Dec __, 2011
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Draft Guidance for Industry; Dietary Supplements New Dietary Ingredient Notifications and Related Issues (FDA Docket No: 2011-D-0376)
Dear Sir or Madam:
I submit the following comments to the Record on FDA Docket No: 2011-D-0376.
While Congress asked that the FDA clarify the existing New Dietary Ingredient (NDI) regulation established in 1997 as a result of the 1994 Dietary Supplement Health and Education Act (DSHEA), the draft Guide Document is fatally flawed and needs to be retracted in its entirety. The following points are a few of my concerns:
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This guidance document if finalized as written will have a number of far-reaching effects on industry and the marketplace.
Consumers, like my family, and me are not well served by the resulting higher prices and reduction in some products in the market that surely will follow if industry is forced to comply with these overburdened proposed procedures.
As such, I call for the FDA to retract this draft NDI Guidance document in its entirety and craft a simpler, more appropriate guidance document in coordination with the industry and interested citizens.
Signed:
Name:
Address:
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- The extensive 86 page with more than 50 attachments NDI Guidance document is an attempt at “Rulemaking by Guidance Document” which is forbidden by federal law. It encroaches on the legislative and legal authority.
- The document proposes protocols that will result in higher consumer prices for supplements.
- Congress did not intend the guidance to be more limiting than the existing rule or to create ‘unreasonable regulatory barriers’ which this , if finalized in its current form, would certainly do.
- Throughout the draft guidance document, the FDA is setting the stage to pull the dietary supplement regulations closer to the drug regulations model, which is in conflict with the will of the American people and current law through DSHEA.
- The NDI Guidance document, if implemented as written, broadens the NDI scope of definitions and would create significant new burdens on the industry for any “new” dietary supplement, “new” meaning retroactive inclusion of 90% of the dietary supplements on the market today.
- These regulations will create many barriers for innovations in the Dietary Supplement industry and, in particular, deter smaller companies with fewer resources from protecting their formulas, ensuring a fair market share because of pre-market approvals and conducting more research than is actually necessary.
- The end result of passage of these regulations is limiting access by consumers, especially those with limited financial means, to quality products and adequate dosages without prescriptions and putting health care out of reach for many. This has happened in Europe and other countries and I do not want this to happen in the United States.
- The entire premise from which the FDA crafts this draft guidance document is fatally flawed from the fundamental crafty framing to herd supplements made from food into drug categories to an assumption that there is a problem in nature that has to be solved, to a focus on specific definitions and sections of the DSHEA to support its big pharmaceutical and big chemical company leanings in lieu of fair and balanced policy making principles for everyone.
- There appears to be an underlying attempt to create rules that regulate food-based nutritional supplements as if they were toxins, which not only restricts our abilities to choose natural approaches to health, but, represents a rejection of the entire history of human experience with nature and its life affirming nutrients.
- The FDA is creating significant burdens on both industry and the agency itself by proposing that an NDI notification will likely be needed for every product in since 1994 and any with a slight variation or modification.
- The FDA has erroneously limited the ‘marketplace’ language of DSHEA to mean only the marketplace of the United States. This is not what Congress stated; this is not a fair policy for the American supplement industry.
- There are likely products in the marketplace today that, if this guidance document is finalized as written, could lead to adulteration notifications on products that contain ingredients that were in the food supply in 1994, but were not confirmed to be in dietary supplements prior to the grandfathering in date.
- Products that contain ingredients marketed in supplements outside the United States, but not in the US, may be at risk for an adulteration NDI notification also with extreme and costly measures of proof at stake. Yet, there is no way to control foreign manufacturing processes or formulation – an excellent example being vitamin C where 90% of it is synthetic and comes from China.
- Products with probiotics may be eliminated from the marketplace under the provisions of the NDI Guidance Document. This has a special bleed through even to large industries where many types of chemicals are used similar to fertilizing in the beginning of the fermentation process yet never reported, labeled, or monitored. Transparence for one is transparency for all.
- The FDA’s proposed guidance document would trigger significant new NDI submissions when manufacturer processes are innovated or modernized from this date forward, as well as those from the past from 1994. Changes in manufacturing procedures or formulas trigger the need for an NDI Notice.
- Using a different part of a plant will require an NDI notification. Using a plant or herb at a different stage of maturation could trigger an NDI notification requirement.
- Heating up or baking ingredients could require an NDI notification as well any variations in temperature at different stages.- Changing the agricultural or fermentation conditions of the ingredients (such as sprouting or using a medium such as sodium selenite) could trigger an NDI notification requirement. - Drug Research May Keep Products Out of Dietary Supplements: The FDA’s current thinking on when a dietary ingredient is barred from being marketed as a dietary supplement is impractical on its face and would limit access to ingredients simply because a pharmaceutical company is considering drug development.
- The FDA suggests that a Citizen’s Petition would be required to market a dietary ingredient that has been part of a drug development program but is no longer being studied.
- The current thinking is that an article that has been authorized for investigation as a new drug or as a biologic before being marketed as a food or dietary supplement cannot be marketed as a dietary supplement if substantial clinical investigations of the article have begun and the existence of such investigations have been made public.
- A dietary ingredient could be barred from being marketed as a dietary supplement if the drug industry is researching a component
of the ingredient as an investigational new drug under IND.
- The draft guidance document is in conflict with the following provision of DSHEA: “…the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers…” and thus should be retracted in its entirety.
For entire NDI Regulations see http://www.federalregister.gov/articles/2011/09/09/2011-23098/draft-guidance-for-industry-dietary-supplements-new-dietary-ingredient-notifications-and-related
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