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Rules over animal dietary supplements 'in disarray'

September 16, 2008

A report on animal dietary supplements to the United States Food and Drug Administration says rules surrounding their use are in "disarray".

The report stresses that clear and precise regulations need to be established so "only safe animal dietary supplements are allowed on the market".

The report also raised several concerns over the safety of specific supplements and the approaches taken to determine their safeness.

The National Research Council report, requested by the Center for Veterinary Medicine of the US Food and Drug Administration, assesses whether the addition of three dietary supplements - lutein, evening primrose oil, and garlic - to the diets of horses, dogs, or cats may cause significant adverse health effects.

The committee that wrote the report concluded that because of inadequate data, it could not clearly define a safe upper limit for the three supplements, but it could cite historical safe intakes and estimate presumed safe intakes based on available research findings.

Describing current regulations covering animal dietary supplements as in "disarray", the report stressed that clear and precise regulations were needed to ensure the safety of animal dietary supplements on the market.

An improved adverse-event reporting system for animal dietary supplements would help, the report said. It said existing systems have various deficiencies, including limited public access, passive rather than active solicitation of adverse events, and unclear discrimination of minor versus serious adverse events.

Additionally, the "generally recognized as safe" designation used for both human and animal ingredients is helpful in determining safe intake levels, but safety in humans does not guarantee safety in animals, the committee noted.

For example, excess garlic intake can cause hemolytic anemia in horses, dogs, and cats, but this adverse effect has not been reported in humans.

The passage of the Dietary Supplement Health and Education Act (DSHEA) in the United States in 1994 amended the way in which dietary supplements for humans are regulated, but the Food and Drug Administration concluded the law should not apply for animals.

As such, animal dietary supplements are typically regulated as "food" without the special consideration afforded to supplements marketed for humans.

The Association of American Feed Control Officials also sanctions the ingredients used in animal feeds, which states typical use guidelines, but it does not dictate minimum or maximum amounts of nutrients allowed in a product.

The daily presumed safe intakes (PSI) and historical safe intakes (HSI), given in milligrams per kilogram of body weight (mg/kg BW), determined by the committee for the three dietary supplements are:

The study was sponsored by the US Food and Drug Administration. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter.

The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering.



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