FDA Regulations Too Lax on Enforcing ‘Misleading’ Growth Enhancement Claims for Antibiotics


Novartis, the mega drug manufacturer, has been accused of using its promotional materials for an antibiotic livestock feed additive to promote animal growth enhancement rather than for its intended use of treating dysentery, pneumonia and enteric disease in pigs, despite FDA regulations.

Now, the advocacy group Keep Antibiotics Working is urging the FDA to do something about it.

The group first alerted the FDA about the misleading language last May. “FDA told the coalition via email that they had discussed the issue with Novartis, but the agency would not reveal any details about the substance of their conversation,” explains Food Safety News.

Last June, KAW noticed that the company had “modified the drug’s marketing page for the better, but the coalition didn’t think the changes were adequate,” Food Safety News explained. “They met with FDA in July to explain their overall concerns and to ask the agency to clarify that this type of advertising would not be tolerated.”

Then, last month, Novartis’ marketing claims returned to previous language, like “grow-finish performance.”

The drug in question includes Denagard (tiamulin hydrogen fumarate), combined with chlortetracycline (CTC), and was “never approved for growth promotion”, Food Safety News explains, “but is included in the list of products affected by FDA Guidance #213.” The group’s concern is over the fact that since Novartis is able to get away with the claims now, new FDA regulations and guidance rules won’t prevent the company from continuing to promote growth enhancement from its additives.

KAW says that Novartis’ promotional materials are “misleading because they claim that the product can be used for more than what’s on the approved label, they fail to reveal important facts about Denagard plus chlortetracycline, they make claims that are not supported by substantial evidence, and they leave out important risk information,” reports Food Safety News.

“The misleading statements on the Novartis website are no less misleading than the statements in promotional materials that FDA has routinely challenged, yet we still have not seen any evidence that FDA has asked Novartis to remove the misleading information from its marketing materials,” Steven Roach, director of the food safety program at the Food Animal Concerns Trust, a KAW member organization, wrote in a letter to the FDA.

Guidance #213 is considered weak by a number of health advocacy organizations, and KAW specifically is concerned that the FDA has lost its ability to “enforce even a minimal standard.” Roach said that public trust wanes “when we have the regulatory agency and the industry come together with a plan that seems to be more designed to modify perception of how antibiotics are used on farms instead of actually trying to reduce overuse.”

Find Jill on Twitter @jillettinger

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