“Risk-Based” Enforcement Approach to Homeopathic Products Will Be Taken By Federal Regulators

FDA will only step in with enforcement when homeopathic products constitute a potential health threat, according to new guidance issued this week

The U.S. Food and Drug Administration (FDA) issued final guidance this week which indicates the agency intends to take a “risk-based” approach to enforcing regulations regarding homeopathic drug products sold to Americans.

The updated position was published in the Federal Register (PDF) on December 6, after a draft guidance was issued in October 2019. The agency also withdrew a Compliance Policy Guide, which limited the FDA’s enforcement on homeopathic products.

The guidance focuses on prioritizing categories of homeopathic products that are considered higher risk for some consumers. These are products that may pose side effects for those with weakened immune systems, infants and children, the elderly, and pregnant women.

The guidance also focuses on ophthalmic and injectable products. The routes of administration for injectable drug products bypass some of the body’s natural defenses and can pose a greater risk in some cases.

Homeopathic Drug Risks

Homeopathy is an alternative medicine practice developed in the late 1700s. It is based on the principle that a substance which causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses.

Drug products sold as homeopathic remedies are made from a wide range of substances, including ingredients derived from plants, healthy and diseased animals, human sources, minerals, and chemicals. Some are known to be safe, but others have been found to be poisonous or toxic, depending on the dose or quantity.

The products are often marketed as natural alternatives to prescription and non-prescription drugs, which are widely available in the U.S., but require an FDA approval process to confirm they are safe and effective.

In recent years, the FDA has issued warnings to about serious risks identified with certain homeopathic products. The warnings highlighted products containing toxic substances, such as belladonna, and products made under poor manufacturing standards, which led to contamination and recalls.

Currently, there are no FDA-approved products labeled as homeopathic. The agency said it cannot ensure the safety of homeopathic products, as they do not meet the FDA’s standards for effectiveness and quality.

The FDA anticipates many homeopathic products will fall outside the categories of regulation for drug products intended to be under this enforcement but highlights efforts to enforce regulation and safety on these products.