October 6, 2011
Division of Dockets Management
U.S. Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”
Dear Commissioner Hamburg:
Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”
CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit and letter of DSHEA.
According to a July 7, 2011 report from your Agency, Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.
U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.
With this as a backdrop, we are certain that your Agency is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone – calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) – could reduce healthcare costs by over $24 billion.
These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on – it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.
THIS GUIDANCE DOCUMENT
Therefore, it is mystifying to us, and to many others, why your Agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this Draft Guidance.
It is likewise baffling as to why your Agency would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” and “what is a new dietary ingredient,” for example, as bases for what is obvious is your new and intended supplement and ingredient review and enforcement position.
Your Agency is attempting to drastically change the law by saying that finished product manufacturers must submit an NDI for every product that contains an NDI or whenever a formula is changed, if an NDI is present.
Your Agency is in disregard of the law, Section 413 [21 USC §350b] of DSHEA, which says an NDI submission is not required if “there is a history of use or other evidence of safety” supporting its inclusion, use and marketing prior to 1994. Instead, your Agency is proposing that NDI submissions be product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.
For your Agency to assert that newer technologies and improved processing and extraction methods would render ingredients as NDIs since these methods were not known prior to 1994 is akin to saying that meat-packing plants should observe the filthy and unhygienic practices that led to today’s modern food-safety system because these antiquated methods were approved then and these new processes are different.
Review and enforcement based on the re-interpretation of DSHEA expressed in the guidance would be expected to cause major disruption in the dietary supplement market, forcing a significant number of products off the market, resulting, according to estimates by a leading economist cited by another commenter, in revenue losses of over $1 billion dollars and causing the unemployment of over 100,000 Americans.
In the area of innovation, the direct result of policies behind this guidance would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from your Agency.
The American people would be harmed by the market and access implications within this document.
The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994. The harm would come from reduced consumer health in America as innovative, high-quality dietary supplements are removed from shelves or never see the light of day.
Your Agency’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law on the basis of this alone.
Neither American consumers nor the dietary supplement industry are going to stand for this unconscionable attempt by your Agency to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.
We call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.
James S. Turner, Esq.
Citizens for Health
James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health