In a letter to FDA commissioner Dr Margaret Hamburg dated July 9, 2013, 27 key members of Congress “encourage the agency to continue its efforts to bring clarity to this area of regulation, as it is critical to ensure consumers have access to safe and affordable dietary supplement products.
“We hope that you will work toward completion in a timely manner.”
The bipartisan letter, led by Congressmen Pallone (D, NJ) and Guthrie (R, KY), is signed by key members of the Energy and Commerce Committee, the Dietary Supplement Caucus, and other legislators.
The NDI guidance has had a convoluted history since it was first introduced in draft form in July 2011. Industry groups raised concerns that the guidance went beyond the language of the Dietary Supplement Health and Education Act language it was meant to interpret and constituted ‘law making by guidance.’
After a series of high level meetings that included Sens. Orrin Hatch and Tom Harkin, FDA agreed to sit down with industry stakeholders to work on possible revisions. Several meetings between FDA and industry trade organizations have taken place over the past year, with neither side willing to discuss the particulars of those meetings publicly.
“Concerned about the speed of progress”
“Congress, FDA and the dietary supplement industry all agree that guidance for industry on the New Dietary Ingredient (NDI) notification process is needed,” states the letter.
“We appreciate the agency's willingness to engage with industry on this important issue and work toward a revised guidance that reflects a fair and workable NDI notification system, based on the principles outlined in the Dietary Supplement Health and Education Act (DSHEA). We are also pleased that you are dedicating staff time to work cooperatively with industry.
“However, we remain concerned about the speed of progress on these discussions and when we can expect the agency to release a revised guidance.”
House of Representatives
The letter follows a similar message from the US House of Representatives Appropriations Committee. A report from the committee that would, once its finalized, accompany the Fiscal Year 2014 Agriculture/FDA Appropriations bill, includes a list of actions of actions the committee wants FDA to take and deadlines for reporting on its progress.
Speaking with NutraIngredients-USA, Mike Greene, VP of government relations for the Council for Responsible Nutrition (CRN) said: “We haven’t seen a reaction from FDA yet, but I suspect we’ll see that next week [when the industry trade associations have their fourth meeting with FDA to discuss the draft guidance].
“If we look at the tone and tenor of the letter, it looks like Congressmen Pallone and Guthrie are asking for a progress report from FDA, and they want to see things moving a little more quickly,” he said.
Resolving the outstanding areas of disagreement by the end of this year would be “ambitious”, said Greene, “but, truthfully, nothing is ever quick. Also, we need to take time to make sure that the result is in-line with DSHEA and something that both industry and FDA are happy with.”
Among the concerns of industry that still need to be addressed are these:
- Synthetic botanicals. FDA specifically excluded these from the sphere of lawful dietary ingredients in the draft guidance. Strong objections to this were raised, including the observation that synthetic versions of vitamins have been on the market for decades without objections from FDA and without safety concerns.
- Chemical alteration. In the draft guidance, FDA took a very restricted view of what chemical processes can be used to extract an ingredient without changing its chemistry to the point where the ingredient is no longer what it once was and new safety data would need to submitted. Industry responded that the manufacturing advances of the past 20 years do not pose safety concerns and taking FDA’s restricted view, many ingredients on the market would be classified as NDIs.
- Lists of Old Dietary Ingredients. DSHEA included a grandfather date of Oct. 15, 1994. Anything on the market as of that date was designated as an ODI and was exempted from filing a NDI notification. In the draft guidance, FDA rejected the idea of using any of the several industry lists of what was being sold at that date to establish the NDI/ODI status of ingredients. The agency has since shown more flexibility on this matter.
- Finished products vs. ingredients. In its present form, the draft guidance appears to call for a NDI notification on new finished products that contain NDIs. Industry stakeholders believe that NDI notifications should be required for ingredients only, with that safety information applying to the finished products containing that ingredient.