of the public by assuring the safety, efficacy and security of human and veterinary drugs as well as biological products, medical devices, food and more.

As part of this effort, the organization works to speed up the innovations that make medicines and foods more effective, safer and more affordable.

The agency also works to help the public get accurate, science-based information on these medicines and food so that people can make wise decisions about their health.

Homeopathic Medicines and the FDA

The FDA regulates the manufacturing, labeling, marketing and sales of homeopathic medicines. Homeopathic medicines have been regulated as drugs by the FDA since the federal Food, Drug, and Cosmetic Act was passed in 1938.1 Being regulated as drugs instead of as food or dietary supplements is an important distinction—more on that shortly.

So what does the FDA require for a medicine homeopathic to go to market?

To be accepted as a homeopathic medicine by the FDA, the product must contain ingredients that are identified in the Homeopathic Pharmacopoeia of the United States (HPUS) or that are accepted as homeopathic under the principles of homeopathy.

To be included in the HPUS, which has been in continuous publication since 1897, a homeopathic drug must be determined safe and effective, must be prepared according to the specifications set forth in the HPUS, and the drug’s benefits must be established in one of the following ways: through clinical verification; published documentation that the substance was in use prior to 1962; through two adequately controlled double-blind clinical studies; or though data gathered from clinical experience that encompasses the symptom picture before and after treatment.

Look for the HPUS Acronym

All of Boiron’s homeopathic medicines are manufactured according to the highest standards, complying with specifications of HPUS as well as drug Good Manufacturing Practices, which require that manufacturers take proactive steps to ensure that their products are safe, pure and effective.

Drug Labeling

As we said earlier, the FDA regulates homeopathic medicines as drugs, as opposed to food or dietary supplements. This type of regulation ensures that homeopathic medicines adhere to drug labeling specifications.

Like packaging for over-the-counter drugs, the packaging for homeopathic medicines must include the:

  • specific diseases, ailments or symptoms for which the product is to be used,
  • concentration of the active substance or substances contained in the product,
  • recommended dosage,
  • directions for use, and
  • warnings

The FDA oversight of homeopathic medicine means clear specifications on product packaging, making choices easier for consumers and guidance easier for retailers.

Add to that an adherence to the highest standards, and you’ve got a line of top-quality medicines at Boiron.

1. Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry (revised draft). U.S. Food and Drug Administration. October 2019. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-products-labeled-homeopathic-guidance-fda-staff-and-industry.