At last check, the supplement industry was waiting with bated breath for the FDA’s response to the new product. Now, some lawmakers in Washington are turning to Bayer for answers.
Democratic Representatives John Dingell and Bart Stupak of Michigan, along with HealthCare President Gary Balkema, have sent a letter to Bayer asking for clarification on why the company chose to proceed with the production of its crossover product despite a previous FDA recommendation that seems to caution against it, “The FDA strongly recommends that firms refrain from marketing products that combine or co-package drug and dietary supplement ingredients,” said then-Associate Commissioner for Policy Margaret Dotzel in May 2000.
The legislators have called for Bayer to respond within two weeks, “The [Oversight and Investigations Subcommittee] is concerned that your company engaged in DTC (direct-to-consumer) advertising of this product, particularly in light of FDA's recommendation to refrain from marketing combination products.”
Many in the supplement industry hope that Bayer will be able to satisfy the committee’s requirements so that the door will be open to future crossover supplement products. In a recent interview with NBJ, the Council for Responsible Nutrition (CRN) President and CEO Steve Mister commented on the potential FDA ruling, “We [the dietary supplement industry] ought to be helping the FDA to say, ‘yes,’ rather than daring them to say, ‘no.’”