FDA Attempting to Regulate Dietary Supplements

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A new U.S. Food and Drug Administration (FDA) docket was published on the FDA website last month. The draft guidance, when finalized, will represent the FDA’s current thinking on complementary and alternative medicine (CAM). Docket No. 2006D-0480: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration [1] discusses when a CAM product is subject to the Federal Food, Drug, and Cosmetic Act (the Act) or the Public Health Service (PHS) Act.

Here’s the important part in the draft:

The draft guidance makes the following two fundamental points:
First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act.
Second, neither the Act nor the PHS Act exempts CAM products from regulation.

Now, I do believe there exists a number of problems with the “natural health” industry. Foremost in my mind are issues regarding supplement extraction and processing, quality, absorption and bioavailability – there are no mechanisms in place to address any of these issues and protect consumers. [Indeed, these are some of the many reasons I recommend scientific review and assessment of third-party research and independent clinical studies.] However, the FDA draft guidance wording is so vague with respect to the extent of regulatory reach, any product used in CAM therapy or practice may be regulated. From the draft:

… depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act. For example, the PHS Act defines “biological product”, and the Act defines (among other things):

Cosmetic;

Device;

Dietary supplement;

Drug, as well as “new drug” and “new animal drug”;

Food; and

Food additive.

According to the Act, “dietary supplements” include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances for use to supplement the diet by increasing the total dietary intake, and a concentrate, metabolite, constituent, extract, or combination of any ingredient previously listed.

It gets better:

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 intended 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.

Did you get that? The Act would allow the FDA to regulate raw vegetable juice if it were used as part of a disease treatment regimen.

Thankfully, the FDA has decided NOT to regulate mind-body medicine, such as relaxation, meditation or group support. No, really …

NCCAM describes mind-body medicine as focusing on “the interactions among the brain, mind, body, and behavior, and the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health” [13]. 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-behavioral therapies, group support, autogenic training, and spirituality” [14].
In general, CAM practices in this domain would not be subject to our jurisdiction under the Act or the PHS Act.

Needless to say, the natural health community has been up in arms about this. The flexibility of regulation the draft guidance allows the FDA is unprecedented and dangerous. Surprisingly however, the Organic Consumers Association (OCA) published this statement:

… after painstaking review of the FDA guidance document we have determined that the document does not call for any NEW regulatory or enforcement action, but merely clarifies existing ways that the FDA classifies (or “thinks”) about different types of products used in alternative and complementary medicine. After some discussion with our colleagues in the natural health freedom movement, we have decided that this document is not of any real significance.
This is not to say that we are happy with the FDA. We are NOT. Due to political appointees from the pharmaceutical and agribusiness industries, they’ve been asleep at the wheel with GMO, synthetic food additive, and pharmaceutical safety testing. It is high time they subject these products to the same type of rigourous scrutiny they seem to have for natural health products. And should the FDA decide to further target natural, non-synthetic health products, we will hit back with all our might.

The OCA statement really confuses me, because the entire issue stems from how the FDA wants to “think” about CAM products. The language used in the draft guidance is so broad that it would allow the FDA to regulate any dietary supplement that has any beneficial effect as though it were a drug. The draft continues:

… 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.

Regina over at Weight of the Evidence summed it up nicely:

The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using “treatment” rather than “therapy”; “medical” rather than “modality”; the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).

The FDA is accepting public comments on the docket until April 30th. Be sure to include the docket Number 2006D-0480 and submit your comments here.

For those of you interested, you can read the draft document in its entirety here.