Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed” document presents to the supplements trade.
One of the most vocal critics of the NDI draft guidance, California-based Jarrow has repeatedly called on the FDA to ditch the controversial draft guidance, which it argues is “already being used as a hammer to blunt the industry”.
It has also called for Congressional hearings on the controversial document, which it describes as a “blatant attempt to regulate and indeed legislate via a guidance document”.
‘We urge you to convene hearings or an inquiry’
In a 15-page letter to Boehner dated May 21, Scott Polisky and Dr Susan Brienza - regulatory attorneys for Jarrow - wrote: “We urge you to convene hearings or an inquiry into the FDA’s handling of dietary supplements.
“In particular, the FDA should be required to withdraw the current guidance and produce a new draft guidance for comment that is truly consistent with and harmonious with the purpose and intent of Congress in DSHEA [1994 Dietary Supplement Health and Education Act].”
Polisky, who met Boehner in May, claims that both the Speaker and his legislative aide for health policy have "expressed a serious interest in further considering and exploring supplements industry concerns about FDA over-regulation".
Meanwhile, Polisky says Jarrow is still waiting for a meaningful response from the FDA to most of the key questions outlined in a Freedom of Information Act (FOIA) request it submitted last September about the NDI draft guidance.
Jarrow specifically asked the FDA to explain the scientific basis for its proposed policy on chemical alteration and synthetic botanicals and to give a detailed explanation of its thinking about probiotics within the context of NDIs.
It has also asked the FDA to provide hard data about its safety concerns about dietary supplements and precisely how these might be remedied by the NDI guidance, said Polisky.
"After FDA avoided answering close to 70% of the 128 FOIA requests... Jarrow filed an appeal on February 21, with a May 19 follow-up letter, objecting to the refusal of FDA or the FOIA Office to meaningfully respond. In a May 24 reply, the FOIA Office stated that it is continuing to process your appeal' but has produced no further information to date."
Stellar safety record
Brienza added: "All consumers seem to hear about in relation to dietary supplements at the moment are concerns about spiking with steroids or other drugs. But we need to remind people that the dietary supplement industry has a stellar safety record.
"To put this in perspective, thousands of deaths a year are caused by food poisoning and prescription drugs. The dietary supplements industry has an exemplary safety record vis-a-vis other FDA-regulated products."