The following is my letter submitted to the FDA who is proposing certain regulations to impede, restrict, and ban dietary supplements – natural plant extracts, herbal formulas, probiotics, etc. are all affected. This has happened in Europe and other countries. Fax your letter today. Click here for the full scoop.
November 30, 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RE: Draft Guidance for Industry; Dietary Supplements New Dietary Ingredient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:
As a health educator who advocates whole food-based dietary supplements and organic raw foods to promote optimum health, I submit the following comments to the Record on FDA Docket No: 2011-D-0376.
The extensive NDI Guidance document goes too far with its 86-page document with more than 50 attachments. The premise is fatally flawed and not health based and proposes protocols that will result in higher consumer prices for supplements, which will inhibit our healthy lifestyle programs, especially for many of my clients and for other health practitioners and educators across the country. It should be retracted in its entirety.
Below are a few of my major concerns regarding this proposal:
Fatally flawed and Not Healthy: The entire premise from which the FDA crafts this draft guidance document is fatally flawed. The FDA is focused only on the definition of New Dietary Ingredients rather than the entire description of supplements, put into law by Congress. Existing laws, such as DSHEA, are already in place – use these and don’t duplicate.
For instance, the dietary ingredients in supplements we use are made from real organic foods that have been consumed for millennia as nature intended. In the NDI, if the ingredients are different from any original product prior to 1994, for example an isolated molecular variation, a new blend of food particulars, different modern computerization or technology practices in manufacturing, or even a different target consumer population itself, every company and supplement is subject to an NDI submission. Nature is not “grand-mothered or grandfathered” as it should be. Bottom line, it’s all food and there should be no extra costly notification required just for mixing ingredients differently.
Further, the intention of a guidance document is to provide clarity regarding regulations; yet these are moving towards a “you need my permission” to formulate a supplement this way rather than a “tell me about it” reporting. If one of these elements has not been marketed as a supplement, it would be considered an NDI. These regulations and notification processes are way too many and too costly.
Shifting towards a Drug Model
The perceptions of the FDA being a revolving door for the Mansanto culture appears to be coming true. The NDI process mirrors the multi-billion dollar drug pre-market approval process. Not just the levels of reporting but the costs of justifying the effectiveness of a supplement snares a small producer or manufacturer into a drug level of justification. Chemical development requires so much more money and research because of the need to prove that the chemicals are better than or equal to nature. It can take millions to get a drug to market and possibly now millions to get supplements on to the market – if a small company can hold on to its formulas before Big Pharma or Big Chema pirate them and patent the formulas, before they can get it to market.
The FDA places the responsibility for presenting an alternative method of validating an NDI on the shoulders of the submitter (manufacturer or distributor). Only those with the big bucks will be able to do this and therefore control the supplements. This level of “justification” is detrimental to the fundamental rights of American enterprise.
Burdensome and Crazy Retroactive: The NDI Guidance document if implemented as written broadens the NDI scope of definitions and would create significant new burdens on industry for any “new” dietary supplement; and, “new” is considered any supplement created after 1994 –which is about 90% of what is on the market today. This is a crazy-making Pandora’s box of justification and gathering of evidence; all of which and will create many barriers for innovations in small businesses. In these economic times, the choice will be clear – do not produce the supplements. What we have today will not be available tomorrow, as has happened in Europe.
Submitting NDI notifications with lengthy evidence, creating research or manufacturing duplications and extra forms, which will drive the cost of bringing a product to market higher. The end result is limiting access by consumers, especially those with limited financial means, and putting health care out of reach
This guidance document if finalized as written will have a number of far-reaching effects on industry and the marketplace. Consumers such as my clients 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 overburden some proposed procedures.
In my business, I know that more than 75% of the illnesses, especially chronic health conditions that most Americans are living with are directly related to diet and lifestyle. Through the promotion of healthy lifestyles we can greatly impact and allow choices for people to become vibrantly healthy. Dietary interventions including dietary supplements are one of these key choices and the first line defense to many life-limiting conditions.
I am weary and distrusting of a regulatory agency that already focuses on implementing regulations to insure the safety of the food supply including dietary supplements and yet wants to extend it arms reach deep into our personal choices with over burdensome regulations to affect our food and supplement supply.
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.
20 Sunnyside Avenue
Mill Valley, CA 94941