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Category: ArticlesNews ReleasesFDAFederal Government Affairs

NEWS RELEASE

NO CLUE BILL -

NEW DURBIN BILL AND FDA GUIDANCE FOR DIETARY INGREDIENTS

SPARKS REVOLT

July 07, 2011


 

     Two dietary-supplement issues – one legislative and one FDA “guidance” – have hit Americans with a body blow recently that, if the idiots who are behind the legislation and guidance do not immediately withdraw their nonsense, will spark a political revolt in the Halls of Congress, the likes of which have not been seen since 1994!  And the National Health Federation will not be alone in this revolt.

The Durbin Bill

    On July 1st, Senator Dick Durbin officially introduced S.1310, the “Dietary Supplement Labeling Act of 2011.”  The more correct bill name would be “Dick Durbin Knows What Is Best for Consumers.”  Senator Durbin is selling this bill as his latest patent medicine that will protect consumers of dietary supplements by heaping on yet more FDA regulations.  He says that this will guarantee that consumers will have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients (i.e., not approved by the FDA).  As usual, Durbin is wrong and his “solution” will only harm the industry and consumers.

    This bill is nothing more than “Durbin III,” an attempt to impose more FDA control over dietary-supplement manufacturers, their marketing, and consumer access to supplements.  By piling yet more costly regulations onto the backs of companies, it will also favor the mega-companies (which can afford the lawyers and specialists to deal with such useless nonsense) at the expense of the medium- and small-sized companies (which cannot).  This is all part of the Durbin political agenda that pushes the “consumer safety” issue as a thin cover for pure greed and power – it is really all about protecting the drug companies’ monopoly over “cures.”  We are absolutely sick of it.

    On the surface, the Durbin bill tries to address the long-standing issue of the FDA not having a clear definition for “conventional foods.”  This would clarify which dietary ingredients included in conventional food products are foods and should be regulated as a conventional food subject to different ingredient safety requirements, and those which are used exclusively for dietary supplements and regulated under DSHEA.  This issue has been on the FDA's docket for at least 10 years.  Durbin clearly believes that the dietary-supplement industry and consumers should be on the hook for the failure of FDA bureaucrats to do their jobs.

    Under current law, it is the initial choice of a manufacturer as to whether a product is classified as a food or as a dietary supplement.  The distinction between dietary supplements and foods with dietary ingredient additives is not clear.  This has allowed some food products, i.e., beverages and energy drinks in particular, to be marketed as dietary supplements so as to circumvent the safety standards required for conventional foods.  The Durbin bill contains only one provision on this issue. The remainder of S.1310 proposes to:

  • Require dietary-supplement manufactures to disclose known health risks of individual ingredients and proprietary blends of ingredients used in products;
  • Display a warning on a label if the product contains a dietary ingredient that may cause a potential serious adverse reaction, drug interactions, contraindications, or potential risks based on a study conducted by the Institute of Medicine (IOM); and

  • Require the submission of safety studies and related published studies, to be reviewed by bureaucrats who are typically ignorant and inexperienced when it comes to dietary supplements.

    These provisions may look good on initial reading but are really serious flaws that are intended to give the FDA the authority to regulate supplements like drugs.   This will eliminate many safe products already on the market, increase dramatically the retail costs of others, and yet not advance consumer safety one iota.  Already, supplements are amongst the safest consumer products on the market – far safer than conventional foods, drugs, doctors, and hospitals, all of which are much more regulated.

    Keep in mind, too, that with regard to serious adverse events, the 2007 Dietary Supplement Adverse Event Reporting law has been in place, but the number of reports filed have not provided enough historical evidence on individual ingredients or proprietary blends of ingredients used in products to establish a fair and balanced evaluation by FDA bureaucrats.  It is no secret based upon past history that the IOM and its anti-supplement pool of scientists think that healthy foods and supplements should be regulated like drugs.  Finally, the FDA-issued industry Guidance for New Dietary Ingredients contains requirements that, if finalized, would mirror these Durbin requirements.  Is Senator Durbin seeking to codify into law this new Guidance and its requirements or were he and his staff out of the loop on what the FDA was doing?  In all probability, this is not likely; Durbin must have been coordinating with the FDA.

The FDA Guidance on New Dietary Ingredients

    By coincidence, on the same day, July 1st, as Durbin launched his legislative initiative, the FDA issued its own notice for its draft "Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."  This is a proposed guidance for supplement manufacturers and not a regulation that mandates industry compliance.  Again, it is another left-over DSHEA issue from seventeen years ago not addressed by FDA bureaucrats. (For FDA Guidance, go to: http://www.thenhf.com/files/pdf/Draft_Guidance_New_NDI.pdf. )

    On its own face, the draft Guidance raises many health-freedom and supplement manufacturer issues.  Under current regulatory language, companies are already required to file pre-marketing notification with the FDA for supplements and their ingredients with a new dietary ingredient  (NDI).  The product may be marketed after a 45-day FDA review period, even if the FDA does not  do an internal review.  So, who is not doing their job on this point?  Certainly not the manufacturers.  The draft Guidance does not specifically set industry standards for requiring drug-like clinical testing, but it does without doubt, interject this into the FDA's review and approval process.  The NDI Notifications Section (VI), subpart (B) lists 43 types of safety evidence that can be submitted to substantiate the safety of a new dietary supplement ingredient used in a product.  These NDIs are products marketed after October 15, 1994, the date set by compromise when DSHEA was passed.  There are other provisions dealing with the use of conventional food dietary ingredients in supplements, pre- and post-DSHEA.

    The NHF has been aware of and tracking both of these developments.  After close analysis of the Durbin bill and the draft Guidance, the NHF believes that the Durbin bill is redundant in all of its measures and should be opposed, as stated above and because it is a back-door "Durbinesk" move to repeal the protections granted under the DSHEA law.  The outline of S.1310 and the powers being granted to the FDA have all of the hallmarks of the FDA's ban on ephedrine alkaloid containing supplements.

    This may also be why it has no other Senate sponsors, to date.  It is crystal clear, in our view, that the draft Guidance for industry goes far beyond the original Congressional intent behind the DSHEA law of 1994.  For example, the Guidance says it will consider 25 years of widespread use to be the minimum to establish a history of safe use for a supplement.  So only a dietary supplement sold before 1986 would meet this standard.  Products on the market before 1994 were deemed to be covered by DSHEA without the necessity of meeting its requirements.  The Guidance contains guidelines for when additional animal or human safety studies are needed, and has recommendations for a Safety Testing Matrix for individual ingredients.  In other words, the FDA’s fantasy of applying expensive and totally unnecessary drug-like safety and clinical studies to new supplement products is being expressed in this Guidance.

    For these reasons, and many more, the NHF opposes S.1310 and the FDA's draft Guidance for Dietary Supplement New Dietary Ingredients. The NHF will be submitting written comments to the FDA within the 90-day window for doing so and we encourage all reading this to do the same.   Moreover, please send an email to your Senators opposing S.1310.

 

S.1310 Bill text - [Click Here]                              S.1310 Sample letter [Click Here]


To Submit "Comments" on the Draft Guidance:
  
To ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic, written, or faxed comments on the draft guidance within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit electronic comments to http://www.regulations.gov

This is the dockets management/regulations page for the FDA

Enter 2011-D-0376-0001 into Key Word/Document ID space

The notice for Draft Guidance for Industry: DietarySupplements: New Dietary Ingredient Notifications and Related Issues will appear in the box.

Click on Submit comment button and fill in the requested information that follows.

For individuals, this is a public comment filing.

People have 20 minutes to submit their comments.

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Submit written comments - re: ATT Docket # 2011-D-0376-001

Food and Drug Administration

Division of Dockets Management (HFA-305) 

5630 Fishers Lane, Rm.1061

Rockville, MD 20852  

*********    

Submit fax comments re: ATT Docket # 2011-D-0376-001 to FAX # 301 436-2639

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2375.

 

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Click here for the permanent link to this news release, use this link to inform others.

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National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.

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