Bottles of homeopathic globules and healing herbs and flowers. Homeopathy medicine.

FDA Aims to Crack Down on Homeopathic Drugs


The Food and Drug Administration (FDA) proposed on Monday to implement stricter policy enforcement against homeopathic drugs. The agency says it would target products with the greatest safety risks, including those with harmful ingredients and products being marketed for cancer, addiction and heart disease.

Homeopathy is based on the notion that substances causing diseases can cure them if taken in very small doses. Research and studies have shown that homeopathy products are ineffective at best and dangerous at worst.

U.S. laws require homeopathic drugs to meet the same approvals as regular drugs. However, a 1988 policy allows for “enforcement discretion” In other words, the items can be manufactured and sold without the FDA’s approval.

The FDA acknowledges that it would be impractical to require homeopathic drugs to be approved, but the agency aims to increase its scrutiny for items that may be a health threat. High-risk products can include those administered by injection, those marketed for serious diseases and those intended for the elderly or children.

The FDA’s move comes after teething tablets and gels containing belladonna contributed to 10 deaths and 400 injuries in children.

The agency has released draft guidance, which will be open to the public for the next 90 days.

Homeopathy has grown to become a $3 billion industry with products that claim to treat just about every ailment, including cancer.

The FDA does note that they will not target products that aren’t considered high risk. These products will still be available to consumers. The FDA would only target products that are – or might – cause harm.

The FDA held public hearings in April 2015 regarding homeopathic products. After hearing 9,000 comments, the agency has decided to propose a new enforcement approach to drugs being “labeled as homeopathic and marketed without FDA approval.”

The U.S. isn’t the only country cracking down on homeopathic medications. Britain’s National Health System announced in July that doctors would no longer be able to prescribe homeopathic medications.