Update of FDA proposed NDI regulations

    During the last couple of months, I have posted two articles on this blog concerning the US FDA's guidelines for NDI's (New Dietary Ingredients).  As these guidelines stand they will force the majority of supplement manufacturers out of business and severely curtail the availability of supplements in the US.

    The link for my first post "Is this the beginning of the end for Supplements" can be accessed by clicking here.

    The second post "An Update on the FDA's attack on Dietary Supplements" was is here. 

    OK…the update.

    The week before last one of our Directors and me were at Supply Side West in Las Vegas.  This is an event we attend each year to keep abreast of developments in the industry including the regulatory ‘landscape’.  This year a big issue was the proposed NDI’s. Industry organizations had ‘banded’ together to have an open ‘town hall’ discussion about it.  Dr Daniel Fabricant, the architect of the NDI’s from the FDA was also a participant.

    Dr Fabricant seems like a nice enough guy but he appears to be very inflexible and certainly got a ‘roasting’ from the industry spokespeople and the participants from the ‘floor’.

    One of the participants from the floor was particularly interesting.  He was a professor from an LA University and obviously a very knowledgeable person and he spoke a lot of common sense.  The main message he got across as a food scientist was that the proposed rules as they outlined by the FDA will be impossible to comply with…simply because the technology is not currently available to do what they are asking.

    He proposed that the FDA set up a scientific committee consisting of their own scientists and scientists representing the industry and between them work out a set of regulations that will achieve both the objectives of the FDA and the industry.  All responsible manufacturers want to ensure that their products are safe and effective and have no problem with the principle of NDI’s but not in the form that are proposed.

    This person also got a good laugh and clap from the audience when he asked Dr Fabricant why the FDA doesn’t focus their resources on the areas that are truly killing people…pharmaceutical drugs!  As expected Daniel stayed silent.

    Anyway, the take home message from what we learnt in LV was that the NDI proposal has opened up a can of worms which I feel that the FDA may be regretting in that the modifications are going to be major.  There are a lot of competent people in industry who are going to fight this tooth and nail so as a consumer I would not be too concerned at the moment as I am sure that the final guidelines are going to take some time and will be significantly modified…but, that is just my opinion, and a slightly optimistic one at that.

    I will keep you in the picture as this saga unfolds.

    7 Responses

    I hope you’re right, that FDA will regret opening up the can. But recently I learned that the public comment period for the NDI has been extended, I believe it’s for another 60 days. The worrying thing is that the period was extended at the request of the anti-NDI folks — in other words, the good guys. This suggests that not enough pro-supplements groups and individuals have registered their protests.

    I do agree that the final outcome will be well into the future, no matter what it is. But it is a worry. I just wish the whole thing would go away … along with the FDA.

    Thanks for the update.

    Gail October 27 2011

    Ha! The letter Lee received from his senator is the same one I received from mine (2) in NY. If I had saved these I would post them but unfortunately I deleted them some time ago. It is clear it is a "canned" letter (typed up and sent by their secretaries) telling us a story that is probably not true-that they don’t care what we think but are only interested in there electoral positions. Election day is on the horizon and we should tell them how we feel by voting them out!

    kevin October 28 2011

    Here is my response from Massachusetts Senator Scott Brown on my concerns on post 1994 new dietary ingredients impact:

    "Thank you for contacting my office regarding the Dietary Supplement Labeling Act (S. 1310).  As always, I value your input on all issues and strive to keep you updated on the important issues facing us today.

    Senator Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act on June 30, 2011.  This bill would give new authority to the Secretary of Health and Human Services to regulate dietary supplements that could pose safety risks to consumers.  Specifically, S. 1310 would authorize the Food and Drug Administration (FDA) to work with the Institute of Medicine to compile a list of potentially hazardous dietary supplement ingredients and develop new warning label requirements for supplements containing those ingredients.  This legislation would also require dietary supplement manufacturers to register all of their supplements with the FDA and to amend their labeling requirements with respect to the new regulations.

    As you may know, the Dietary Supplement Health and Education Act [P.L. 103-417] was signed into law by President Clinton in 1994.  Under this act, dietary supplements do not need the approval of the FDA, except in cases of a new dietary ingredient, where pre-market review is required by law.  I understand your concern that S. 1310 could create unnecessary red tape and place excessive burdens on dietary supplement manufacturers, particularly as our economy is still struggling.

    Currently, S. 1310 is under review by the Committee on Health, Education, Labor, and Pensions.  While I am not a member of this committee, should this or related legislation come before the full Senate for debate, I will consider it with your concerns in mind.

    Thank you again for sharing your thoughts with me.  If I can be of further assistance, please do not hesitate to contact me or visit my website at www.scottbrown.senate.gov."

    Lee October 28 2011


    I think your "optimistic" perspective is rather naive.  In fact, your words are almost a repetition of the thinking out of my Canadien friends several years ago about proposed Canadien supplement regulations "that would never, never occur in free thinking Canada."

    In case you don’t know, both Mexico and Canada define supplements as "drugs".

    In Canada, since 2004 any supplement has to go through a "pre-market" review" bottle neck…which has conveniently eliminated about 50% of the supplement introductions…with the focus on such "concerns" as claims made for Vitamin C and creatine in labeling. Obviously, the hurdles don’t stop there for anything imported from dirty old USA.

    In the USA, the FDA and FTC have been at this game for several years…nothing really new in their effort to support and promote prescription drugs…witness the monumental explosion of Medicare D costs in the USA as the proverbial "cure all.".

    You sound like you are way out of touch.

    HMM October 28 2011

    How can someone who has attended a presentation from the author of the proposed NDI change in conjunction with other supplement manufacturers, who spends their day looking at the implications of such proposed changes be classified as "way out of touch"?

    Warren please do not let this form of detraction from those who clearly appear not to have the same insights as you knock you from keeping us up to date, thanks for the insight, and I for one trust your judgement.

    Leigh October 30 2011

    Hmm…I really don’t think that I am out of touch.  Although there are some parallels in this situation with Canada there are also other aspects that were not present in Canada.  This is much more than a pre-market approval.   Canada’s system is simple and inexpensive compared to what the FDA are attempting.  There are substantive grounds for legal challenge in what the FDA are trying to do.  Let’s see how it evolves.  Through our US industry memberships we are kept informed.

    Warren Matthews October 28 2011

    SO what FDA actually wants from manufacturers?

    What is the ideal multivitamin according to new FDA requirements and does anybody make it at this time?

    greg November 06 2011

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