Beware of McCain's Freedom-Destroying Dietary Supplement Regulatory Bill

by Ann Shibler
JBS.org
Feb. 26, 2010

Most are familiar with those commercials on television promoting prescription drugs that supposedly offer relief from a variety of ailments, if one would only pressure one’s doctor to obtain them. They have become a source of great entertainment and amusement to some, the kicker coming at the end of each commercial when the FDA-approved medication’s obligatory litany of warnings and dangerous side effects is recited: “Tell your doctor if....” and “Side effects may include.....” Some of the warnings are mild like diarrhea and constipation, some list serious effects like cancer or tuberculosis, and others admit that sometimes even death can result.

The point here is that these are all FDA-approved drugs being advertised and used extensively. Drugs that can cause serious diseases like lymphoma. Drugs that can kill. The FDA’s dismal safety record is well documented; even PBS ran a Frontline special that investigated and exposed the FDA’s unsafe drug record, the influence of Big Pharma inside the FDA, and lack of long-term testing and medical review of many, many dangerous drugs. The FDA seldom removes a drug from the market even after it proves to be harmful or deadly, however they do post quarterly reports with details of the latest potentially dangerous side effects of drugs currently under investigation.

Nonetheless, Senator John McCain (R-Ariz.) wants this same FDA, with its dismal safety record, to regulate dietary supplements. The Dietary Supplement Safety Act (DSSA), S. 3002 (text of this bill posted on Senator McCain's website), that McCain has introduced with one cosponsor, would repeal key provisions of the Dietary Supplement Health and Education Act (DSHEA) to “more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”

Under attack by the DSSA is the once-protected field of supplements, as they have always been considered food. Potencies would have to be reduced to comply with what appears to be a plan modeled after the European Food Safety Authority. A new list of “Accepted Dietary Ingredients” would be “prepared, published, and maintained by the Secretary,” in the future. That’s a bit like being handed a blank check and told to fill it out later as one wishes. It could certainly be used to severely limit access to, and even production of, hundreds of life-sustaining and essential mineral, herb, and vitamin products.

All ingredients contained in each supplement would have to be disclosed at the time the company registers all of its “manufactured, packaged, held, distributed, labeled or licensed,” products with the FDA. An onerous burden would be placed on the shoulders of suppliers and retailers of dietary supplements, as they would have to “obtain written evidence” from the seller that the product is registered as required by law, and keep that documentation on file. Monetary penalties for non-compliance “may, in addition to other penalties imposed in this section, be fined not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of such dietary supplement.” Those are very broad dictates and most likely subject to even broader interpretation.

The McCain bill would change existing mandatory serious adverse reporting regulations, requiring minor adverse effects to be reported as well so that the FDA could arbitrarily pull supplements off the shelves or reclassify them as drugs. This immediate recall authority would be granted to the “Secretary upon determination,” that there is a “reasonable probability” that the product is “adulterated” or “misbranded.” Adulterated in this bill takes on a whole new expanded definition: “A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety.” The development of new products that contain newly discovered nutritional components may be entirely quashed.

The hypocritical contrast between the regulation of drugs that can kill and the proposed hyper-regulation for food products -- vitamins, minerals, herbs -- is as plain as the nose on everyone's face.

A Pandora’s box of intended and unintended legal complications and government harassment of nutritional supplement manufacturers and sellers could very well be unleashed if this bill is passed. There are already existing laws on the books that protect consumers from misbranded, fraudulent, or contaminated products. Granting the FDA additional regulatory authority over nutritional supplements seems a bit suspicious, especially considering the influence the enormous pharmaceutical industry has wielded over the research, development, and approval process inside the FDA. Let’s face it, the FDA has been no friend and often has been positively antagonistic toward the nutritional supplement industry. Therefore one wouldn’t set the wolf to guarding the sheep without dire consequences.

In this perverted overly-regulated country, food is now toxic, and drugs and chemicals are safe for ingestion, no matter the harm that results. This inversion should remind us that those who best have the consumers health and safety interests at heart are the consumers themselves. It is big government that has a proven track record of not protecting the public. And it is big government that is seeking to take away yet another individual freedom, the right to choose one’s own treatment. (Where is the pro-choice crowd on this one; the ones that claim, “my body, my choice?”)

Contact your federal legislators and urge them not to cosponsor, support, or vote for such a power-grabbing, bill. Let them know Americans want unrestricted access to nutritional supplements, and the government out of their health choices.

Sen. McCain described his bill as a “no brainer.” For constitutionalists it’s a “no brainer” that it should be rejected for the dictatorial, power-grabbing, choice-limiting attack on the nutritional marketplace and individual freedoms that it is.