The Food and Drug Administration has extended until May 29 the opportunity to comment on a draft document called a "guidance" that spells out anew the agency's thoughts on regulating alternative medicine products and practices. Yes, they are back!
Stand-up groups like the American Association for Health Freedom and the National Health Federation, in addition to successfully asking for the 30-day extension, agree enactment wouldn't change the letter of the law as spelled out in two important provisions that influence the practice of alternative medicine - the Dietary Supplement Health & Education Act (DSHEA) and the Public Health Service Act.
But the two groups are urging alternative medicine and dietary supplement businesses to recognize the red flag and comment anyway.
While many consumers have already commented on the guidance, the document was issued for industry review, so the FDA will focus on comments from those types of businesses. Big Pharma will have plenty to say, also, so if you know folks at spots like Barefoot Herbs/Barefoot Kids, get them shakin'.
Most foul in the draft are repetitive references to alt med businesses being able to one day prescribe licensed drugs, the inference being that the dietary supplements these businesses primarily dispense are foods or drugs and thereby regulatable.
The fear is that portions of DSHEA are expandable to where the FDA could crackdown on therapeutic natural products by how it defines things like "good manufacturing practices" and also by how the agency decides it will conduct post-market oversight.
Alt med practitioners for now can stay safe by always acknowledging to their clients that products are being dispensed to improve general wellness and never for specific disease diagnosis, cure, mitigation, treatment or prevention.
Eventually, though, the real goon in the closet will be set free, that being a broadening of the definition of a drug so as to fit into an international framework similar to that now under creation by the European Union. The fear is that emboldened, newly-omnipotent regulators influenced by Big Pharma's bedside manner, would make anything that's not a food a drug.
Review the draft and submit comments at www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm. Written comments go to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room. 1061, Rockville, MD 20852.
Choco-Heresy, Or Is A Fat Just A Fat?
Under current FDA guidelines chocolate must be made with cocoa butter and, if sold as milk chocolate, with whole milk powder. So leave it to the shelf-stuffing lowballers at the Grocery Manufacturers Association (GMA) to ask the agency to redefine chocolate so that it can contain non-chocolate oils and milk by-products.
The lobby group and its associates have specifically asked to "use a vegetable fat in place of another vegetable fat named in the standard." The only "fat" currently in the standard is, of course, cacao fat, and any derivation in a product today means a label of "chocolate-flavored." You can only imagine how chocoholics have responded.
But buried deeper in the paperwork filed by the GMA are other troubling requests, most of which fall back on the food industry's hots for the cost-effective concept of ingredient interchangeability.
These include, but are not limited to, permitting processes that have the same effect as aging cheese (without aging the cheese), allowing things like spaghetti to be labeled as "whole wheat" even though the noodles were only 51 percent whole wheat flour and permitting the use of enzyme-modified egg yolk in place of egg yolk. Even roasted meat could be called as such as long as it had the appearance of meat that had been roasted.
Cinching in the circle of life
IU plant biologist Mark Estelle on May 1 became the 10th person in the history of the university to be named to the National Academy of Sciences, the official adviser to the federal government in any matter of science or technology. He did so while helping all of us realize that, as living creatures, we are all more closely related than we might ever imagine.
Helping Estelle reach this career pinnacle was his research recently describing a heretofore unknown regulatory system for hormone action in plants that plays a part in how they grow and develop. While identifying a new receptor, auxin, considered a missing link in this chain of development, Estelle also uncovered mechanisms that "revealed the existence of fundamental shared regulatory pathways in plants and animals, including humans," according to the announcement.
So now you have it from the National Academy of Science's Estelle: There really is something to all of that tree-hugging.
Steve Chaplin can be reached at sjchaplin@sbcglobal.net.
