Re: FDA's "New Dietary Ingredient Guidance" DECIMATES New Dietary Ingredients–and most products on your shelf

Dear Retailer,

    On July 1st, the FDA issued Draft Guidance for New Dietary Ingredients (NDIs). The FDA's new policy must be commented on by December 2, 2011; and we at Jarrow Formulas urge you to submit your comments. Here's why: should this NDI policy become the Final Guidance, the entire natural products industry is facing a scenario, in which:

  1. Companies would have a difficult time even showing that a dietary ingredient was a pre-DSHEA ingredient, grandfathered in, and thus not needing an NDI Notification at all.
  2. Every new (post-DSHEA) ingredient and formula would require an NDIN (New Dietary Ingredient Notification), creating longer lead times for product release.
  3. For every new ingredient or new formula, a company would need to file a successful NDI Notification prior to marketing the product. Yet so far, the FDA has rejected 75 – 83% of all NDI Notifications—and the future safety testing requirements would be even tougher.
  4. Every NDI Notification would require a significant amount of research—including toxicology studies for perfectly safe ingredients—that could cost millions of dollars and potentially limiting the product from ever being sold. Tests would also have to be performed on formulas that contain ingredients that have been in use for 50 years, potentially robbing consumers of the supplements they rely upon.
  5. Each company would have to file its own NDI Notification for the same new ingredient that some other company tested as safe, and already got FDA clearance for, with a successful NDI Notification.
  6. Contrary to Section 8 of DSHEA, each "new" formulation using old, pre-DSHEA ingredients, but perhaps formulated in a different way, will require an NDI Notification.
  7. The FDA's decision on an NDI Notification takes at least 75 days, but a much longer time is needed for all the additional lab tests and safety studies now required for the Notification.
  8. The Draft Guidance questions whether Probiotics are even dietary ingredients—that is, whether they can be sold as supplements at all.
  9. New dietary ingredients that do manage to jump through several new hoops, and get FDA- "acknowledged" to go on the market, may take years as well as lots of money—thus putting a damper on innovative, beneficial products for the American consumer.
  10. The FDA's over-reaching scheme will drive most products off the shelf and most companies out of business.

    The FDA, which was never in favor of DSHEA, finally hopes it will get its way and destroy the supplement industry.

    The current NDI Draft Guidance is such a regulatory nightmare that if it had been in place 30 or 50 years ago, there would not even be vitamin B complex, or vitamins C, D, or A unless the FDA wrote an "exception." And Co-Q10 would never have been allowed.

    It gets worse. Did you know that Daniel Fabricant, Ph.D., the former #2 and #1 executive at the Natural Products Association (NPA, formerly NNFA) was hired by the FDA and is now their Director of Supplement Programs. This once industry advocate is now working for the FDA, to regulate dietary supplements out of existence. Does that sound ethical to you? Please read the attached letter written by Jarrow L. Rogovin, Founder and President of Jarrow Formulas to the Commissioner of the FDA, Dr. Margaret Hamburg. Jarrow does not think it is at all ethical, and he is letting the FDA and your elected officials know.

    Don't let the FDA take away your access to dietary supplements! Here is what you can do:

  1. Read Jarrow's letter ( http://www.jarrow.com/eMarketing/Hamburg-Fabricant-Jarrow-Letter-8-2011.pdf) and then send your support of Jarrow's letter to Dr. Hamburg: Margaret.hamburg@fda.hhs.gov.
  2. Write your elected officials and let them know you are opposed to the new NDI Draft Guidance:
    1. Write your Congressperson:
      ( https://writerep.house.gov/writerep/welcome.shtml)
    2. Write your Senator:
      ( http://www.senate.gov/general/contact_information/senators_cfm.cfm)
  3. Let FDA know you completely oppose the NDI Draft Guidance by submitting your comments to the docket with this model comment letter.
    ( http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0376-0002)
  4. Get your friends and customers mobilized to fight to keep access to the dietary supplements they depend on for their health and well-being. (Bag-stuff this information, e-mail it, post it on facebook and twitter!)

Don't let the FDA take away your access to supplements. Let your voice be heard today!