Food and Drug Administration | Horse Racing Free Tips

Edited Press Release

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 (HISA)'s 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 Apr. 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 mscollay@hiwu.org.

The post HIWU Issues Statement On Dietary Supplements appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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An employee of Florida veterinarian Seth Fishman last week permitted Federal Bureau of Investigation (FBI) agents to search her workplace, and the inside tip has allegedly yielded evidence that Fishman is still selling purportedly performance-enhancing drugs (PEDs) while awaiting an expected January start to his trail in the international racehorse doping conspiracy case.

“Remarkably, despite having been arrested in October 2019 and indicted in 2020 in connection with his sale of misbranded and adulterated drugs designed to be 'untestable' by various antidoping authorities, Fishman apparently persists in touting the efficacy of his drugs in evading antidoping testing regimes, labeling his new batches of HP Bleeder so as to indicate to his clientele that they contain no known 'testable' ingredients,'” stated a Dec. 6 court filing by the prosecution that asked a judge to consider revoking the bail terms of Fishman's pretrial release.

Fishman is charged with two felony counts related to drug alteration, misbranding, and conspiring to defraud the government. His case is being heard in United States District Court (Southern District of New York).

According to the filing, in the course of proffering an unnamed potential trial witness who has been a “long-time employee of Fishman's illegal drug distribution business” (variously operating under the names Equestology, Camelology, Equi-Tech and other monikers), the government was informed on Nov. 9 by “Employee-1” that Fishman's business “continued to operate in a purportedly limited” capacity.

“More specifically, Employee-1 informed the Government, in substance and in part, that Fishman's business was creating 'energy drinks' for foreign distribution and that Employee-1 remained tasked, by Fishman, with continuing to create a 'bleeder' paste (itself a drug containing active pharmaceutical ingredients), which Employee-1 also described as being for foreign distribution,” the filing stated.

“As charged in the Indictment, Fishman's drug operation is not registered or licensed with the Food and Drug Administration (FDA) to create, manufacture, and distribute drugs, including the 'bleeder' paste reportedly in continued production,” the filing stated.

After initially providing this information, Employee-1 and her attorney consented for FBI agents to accompany her to where she works for Fishman on Dec. 3.

“At that time, the FBI agents (accompanied throughout by Employee-1) discovered that Fishman is continuing to produce and distribute not only the paste identified by Employee-1 and the purported 'energy drinks,' but additional injectable, misbranded and adulterated PEDs, including the injectable drugs 'HP Bleeder' and 'PSDS: Pain Shot DS.'

“Labeling on certain of the vials discovered during this consent search reflect that Fishman continues to create and distribute these drugs today, including 'date of manufacture' markings reflecting activity even into 2021,” the filing stated.

The filing stated that “shipping material for 'E.G.H.' appears to be recently created packaging for equine growth hormone, a substance that, like HP Bleeder and various pain shots, were also sold by Fishman during and as part of the charged conspiracies.”

In asking the judge to consider revoking Fishman's bail, the filing stated that, “In addition to constituting evidence of the charged offenses and reflecting continued violation of federal law, the recent search reflects Fishman's failure to comply with the most basic term of his pretrial release, namely that he not 'violate federal, state, or local law while on release.'

“The drugs found in Fishman's offices continue to be manufactured through the same unregistered, unlicensed business that forms the basis of the charged offense, and include the drug 'HP Bleeder' previously obtained from multiple searches of premises controlled by Jorge Navarro, Lisa Giannelli, Christopher Oakes, as well as [other defendants],” the filing stated.

“As such, there is ample basis for a finding of probable cause that Fishman has flagrantly violated the terms of his pretrial release by committing an ongoing federal crime,” the filing stated.

The judge in the case immediately ordered a Dec. 20 hearing on the bail revocation request.

Fishman's attorney, Maurice Sercarz, told TDN in an email that “We will vigorously oppose any effort by the Government to modify Dr. Fishman's bail on the theory that he has engaged in continuing criminal conduct.”

The post Feds: Fishman Still Selling PEDs Even as Trial Date Looms appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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