FDA CAM Regulation Guidance
American Association for Health Freedom and the Health Freedom Foundation are very concerned with the FDA document 2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (read FDA Summary). The full text of the CAM Guidance can be accessed from http://www.healthfreedom.net. (Adobe Acrobat required).
A guidance like this is very confusing and there are legal issues that must be carefully examined and responded to in writing. Therefore, as a first step, we have officially requested the FDA extend the deadline for comment to July 31, 2007. The time the FDA has provided for comment is simply too short for something this complex and important. We are working with Congress to ask them to have FDA extend the comment period. Go to www.healthfreedom.net to read our letter to the FDA requesting an extension.
We wanted to clarify that much of the regulation proposed in the document has already been claimed by the FDA. For example, making health claims as it pertains to dietary supplements and foods is currently not permitted, and people who do so are vigorously pursued by both the FDA and the Federal Trade Commission.
While we have several concerns with the CAM Regulation Guidance, the two biggest are broadening the definition of "health claim" and the desire to pre-empt the states in the regulation of some health care issues.
Example: The document attempts to define how vegetable juice might be defined as a drug, "This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for food in the Act and FDA regulations...If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would be subject to regulation as a drug under the Act."
The FDA defines a drug as "...(B) articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.
What the FDA is stating is that they believe that any person (or product) that states "drink some vegetable juice to prevent [insert disease]" is actually making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or manufacturer) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.
Who is going to fund a $50,000 investigational new drug application to get carrot juice approved as a drug, or the follow-on millions in research dollars to conduct a study on the toxicity ($200,000) and efficacy of carrot juice ($3 million and up.) Keep in mind this would have to be done separately for any disease process carrot juice might have an impact on.
Why did the FDA create this document? There are a couple of theories. One is that the National Center for Complementary and Alternative Medicine (NCCAM) asked the FDA to "harmonize" with their way of thinking. Another idea is that importation of products (which is a major concern to the FDA) will soon be a top issue. Functional foods could also be a target (as forewarned by the FDA December meeting on functional foods - read about our response and presentation). Regardless of the why, we do know that the health freedom community was not consulted in the preparation of the document. Furthermore, the clumping of food, products, medical devices, and therapies makes for an awkward, confusing, and unconstitutional "way of thinking" and does not represent what is best for the consumer.
The draft guidance, when finalized, will represent the agency's current thinking on the regulation of complementary and alternative medicine products by FDA. Though it does not change the law, it does represent a potential major expansion on how foods, therapies, and products could be regulated. Of further concern, is that this document could be used by health freedom "opposition" and regulators to pressure Congress to change legislation. The language in the document gives us great concern and we cannot allow an agency such as the FDA to finalize the document in its present form.
The comment period expires on April 30. It has been our experience that citizen letters to the FDA during the comment period rarely have an impact on the FDA's decision-making process. This is important to know, since the appropriate response to this situation is not to just be busy (as in writing letters to the FDA) but to be effective. What the FDA has told us is that they want to hear from practitioner groups and trade associations. Remember, that the FDA officials are not elected and generally the wishes of the public fall on deaf ears.
The two things that are most likely to influence the FDA's actions as it pertains to the issues outlined in this document are: Members of Congress who have a variety of mechanisms for shaping the authority of the FDA. State Attorneys General who can threaten legal action if the agency tries to usurp the authority of the states in regulating health care activities within their states.
In consideration of the above, we are taking these actions: We are alerting our Congressional friends about this issue, and asking them to take appropriate action. We will notify you when it is time to write to these elected officials and make your wishes known. We have commissioned an extensive, legal response to the guidance that has the kind of technical detail the FDA bureaucracy wants (or actually DOESN'T want) to see as they strive to give this document the force of law. We are planning to communicate with the proper officials in each state to notify them of the potential for federal interference in state regulatory activities. If you do write the FDA, please send a copy of your concerns to your representatives in Congress. These elected officials DO care about your opinion and your voice matters. Go to www.healthfredom.net to contact Congress.
We believe the CAM Regulation Guidance would set the tone of the FDA in regards to functional foods; alternative medicine therapy, devices, and products; as well as dietary supplements and could help set the stage for future legislation that would restrict access. While public comments to the FDA by individuals are a course of action, we want you to be aware that fighting FDA's "way of thinking" will need a stronger course of action and we are prepared to follow though. We have fought the FDA before and have been successful.
There are numerous issues facing the health freedom community that need attention where your action can make a big different: a draft bill to restrict access to individualized/compounding medicine, the right of the practitioner to practice being threatened by individual states, and Rep. Dingall wanting to "kill" dietary supplements because they are a "snake" to be killed.
Please know that we are working diligently on the important issues facing the health freedom community. It takes both time and money and your financial support is greatly appreciated.
If you would like to submit your written comments to the FDA, please use one of the following methods
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20853
EMAIL: Click here or copy & paste this link: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?E C_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA
NOTE: No matter which method, be sure to refer to Docket No. 2006D-0480
FDA's Latest 'Guidance Document' on Complementary & Alternative Medicine
American Association for Health Freedom and the Health Freedom Foundation, April 19, 2007
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