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Category: FDAFederal Government AffairsNews Releases

MUCH ADO ABOUT NOTHING Let's Get the FDA/CAM Issue Put to Rest
April 27, 2007


MUCH ADO ABOUT NOTHING

Let's Get the FDA/CAM Issue Put to Rest

April 27, 2007

The greatest threat to a totalitarian movement, once it gains power, is factuality.
                                                                                                                                          Hannah Arendt: Prophet for our Time

Refined Guidance Response
By Lee Bechtel, NHF Lobbyist

The National Health Federation is hearing from folks and is aware of what other groups are saying about the FDA Guidance for Complementary and Alternative Medicine Products issued by the FDA on February 27, 2007.

As the NHF lobbyist, my style is to work from the facts.  In dealing with Members of Congress, their staff, and FDA personnel, credibility is the only stock in trade.  And, things do get around to people involved in FDA issues in both places.

Currently, several groups - other than the NHF - are circulating news about the "end" of dietary supplements and ability of medical professionals, State-regulated or not, to practice Complementary and Alternative medical (CAM) professions, as we currently know it to be the case.

What is being consistently lost in the issue translation in these messages is what the proposed Guidance really means, to CAM providers and consumers, the intent of the Guidance, and the federal and State medical regulatory processes in place that will not mean the "end of the world" as we know it.

The Guidance as drafted does not prevent access to CAM providers.  It does not prevent the use of supplements/herbs etc. by medical professionals in their practice, with limitation, nor does or would it directly impact consumers/patients. It would not prevent the use of healthy foods in a diet recommended by a doctor.

What the Guidance does do is present current FDA thinking on how CAM fits within the current context of FDA food and drug regulation. Again, Guidance is not a regulation, nor is it a law. It confers no legal impact on the FDA or the public. Guidance specifically relates to FDA thinking on the design, production, labeling, promotion, and manufacturing of regulated products.  In this case, products related to CAM medical practice. This includes FDA-regulated drugs, supplements, and potentially foods, with severe restrictions.

Some groups have raised the concern that the Guidance would cause problems with a CAM practitioner treating patients, in the confines of their office, with a food, and recommending a food (in this case orange juice used as an example) that would be translated into a drug. Specifically, that a CAM practitioner "prescribing" a natural food to treat a medical condition could lead to FDA action.  The same logic is being applied to dietary supplements.

A few facts.  First, a CAM practitioner cannot "prescribe" a food in any event under State or federal laws, because natural foods are not regulated as drugs. Foods appear nowhere in the classifications of drugs, regulated by the FDA and the various States. Dietary supplements are also foods. A CAM Medical Doctor could be employing "off-label" uses of FDA approved drugs for patient treatment, which includes a combination of supplement and natural foods.  Prescribing, within the office, only applies to the drug. There have been attempts, and will be attempts, to blur the line between supplements claiming a curative or preventative outcome and their classification as a drug by the FDA. Recommending foods and supplements is not, under federal law and most State Medical Practice Acts, "prescribing."

A question has come up and relates to why CAM practitioners should not be allowed to "practice off-label uses for dietary supplements"? This is a completely implausible situation, for the time being. The FDA and its counterpart State agencies - unless and until Senators Durbin and Congressman Waxman get their way - regulate supplements as foods. Yes, there are State FDA agencies not officially affiliated with the FDA. But there are no federal or State "on label" curative uses for foods. There is FDA regulation of food-labeling claims, such as that a cereal helps the consumer reduce cholesterol levels or lose weight. Without specific FDA approval of "on label" requirements for specific preventative, mitigative, or curative disease or conditions for specific foods, however, there are no "off label" matters for the FDA to regulate.

On the fear that the FDA will go after MDs practicing CAM - keep in mind, that physician/patient medical records and communications are protected by the federal HIPPA law. If the FDA wanted to go after a CAM practitioner, based on evidence of using a CAM treatment regime, they could not get evidence, without violating this law. The FDA would have to get a patient's written consent to release records.

A person could file a malpractice complaint with a State licensing board, if the CAM profession is State regulated, and then the FDA could get this public information.

This is the case unless a CAM medical treatment goes beyond an office setting and is advertised for whatever purpose to the general public as a treatment/cure for a condition. In the eyes of the FDA, it becomes marketed as a  "drug," even if there is, in fact, only one drug involved, either on-label or off-label use, used in the combination comprising the CAM therapy.

This point is important and has been around since the creation of the National Center for Complementary and Alternative Medicine (NCCAM) in 1998. This creation is, in my view, the basic reason for the Guidance.

Could there be Guidance transference to States and their regulation of CAM practitioners?  Sure, but the Guidance and the federal Administrative Procedure Act (APA), Code of Federal Regulations, provides legal protection.

On this point, the Guidance does raise the issue of how far the FDA can or would go to preempt State medical-practice laws for licensed CAM professionals. However, FDA Guidance is not federal regulation, as is stated in the APA. However, State Medical Boards going after physicians who practice CAM is an ongoing issue, with exception for several States. This is because there are no clarifications/exemptions specified for CAM practitioners who are MDs and DOs. Naturopathic Doctors (NDs) are licensed in 12-13 States, but, for the most part, are not granted drug prescriptive authority.

Federal preemption is a concern, but the Congress has not allowed this in the past.  Clearly, these are State issues and not directly related to anything the FDA could do, unilaterally on it own.  So, this is simply another fear based on speculation and not on the facts. The FDA does not, and cannot, regulate the practice of medicine/healing arts at the State level of government, within the confines of a CAM provider/patient relationship. This is not my interpretation. It is spelled out in the Food, Drug, and Cosmetic Act (FDCA).  This applies unless or until a person, a company, a partnership of both, or anyone else goes public with a CAM treatment that infers that the combination therapy would prevent, mitigate, or cure a medical condition.

Remember, the FDA Guidance only reflects FDA thinking. And, that their bureaucrats and the law and regulations are so out of date with the current practice of medicine that we are where we are when it comes to the Guidance issue.

Process Lost in Translation

Some groups have taken the position to specifically file comments on the interpretation of CAM used in the draft Guidance document. Others are asking members to send letters to the FDA requesting an extension in the filing deadline, and suggesting that Members of Congress should be lobbied to write letters to the FDA to grant a deadline extension.

There are, in fact, two levels of FDA Guidance. In the current case, this is a Level 1 Guidance. This means that that document sets forth its initial interpretations of statutory or regulatory requirements to guide FDA bureaucrats, and the public, when a complementary and alternative medical treatment is claimed, in the public domain, to prevent, mitigate, or cure a type of disease or condition - in other words, when making a drug claim without FDA approval.

Unfortunately, none of these messages have placed the issue in the context of the real world of public policy, and federal and State regulatory process. To be clear, this outlines the current federal Administrative Procedure Act, applying to the FDA and its "Good Guidance Practices." The CFR/APA citation is Title 21, Section 10.115. People may read this section for themselves, if they want. 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115&SearchTerm=good%20guidance%20practices

The FDA is not required to review any comments sent in before issuing a Level 1 Guidance. There is a reason. They have to publish notice and they can request comments, but are not required to respond. If they do, this helps with the bureaucratic learning curve. Asking Members of Congress to ask the FDA to extend the deadline is an idea, but I seriously doubt there will be any takers. There is a reason, see below.

The FDA is required by the APA to review comments and suggestions for revisions on any Guidance document issued by the agency, at any time, for either Level 1 or Level 2 Guidances issued by the Agency, from any groups/people. So, the draft Guidance is not, even if published in its proposed form, the end of CAM or the use of supplements, as we now know them to be.

Finally, after a Guidance is finalized, the FDA can issue a Compliance document. This provides more specificity on what the FDA meant when it issued a Guidance.  And, this would also be open for public comment, and so forth.

As the NHF lobbyist, I suggest that all of the players in the health-freedom community need to keep an eye of what the FDA is really doing.

Spreading fear and misinterpreting the facts, in virtually complete ignorance of FDA processes and without having done the simplest of basic legal research does not inform people, nor does it do anyone in the health-freedom community any good.

This is not about protecting the FDA. It is not about an FDA conspiracy. It is about reliable information and experienced analysis to be more informed about what Congress and the FDA are doing that really impact health freedom of choice

I would also counsel that people should ask themselves WHERE these other groups were when the NHF was actively lobbying Congress against passage of the AER bill last December. The answer - Nowhere to be found. Lost in action!

I would also suggest that the players in the health-freedom community be more concerned about when the FDA issues a Guidance when implementing the AER law.

This applies to consumers and supplement manufacturers as well as CAM medical professionals. This event will be serious and will deserve grassroots participation from all parties involved. This will happen at some point because it is written into the law. Stay tuned to the true facts and situation. Don't be a lemming and jump off the deep end just because some misinformed people point the way off the cliff. Let this be a lesson to avoid listening to them in the future.

This Guidance and clarification actually dates back to the FDA's Strategic Plan in 2000/2004, but it has taken them until 2007 to produce this draft Guidance.

**************************************************************

Supporting this position, veteran food-and-drug lawyer Todd Harrison of the Washington, D.C. law firm Venable, says "the FDA's CAM Guidance document does not contain anything new. Indeed, FDA has long taken the position that if these products are marketed to cure, treat, mitigate, diagnose, or cure disease, then the products are subject to FDA's regulatory authority as a drug, biologic, or medical device. The document stops short of stating that FDA has the authority to prohibit a practitioner from using a lawfully marketed food, dietary supplement, cosmetic, or device to treat or prevent a disease."

About the 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 government restrictions. With consumer members all over the world, and a Board of Governors and Advisory Board containing representatives from 6 different countries, the Federation is unique is being the only consumer health freedom organization in the world to enjoy official observer status with the Codex Alimentarius Commission.

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