FDA vs CAM (Urgent Action Required)

The Food and Drug Administration (FDA) has posted its intention to put out a document on guidance on how they intend to regulate Complementary and Alternative Medicine Products (CAM) under the existing laws on the books. (The Food and Drug Act (Act) and the Public Health Service Act (PHS Act). One could presume that a clarification of this issue might be a good idea, but it appears that this is just another attempt by the forces supporting Big Pharma and allopathic medicine to regulate everyone else by declaring things are not medicine as "Medicine" and thus regulating them.

2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability
FR Type: Notice
Action: Availability.Guidance.Level 1

SUMMARY: The Food and Drug Administration (FDA, we) is announcing the availability of a draft guidance for industry entitled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." In recent years, the use of complementary and alternative medicine (CAM) products has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("the Act") or Public Health Service Act ("PHS Act"). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the Act or the PHS Act.

The Docket Notice is posted here.  The actual document is posted here.  I recommend that you download it and read it before preparing your comments. You can post your comments here. COMMENTS ARE DUE BY April 30 (actually they are legally required to allow more time because the clock doesn't start until they actually Publish the notice in the Federal Register, not on the date they approve it for publication--but this is the Bush administration, so it's not even worth mentioning that point--just get your comments in by APRIL 30!)

Response to this document from others

There has generally been a concerned response to this document among the blogosphere and alternative health sites. A cross section of the response is capsulized in the comments section to this Daily Kos Diary. There is more information available at the Democracy in Action Health Freedom Solutions site here, and they have a petition form that you can sign there to become a co-signer of their extensive legal brief that is in the little box at the bottom of the page. I urge you to sign this if you agree with it.  However, it is generally more effective, in responding to documents such as this, to write and post your own comments in your own words. [Nothing prevents you from doing both].

So what does this document do?

The purported purpose of this document is to give "guidance" to citizens regarding the application of existing laws and regulations to the "groups of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."  It uses the classifications defined by NCCAM (biologically-based practices, energy therapies, manipulative and body-based methods, and mind-body medicine), defines a fifth domain of "whole medical systems", and discusses how these may be regulated as cosmetics, devices, dietary supplements, drugs, food, and food additives. They also state that CAM products are not exempted from regulation. In footnote (3) they state emphatically that mention of a CAM product of method in this document "should not be construed as expressing FDA [approval] of that particular [practice] or [that it] is safe or effective for its intended uses of safe for use."

The document goes to some length to define in detail how their regulations might apply to the various modalities (called Medicine by them) and what authority they have under existing law or regulations to regulate the modalities or their components. I'm not going to go into these in detail here (you can download the document and read it yourself here --a duplicate of the link above) but I will try to explain how it might apply to you and me in the following section.

How does this apply to aromatherapy and perfumery?

To the extent that perfume is a cosmetic (applied to the human body in any way, several of which are defined, for "cleansing, beautifying, promoting attractiveness, or altering the appearance") is definitely can be regulated as a "Cosmetic" so I won't talk much about perfume (for if perfume is used for treating something it is probably more accurately defined as aromatherapeutic).

Holistic aromatherapy can be defined as a "whole medical system" and contains or utilizes aspects of the other four domains. Use of essential oils is a biologically based practice; when elements of Chinese medicine or homeopathy are considered we are using an "energy therapy"; massage therapy is certainly a "body based or manipulative" therapy; and because aromatherapy can have spiritual or psychological influences it is a "mind-body" therapy.  Although neither aromatherapy nor homeopathy are mentioned in the guidelines, we can rest assured that they intend that we are covered.  And if aromatherapy doesn't fit into any of domains we can be sure that it is included as a "cosmetic" if it touches the body.

If you want to understand in detail how they intend to apply the existing laws to regulate CAM and thus aromatherapy, you need to read the draft guidelines.  I'm going to rip through an interpretation of how tangled a mess it is, with or without the guidelines, as the FDA is currently proceeding:

If an aromatherapist makes any claims or diagnosis that an essential oil might be used to treat or affect a "disease", then the oil is a drug and can be regulated. If it is a "New drug" then it has to go through a costly approval process. If you use it in a "device" such as a diffuser, and make claims about it affecting a "disease" or of affecting "any function" of the body, then the device is subject to FDA approval. If you take an essential oil internally, then it is either a "food," a "food additive," or a "dietary supplement" and if you make any claims, then it can be treated as a drug. If the oil is on the GRAS (generally recognized as safe) list, then you can get by, but might still have to get premarketing approval.  If you can meet the definition of a "dietary supplement" then you can get by if you add the notice about it not being intended to have anything with disease, and if you word your marketing materials "just so" you can probably sneak by.  But it is a tangled web, particularly if we are trying not to deceive.

So what can we do about all this?

First of all, it is important to note that the laws that are referenced in the Guidelines are already on the books, and given the current political and social climate, it's unlikely that they will get repealed or even substantially changed. So what we need to do is attempt to influence the document via a massive public outcry.  The Health Freedom movement is trying to get the word out to as many people as they can.  Unfortunately a lot of people haven't understood the subtleties of how this is being put forward by the FDA. As Rima E. Laibow, MD and others point out, what the FDA is attempting to do is shift the definition of CAM from being therapy or a treatment modality to being Medicine. This is covered in detail in the legal brief they've posted here, but which is hard to read at that location. Since I haven't found it online in a readable location, I will post it below the fold in a new post here. I suggest that you read it, and sign and send it at their message sender here.  But then go to the FDA Docket site here, and make your own comments in your own words.

Remember, the deadline is April 30!