Jarrow calls for Congressional hearings to address NDI guidance woes

By Elaine Watson

- Last updated on GMT

Related tags: Ndi draft guidance, Dietary supplement, Fda

Speaker Boehner was receptive to Jarrow Formula's concerns about the FDA's NDI draft guidance during a meeting in LA last month, claim its regulatory attorneys
Speaker Boehner was receptive to Jarrow Formula's concerns about the FDA's NDI draft guidance during a meeting in LA last month, claim its regulatory attorneys
Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed”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One of the most vocal critics of the NDI draft guidance, California-based Jarrow has repeatedly called on the FDA to ditch the controversial draft guidance, which it argues is “already being used as a hammer to blunt the industry”.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“In particular, the FDA should be required to withdraw the current guidance and produce a new draft guidance for comment that is truly consistent with and harmonious with the purpose and intent of Congress in DSHEA ​[1994 Dietary Supplement Health and Education Act].”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".

FOIA request

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of the key questions outlined in a Freedom of Information Act (FOIA) request it submitted last September about the NDI draft guidance.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."

Related news

Show more

Related products

show more

It’s time for HRB – A lifelong health partner

It’s time for HRB – A lifelong health partner

Morinaga Milk Industry Co., Ltd. | 19-Nov-2020 | Technical / White Paper

Consumer awareness of the importance of choosing the right probiotics that possess extensive clinical efficacy to address fundamental health problems (e.g.,...

Next-wave sports nutrition innovation today

Next-wave sports nutrition innovation today

ADM | 28-Oct-2020 | Technical / White Paper

Today’s consumers are passionate about embracing health in many aspects of their lives, starting with customizing their nutrition. Rooted in proprietary...

Biotis™ - Solutions for a good gut feeling

Biotis™ - Solutions for a good gut feeling

FrieslandCampina Ingredients | 07-Oct-2020 | Product Brochure

Discover our range of GOS (galacto-oligosaccharides) with scientifically proven effects to significantly increase levels of ‘friendly bacteria’ in the...

Related suppliers

Follow us

Products

View more

Webinars