AddThis Feed Button "Frequently Copied, Never Duplicated"

Friday, August 05, 2011

Discussing FDA Current Attack on Supplements

This is from a colleague of mine who is known as the "Vitamin Lawyer".

LEF, Citizen's for Health and other groups already have action established to contact CONgress to make sure this latest round of insanity and Big PhRMA's attack on your supplemnts is stopped.

Remember that currently the FDA is telling you that wlanuts are 'drugs'.
The amount of documentation and safety information that the Food and Drug administration (FDA) now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified the Dietary Supplements Health and Education Act (DSHEA) in 1994 and now establishes a process “ominously like the one for new food additives,” according to the Council for Responsible Nutrition (CRN).
CRN chief executive Steve Mister, in commenting on the Food and Drug Administration's (FDA's) long-awaited draft guidance on New Dietary Ingredient (NDI) notifications, said that the new NDI process now ‘sounds an awful lot like the food additive petition process.’
The Dietary Supplements Health and Education Act was enacted in overwhelmingly negative consumer and industry response to 1993 Congressional efforts to medicalize the supplements industry. It requires firms filing NDI notifications to establish a ‘reasonable expectation’ of safety, whereas those filing petitions for new food additives were required to demonstrate ‘reasonable certainty’ that no harm will result from use of the new food additive.
But if you look at the section on safety requirements in the new NDI guidelines and all of the studies that are now required, it now sounds an awful lot like the food additives petition process, which is exactly what Congress was trying to avoid.
“It is terribly disheartening to see the FDA going in this direction. They had a chance to create a workable system that would incentivize more companies to follow the law, use the NDI notification process and draw a line between responsible companies and those ignoring the whole process completely. “But instead they have come up with a document that stifles innovation and will deny consumers access to new products. We are terribly disappointed,” Mister added.
As to what now constitutes an NDI, the fact that changes to the manufacturing process, new solvents or new extraction methods could turn scores of old dietary ingredients, which were assumed to have been ‘grandfathered in’ under DSHEA into new NDIs was alarming enough. Ironically, the new requirements could force the industry to revert to extraction processes used nearly 20 years ago.
However, the fact that separate NDI notifications for supplements containing the same NDI are required if the supplement is reformulated in any way, and that notifications are required for finished products, not just ingredients, means that the FDA would be “flooded” with NDI submissions if the guidance were not revised.

‘Absolute nonsense with no basis in science’

A section in the new FDA guidelines claims that a synthetic copy of a constituent or extract of a herb or botanical is not a dietary ingredient at all – even if it is chemically identical to its ‘natural’ counterpart – as in the case of a number of higher dose vitamins, is particularly troubling, although not wholly unexpected.

The FDA recently argued that the synthetic organic compound, homotaurine, which was being investigated as a potential treatment for Alzheimer's disease, was not a dietary ingredient even though it is chemically identical to homotaurine from red algae extract. “Again, the FDA is defining incredibly narrowly what constitutes a dietary ingredient, but very broadly what is a ‘new’ dietary ingredient.”

Marc Ullman, with the New York law firm, Ullman, Shapiro & Ullman, which represents companies in the supplements industry, said he was particularly frustrated by this aspect of the guidance: “It really is preposterous, absolute nonsense, with no basis in science. If we’re talking about something that is chemically identical to a botanical extract, but is synthesized, there really is no rational basis for taking the position that it is not a dietary ingredient.”
from Natural Health News

No comments: