Keep Antibiotics Working (KAW) is on the Food and Drug Administration’s (FDA) case again about the growth promotion marketing loophole for antibiotics. Last May, KAW alerted FDA to their concerns that drug manufacturer Novartis was using promotional materials for a feed additive used to treat dysentery and pneumonia and enteric disease in pigs that spoke more to production issues than animal health. 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. In 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. 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. The group viewed FDA’s response as non-committal and was frustrated to see that the company had reverted back to some of its original marketing language in October, once again emphasizing the improvements of “grow-finish performance.” Either FDA hasn’t told Novartis to stop or the company is ignoring the agency, said Steven Roach, director of the food safety program at the Food Animal Concerns Trust, a KAW member organization. “In either case, it’s a problem,” he said. The feed additive containing Denagard (tiamulin hydrogen fumarate), in combination with chlortetracycline (CTC), was never approved for growth promotion, but is included in the list of products affected by FDA Guidance #213. KAW is concerned that if the company can get away with extra label marketing for growth promotion now, then the full implementation of the guidance won’t change anything. Roach wrote to Michael Taylor, FDA’s deputy commissioner for food and veterinary medicine, again this week on behalf of KAW, reiterating that, in the group’s view, Novartis’ promotion 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. “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,” Roach wrote. The letter also identifies advertisements by Elanco that similarly make the claim that growth benefits result from preventing disease. Roach told Food Safety News that FDA might be waiting until Guidance #213 drugs are brought under veterinary control, but that it’s hard to say what FDA might do about publicity when they haven’t been clear about how they will enforce label requirements. “If it’s OK for them to do this now, it’s going to be OK for them to do this in three years,” Roach said. Because the promotion is suggesting the drug be used for something it’s not approved for, “There’s no reason for them to wait to crack down,” he added. “As part of the GFI #213 implementation process, we intend to look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials,” an FDA spokesperson said. “We are in the early stages of implementing this strategy. Important issues will arise along the way, and we are committed to addressing them.” Many public health advocates consider Guidance #213 too weak to decrease antimicrobial use on farms, but Roach fears that the extra-label promotion indicates FDA’s inability to enforce even a minimal standard. It erodes the trust of the public “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,” he said.