David's Blog

This may be something you’re interested in: the adequate protection your health through regulated consumables: now, or in the future.

Last year, I wrote an article that outlined the FDA’s attempt to regulate CAM products, including massage therapy oils/consumables, to the Nth degree, mirroring Sweden’s [Medical Products Agency’s] current regulatory process for products on the shelves in their country.

Haven’t heard any more about it?

Well, here’s a recap of the article I wrote with some ancillary information you may be interested in reading. When you’re done, read on about a new initiative to reform the FDA – and understand how you can help yourself and the country’s regulation of food and drugs.

The Complementary and Alternative Medicine (CAM) industry has boomed over the past 10 to 20 years. Thousands of CAM products and services have flooded the market, in which there is also the same demand – and it only grows. The National Center for Complementary and Alternative Medicine reports that in May 2004, 36% of Americans, aged 18 or older, used some form of CAM product or service. This number is expected to increase dramatically over the next 10 years and beyond.

There is some concern in the general public, the CAM practitioner community, the bodyworker community, and the Food and Drug Administration (FDA) about the growing popularity of Complementary and Alternative Medicine and the implications for regulation of the consumable products that are an inherent part of the delivery of the CAM service. The FDA is proposing regulation by law of the industry of CAM by regulating the CAM products that are used by practitioners in the industry.

The FDA Stance. They state that in the interest of the safety of the general public that utilizes the services and products of the CAM practitioners, they are considering restricting use of certain types of products that are produced in circumstances that are not advisable or regulated by the FDA, a governmental agency acting on behalf of the Consumer. Click here http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf to read their Draft Guidance and reasoning on the subject.

The CAM Practitioner Stance. Most tissue-manipulation and energy bodyworkers use only their hands (and no implements or organic products internally) and external lubricants to manipulate the tissue through the skin of the client. There are other CAM practitioners (like nutritional counselors and holistic doctors) that prescribe nutritional supplements, botanical or essential oils, and dietary aids and foods, under which the FDA would like to categorize, label, and regulate the production of these CAM products. What “CAM products” will become is: difficult to find – less available if laws regulate what can be purchased; more expensive to purchase – because of less competition and the cost to produce the product under FDA regulation; more processed, less organic – because of the proposed pharmaceutical nature and process of the production of CAM products; and, the variety of products will be greatly diminished due to the origin of the products not being approved by the FDA to be legally prescribed or sold for use in CAM practices.

The CAM Client Stance. The general public wants to know what is in the products that are being used on their skin and inside their bodies. They are becoming more aware of the old adage “You are what you eat” and how true it is in regard to what ever a person is exposed or consumes. They have a right to understand and be able to choose the products they are exposed to or consume based on the latest information possible from a consumer group that acts on their behalf. The possible regulation by the FDA may: limit the types and variety of products available to the CAM Client thereby removing a choice, raise the cost of obtaining these products due to the regulatory nature of the production of the CAM products, increase the safety of the products being used on or in the bodies of the CAM Client thereby reducing the physical response to a product that has been untested for safety and effectiveness toward the condition it is meant to address, and possibly change the face of the products that will ever be available to the CAM Client based on the recommendation of their CAM Practitioner.

Your Stance. The FDA is accepting and registering public comment for purposes of survey and public record about their proposal. You have the opportunity to register your opinion for the record, and may do so here: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&. If you are concerned about the CAM products that are on the market today and want to voice your opinion to the FDA, you’ll need to do so by April 30^th, 2007, to be “on the record.”

There is a new movement, on behalf of consumers and the public affected by the current practices of the FDA, to bring to the attention of Congress the deficits the FDA places on the newest markets of drugs and CAM products; “new science.” The American Association for Health Freedom (AAHF) is leading a campaign to reform the FDA, starting with a petition that will be delivered to Congress.

To read what the petition is about and to sign it electronically or print a copy to send to your elected Congressperson, visit the AAHF online.

You are the “one more” signature closer to changing things…