And I’m not talking about Roids! The FDA is about to reclassify fruit and vegetable juices, herbs, foods and massage oils as “drugs” or “medical devices”. Of course not every single one will be classified as a drug, it depends on how well it works and what is claimed about it. The FDA wants control and “regulation” over anything and everything in the natural world that either effects or alters the structure of the body or is claimed as having any therapeutic preventative or treatment value for anything. That can and will include anything as natural and benign as fruit or vegetable juice being regulated and classified as a “drug” if they get wind of anyone selling or drinking it with the intention of it preventing or treating, well anything. According to the FDA, they control anything that “treats” the body and anything that does is a “drug” that ends up in their domain. It might not be so bad if they were actually a neutral and non-biased organization they are supposed to be and truly were the trustworthy authority on safety. They always claim it’s for the benefit and safety of the public, but the words and claims behind a food does not change it’s safety, effectiveness or chemical makeup. Like if a bottle of water said it relieved dehydration it would be a “drug”, yet it doesn’t make it any different or less safe, nor does it make it anymore of a drug or medicine.
While controlling outrageous and false claims is a good thing, these guidelines go way beyond that to gray out and blur the line on the subtlest semantics inferring the very same information. That would give them the excuse and authority they need to go after almost anyone they want. Shouldn’t such a strong definition as a “drug” be a little more objective? This is nothing new. The FDA has been sending warning letters and going after any natural retailer, spa, manufacture or farmer who mentions or talks about any health claims for years. They recently went after small Cherry Farmers and threatened to raid them for making health claims about cherries and mentioning studies on the health effects of consuming cherries on their websites.
What is different about these proposed CAM (complementary and alternative medicine) guidelines is that they lay bare all of their intentions and the extent of those intentions for total domination and regulation over natural health care and products and information that works. I think it’s a bit unrealistic and unattainable to apply the same guidelines and requirements for synthetic patented drugs to natural food. The people selling the natural products and foods will never be able to compete and actually have enough incentive, funding and profits behind it to go through the same regulatory testing and approval as a “drug”. Therefore, the only thing they can do is keep their mouth shut about what it does, including studies already involving the food that showed certain health prevention or treatment benefits. They even want to start regulating massage oils as drugs and massage devices or yoga props as “medical devices”.
Sounds bizarre and unbelievable? Here are some excerpts from their proposed guidelines they submitted in December 2006, right out of their own mouths. You can also download the full PDF of the document.
“Second, neither the Act nor the PHS Act exempts CAM products from regulation. 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 foods in the Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intented for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.”
“For example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as “dietary supplements” under section 201(ff)(1) of the Act if they were labeled for use to “maintain the health of the urinary tract” rather then “prevent urinary tract infections.” The cranberry tablets would be regulated as “drugs” under section 201(g) of the Act if they were labeled for use to “treat urinary tract infections” even if they were labeled as dietary supplements.”
“CAM products that use veritable energy fields in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals may be medical devices under the Act.”
“Under the umbrella of manipulative and body-based practices is a heterogeneous group of CAM interventions and therapies. These include chiropractic and osteopathic manipulation, massage therapy, Tui Na, reflexology, rolfing, Brown technique, Trager bodywork, Alexander technique, Feldenkrais method, and a host of others….
Manipulative and body-based practices focus primarily on the structures and systems of the body, including the bones and joints, the soft tissues, and the circulatory and lymphatic systems….
To the extent that manipulative and body-based practices involve practitioners physically manipulating a patient’s body, without using tools or machines, we do not believe that such practices are subject to regulation under the Act or the PHS Act. If, however, the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act, depending on the nature of the product and its intended use.”
“It states that mind-body medicine “typically focuses on intervention strategies that are thought to promote health, such as relaxation, hypnosis, visual imagery, meditation, yoga, biofeedback, tai chi, qi gong, cognitive-behavrial therapies, group support, autogentic training, and spirituality.
In general, CAM practices in this domain would not be subject to our jurisdiction under the Act or the PHS Act. As with the manipulative and body-based practices domain, however, any equipment or other products used as part of the practice of mind-body medicine may be subject to FDA regulation, depending on the nature and product and its intended use. For example, biofeedback machines intended to help a patient learn to affect body functions, such as muscle activity, are regulated as class II devices.”
Does this mean that all the gym equipment and meditation and yoga CD’s will now all be “medical devices” and regulated by the FDA? For all that exercise equipment does effect body functions and muscle activity!
You can also write or call them at:
Docket # (No. 2006D-0480)
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
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