FDA Warns Ulcer OTC Marketers

Online marketing of several over-the-counter drugs for horses has come under increased federal scrutiny according to warning letters dispatched by the Food and Drug Administration (FDA) on Oct. 29, 2014. The letters, which originated in the Florida District of the FDA’s Pubic Health Service, were directed to Simon Jones (owner of the Internet site www.horseprerace.com), Dr. Scott Mangini (owner of Horse Gold, Inc.), and Jerry and Harry Glantz (owners of Tri-Star Equine Marketing, Inc.). All three letters made similar claims, that the recipients were marketing animal health products as “drugs” without approval from the FDA.

The Jones letter (http://fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421133.htm) claimed that a number of products being sold through the horseprerace.com website,including Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, Gastromax3, Flunixin, Synedem, Toltrazuril Paste, and Super Tie Up, were drugs that had not been submitted to the FDA for approval. The Mangini (http://fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421146.htm) and Glantz (http://fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421167.htm) letters made the same assertions regarding marketing of the products GastroMax3 and Gastrotec, respectively.

The warning letters would have effect only if the products are, in fact, drugs. The word “drug” has a specific meaning for FDA purposes. The statutory definition is found at 21 U.S.C. § 321(g)(1): “articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” This definition does not include dietary supplements, so long as the supplements are not marketed as drugs, satisfy various statutory requirements, and are marketed with a “truthful and not misleading statement.”

Based on the language used in ads for the products in question, the FDA inferred that they were intended for “use in diagnosis, cure, mitigation, treatment, or prevention of disease” and therefore satisfied the statutory definition of a “drug” requiring government approval. With one exception, the complaints from the FDA address only marketing, and not the safety or effectiveness of the implicated products. Examples of the problematic marketing language cited by the FDA include:

  • Gastrotec—“For the care of gastric and colonic ulcers in horses,” “Gastrotec is the first product to conquer gastric ulcers in horses while also reaching the hind gut and treating the ‘colonic’ ulcers,” and “The newest innovation in the battle against equine ulcers.”
  • Gastromax3—“The ultimate in equine ulcer care,” “Gastromax3 is a special combination of three ingredients that work together and can give your equine the protection it needs against gastric ulcers,” and “formulated for one of the most prevalent problems in the equine industry.”
  • Omeprazole Oral Paste—“INDICATIONS-Ulcers, poor condition, dull coat, loss of appetite.” “CATEGORY-Stomach care, equine ulcers, EGS.”
  • Flunixin—“recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse, dogs and camels.”
  • Toltrazuril Paste—“represents a new standard in coccidiosis control in Race Horses, Camels, Pigeons, Greyhounds & Alpacas.”

The FDA also tested samples of one of the named drugs, Omeprazole Oral Paste, and found that the concentration of the active ingredient—omeprazole—did not correspond to the concentration listed on the label. This discrepancy allowed the FDA to classify Omeprazole Oral Paste as “adulterated” under the statutory definition of a drug whose “strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.”

FDA approval of a new drug requires extensive testing by the manufacturer to demonstrate that the drug is: 1) “safe and effective for a specific use in a specific animal species,” 2) that the “manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity,” and 3) that the labeling is “truthful and complete.” Gaining FDA approval for a new drug clearly is a difficult road.

A review of the FDA’s Approved Animal Drug Products publication (the so-called “Green Book”) identifies only two drugs with omeprazole as the active ingredient that have won FDA approval—Merial’s Ulcergard and GastroGard. The FDA’s Freedom of Information Summaries for those two drugs include reports of both pharmacological studies and clinical trials establishing to the FDA’s satisfaction that the drugs are safe and that they do what there are supposed to do.

Development of a new drug is time consuming and expensive, and one way for a manufacturer to cut costs is to bypass the approval stage and offer the drug for sale without legal marketing status. The FDA’s position on unapproved animal drugs is one of “serious concerns” and a warning letter generally is the first step in enforcing compliance with statutory requirements.

“With no FDA review of an animal drug, there is no way for veterinarians, pet owners, and animal producers to know if a drug is safe and effective or if its manufacturing process is adequate to maintain the drug’s quality and consistency from batch to batch,” according to a statement at www.fda.gov. “By bypassing the FDA’s drug approval process, drug companies that make and sell unapproved drugs potentially put the health of animals and people at risk.”

Recipients of the Oct. 29 warning letters have 15 working days after receipt to notify the issuing FDA office of steps taken to “bring their firm into compliance with the law” or to state the reasons for any delay along with the date of expected compliance.

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