Thursday, April 12, 2007

Stop the FDA from classifying CAM as drugs!

Regarding: Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf This proposal is in a public comment period. I believe that it goes too far in re-classifying natural products as drugs based solely on practitioner claims. While the concept of the FDA determining which regulations certain products or procedures fall into seems reasonable, the agency's attitude that they can call a vegetable juice product a drug just because someone suggests using it to treat a disease should be considered unreasonable. The FDA already has the power to regulate drug claims, but not to treat a food (including dietary supplements) or cosmetic item as a drug simply because of an unapproved claim or use. In other words, the act of claiming that a product can treat a disease is already regulated under current laws concerning drug claims on product labels or advertising. It is too confusing and illogical to treat an individual product sometimes as a food and sometimes as a drug, varying with the label claim, especially when the drug claim is already illegal. The FDA's given example of cranberries, which do have a biological function of helping to inhibit the implantation of new bacterial colonies in the urinary tract but do not actually remove existing colonies, is very misleading. Cranberries cannot be used to treat an existing infection, though it may aid the body in managing urinary tract health. The unapproved (and inaccurate) disease claim is already prohibited under current law (DSHEA), yet the FDA now proposes to regulate illegally labeled cranberry products as drugs if someone does make this illegal claim! The FDA did not propose that foods or dietary supplements be generally regulated as drugs and only be available by prescription. The agency is actually trying to prevent doctors from making drug claims for supplements and foods. Yet physicians can currently make off-label prescriptions for drugs! The distinction is artificial, and the drugs are the more dangerous products by far! Concerned citizens are encouraged to submit their own comments by the end of the month. I suggest stressing your strong support for health freedom, which includes the ability to freely access CAM services and products (including dietary supplements) without undue government interference. You may also wish to support CAM practitioners' ability to prescribe natural products without the FDA treating them as unapproved drugs. If the agency applies this same logic to other CAM modalities, the FDA's proposed enforcement of current regulations on licensed, credentialed health practitioners would be a disaster. The comment period ends May 29, 2007. Please send your comments to the FDA to oppose this new power grab: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA

1 comment:

Robert Bogatin said...

Neil, I whole-heartedly agree with you on this notion that confusion will be the end result, not to mention a possible flurry of new legal actions to set precedent. Consumers are my biggest conern. At a time when reading labels with some insight is paramount to making betterchoices, what message is the FDA sending when it is now willing to classify products with such cross-over?

Perhaps the largest motivator is their inability to actually enforce the expansive dietary supplements industry and need provisions to make immmdiate actions on the products that stand out.

Perhaps there is continued pressure from drug companies to secure a competitive advantage over supplements and are going to substantiate their presence and profit with clinical trials that natural products manufacturer's can rarely afford.

Excellent dshea language on your site by the way. It's good to see more and more practitioners stand up to raise the bar of quality for DSHEA compliance.

Many folks may find the law to be cumbersome, innappropriate or itself a ploy to keep supplements and other natural products off the market. I say indeed not, DSHEA is an opportunity for our industry to self-regulate and from within our own competitive system deliver the best products at the best prices we can, with a industry-wide customer satisfaction guarantee that information and recommendations are made with the best care.

I am very interested in more of your opinions on the subject and what you think the industry will do in response to ill-conceived addendums to a law that currently promotes safe and clear business conduct.

robert bogatin, BetterChoices
DSHEASPEAK.COM