Highlight HEALTH

I’ve been so busy the last few weeks I missed this altogether. Many thanks to Jenny, a Highlight HEALTH email subscriber, for bringing this to my attention.

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 The draft guidance, when finalized, will represent the FDA’s current thinking on complementary and alternative medicine (CAM). Docket No. 2006D-0480: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration [1] discusses when a CAM product is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The draft guidance makes the following two fundamental points: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 However, the FDA draft guidance wording is so vague with respect to the extent of regulatory reach, any product used in CAM therapy or practice may be regulated.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.

Recommended reading: Jon Barron.

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

References

1. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. U.S. Department of Health and Human Services, Food and Drug Administration. 2006 Dec.
2. Health freedom action alert: FDA attempting to regulate supplements, herbs and juices as “drugs”. NewsTarget.com. 2007 Apr 11.

Alfalfa (Medicago sativa) is native to Iran and was likely domesticated during the Bronze Age to feed horses arriving from Central Asia. It was later used in Greece around 490 B.C. as horse feed for the Persian army. The name alfalfa comes from the Arabian al-fac-facah, for “father of all foods”. A perennial herb, alfalfa was and is easy to grow, thriving in many varied climates throughout the world, and provides an excellent protein-rich food source for cattle, horses, sheep and other animals.

Alfalfa grows to approximately 3 feet and has blue-violet flowers that bloom from July to September. The parts of the plant typically used are flowers, leaves and sprouts. Principle known active constituents include chlorophyll, carotene, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, calcium, copper, phosphorus, manganese, iron, zinc, fluorine, electrolytes, isoflavones, coumarins, betaine, alkaloids, phytoestrogens and the antioxidant tricin. In addition to its high nutritional value, alfalfa has a fairly high protein content (18.9%), containing eight essential amino acids.
(more…)

Highlight HEALTH serves as an information medium to provide knowledge and understanding of dietary supplements, nutrition and health news. We evaluate scientific information, disseminate research results and educate readers who are seeking better health to promote an enhanced quality of life.

The information presented at Highlight HEALTH is intended for the general public, patients, healthcare providers and caregivers, and is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.

Improvement of dietary habits can be crucial for the prevention of disease and promotion of health. Similarly, vitamin, mineral and herbal supplementation can play an important role as diet alone is often inadequate to provide all essential nutrients. Along with diet, the elimination of household toxins can improve home health and have a significant impact on a person’s overall health.

Articles on Highlight HEALTH reflect the following:

1. Documentation and References: Health science, including research in nutrition, biochemistry, metabolism and medicine, are essential resources for determining the effects of nutritional supplementation. Published clinical trials are required for determining supplement efficacy and safety. Undocumented claims and hearsay are not acceptable for website publication. All articles presented on Highlight HEALTH include bibliographic citations and research article abstracts from published scientific literature.

2. Home Health: Your home should be the safest place in the world. According to the American Association of Poison Control Centers, 89% of poison exposures occur in the home and cosmetics/personal care products and cleaning products are two of the most common forms of poisoning for children under the age of six [1]. Most household cleaners contain toxic chemicals such as chlorine, ammonia and petroleum [2]. The Consumer Product Safety Commission has identified more than 150 chemicals in the home that have been linked to allergies, birth defects, cancer and psychological abnormalities [3].

3. Myths and Education: What you don’t know can hurt you. In the world today, it’s difficult to sort out the corporate propaganda from what’s best for you and your health. Unfortunately, much of the health advice and possibly care we receive is motivated by marketing objectives and individual profit. Educate yourself so that you can protect you and the ones you love.

References

1. Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System, American Association of Poison Control Centers, 2000. Quick Facts on Poison Exposure in the U.S.
2. Answers.com - chemical poisoning.
3. Dadd, DL. Home Safe Home. Tarcher, 1997.