A Guidance Document open for public comments over at the FDA came to my attention this morning. The comment period ends April 30, 2007 and I strongly encourage my readers to take a few moments today to submit comments along with some additional follow-up.
Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, Docket No. 2006D-0480 is as detailed and vague as it gets. It seeks to "tie up loose ends" many feel exist in current regulation around approaches used in Complementary and Alternative Medicine (CAM) by establishing guidance for industry about communicating benefits of a "wide array of healthcare practices, products and therapies that are distinct from practices, products, and therapies used in 'conventional' or 'allopathic' medicine."
The critical issues to think about:
1. The guidance document, if finalized as written, will regulate virtually all herbs and supplements as drugs if they actually benefit a medical condition unless it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
Not only that, but also...
2. The document, if finalized as written, is extremely vague as to the extent of regulatory reach. For example, the document states, as an example, that vegetable juice (yes, vegetable juice) "absent any claims that would make the juice subject to the drug definition, the juice would be a 'food' under section 201 (f) of the Act because it is used for food or drink for man."
Now earlier in the document, in an attempt to define how vegetable juice might be defined as a drug, it is stated, "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..."
So, with that, any person (or product) that states "drink some vegetable juice to prevent [insert disease]" is 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 company) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.
Vegetable juice, a drug?
Not only that, but also...
While it may seem unthinkable, consider this, as another blog highlighted, "[i]ts very specificity makes manifest fundamental inconsistencies and absurdities in the DSHEA law. If you substitute "water" for "cranberry tablets" and "severe dehydration" for "urinary tract infection," as found on Page 12, then you've turned water into a drug according to these guidelines. Obviously, the FDA would never turn water into a drug, but the guidelines allow them the option to do so. That "flexibility" alone makes the guidelines dangerous. In reality, what the guidelines do is extend the FDAs authority to arbitrarily decide when to enforce their will."
Not only that, but also...
The most alarming thing to me is the use of language throughout the document - the FDA sets the stage that anyone who is not a licensed healthcare professional (physician, nurse, DO, etc.) will be subject to prosecution for practicing medicine without a license because the terms used, "medicine" rather than modality, "treatment" rather than therapy. This is because of already established regulations and laws in all 50 states as to whom may "treat" medical conditions; these new regulations will specifically limit whom is able to communicate options to consumers to those holding a professional license. Any practitioner - homeopathic, naturopathic, reflexologist, Chinese or Ayruvedc practitioners, nutritionists, etc. - will all be at risk for practicing medicine without a license if they even suggest something like vegetable juice may prevent, treat or mitigate the symptoms of a disease.
Which brings us back to the vague nature of the document...the specific language - everything termed as medicine and treatment - leaves the very real potential that any and all substances - vitamins, minerals, herbs, co-factors, probiotics, etc - could be classed drugs, new drugs, or medical devices if they are being recommended to prevent, treat, mitigate or cure disease states (remember water cures dehydration).
While the media is silent on this, the FDA quietly awaits comments that few know are open.
Well, now you know and now you can let the FDA know what you think - because if we do not comment we'll have no one to blame when we lose access to the vast options available to us right now.
Here is what you can do to let your voice be heard:
1. Submit comments online. Be sure you include the Docket No 2006D-0480 with your comments.
2. You can also send comments via snail mail to:
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
3. You can call and chat up the following people and let them know what you think:
Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739
4. In addition to the above comment submissions, write or call your representatives and senators! You can find the contact information for your representatives in the House and Senate here.