HIWU Notice on Dietary Supplements and Institution of 30-Day Grace Period

The Horseracing Integrity & Welfare Unit (HIWU) calls the Thoroughbred industry’s attention to regulations regarding the possession and use of dietary supplements under the Horseracing Integrity and Safety Authority’s (HISA) Anti-Doping and Medication Control (ADMC) Program.

The ADMC Program permits the possession and use of dietary supplements such as vitamins, minerals, herbs, and homeopathic products. Under the Federal Food, Drug, and Cosmetic Act, such products are not considered drugs, and therefore do not require approval from the Food and Drug Administration (FDA). However, Covered Persons should be aware that dietary supplements are not regulated, and that positive test results stemming from the presence of a Prohibited Substance in a supplement, whether or not it was properly labeled, will be prosecuted by HIWU as ADMC Program violations.

The FDA defines a drug, in part, as a substance that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Consequently, supplements with “drug claims” on the label, e.g., “treats ulcers,” “mitigates bleeding,” or “prevents tying up,” are considered unapproved animal drugs that lack FDA approval. All drugs that are not approved by the FDA are categorized as Banned Substances (S0) under the ADMC Program.

However, HIWU is instituting a 30-day grace period for the possession of supplements with labels that make such prohibited drug claims.

Through April 30, 2023, HIWU will not prosecute Covered Persons for the possession of supplements with labels that include drug claims. However, if a Covered Horse receives a positive test result for a Prohibited Substance as a result of the use or administration of one of these products, HIWU will prosecute the positive test result as an ADMC Program violation.

HIWU recommends that supplement manufacturers ensure that product labeling and website information are in compliance with FDA requirements for dietary supplements. They should also contact any vendors, distributors, or other clients to replace or relabel inventory as needed.

Questions about dietary supplements should be directed to Dr. Mary Scollay, HIWU’s chief of science, at [email protected].