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Deadline for comment on dietary supplements is Dec. 2

November 23, 2011

By Susan Johnson
Copy Editor

Are you taking any vitamins or supplements as part of your diet?

The independent citizens health watchdog group Citizens for Health wants you to know that if you feel dietary supplements improve your health, you might soon find your choices greatly limited. Since the passage of the Food Safety Modernization Act (formerly S. 510), the Food and Drug Administration is assuming new powers to control what ingredients in which products may be considered safe to market to consumers.

It’s a matter of record in the Federal Register that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”

Though the Guidance is not yet binding, Daniel Fabricant, Ph.D., the Food and Drug Administration’s dietary supplement director, stated that there were “no surprises” in the directives. Citizens for Health, however, begs to differ. James J. Gormley, in his article, “A Defining Moment for the Dietary Supplement Industry,” wrote that on closer examination, “the FDA is willfully re-interpreting DSHEA [Dietary Supplement Health and Education Act of 1994] in several key areas but is fuzzy on specifics.”

At least one senator, U.S. Sen. Orrin Hatch (R-Utah), a chief architect and co-author of DSHEA, is alarmed by what is in the Guidance.

A brief recap: In 1966, the FDA announced that it would ban nutrient potencies over the RDA limits by reclassifying them as drugs, along with labeling restrictions that would forbid the inclusion of any useful information about supplements. At the time, the health-food industry sounded the alarm about the possible consequences. “Max Huberman rallied the industry and consumers,” wrote Gormley, and the outcry against the FDA temporarily halted the move.

Now, however, with the new regulations of the Food Safety Act, the Guidance looms ever larger and, to some in the health-food industry, threatening to their business. Not only would new ingredients be subject to stringent testing and review, but also currently marketed products, if their ingredients are prepared or distributed in a new way, such as cooking or cooling. In fact, one pet food manufacturer has already removed some organic products from their catalog due to the new Draft Dietary Guidance.

Comment from legislators

The Rock River Times asked for comment from both U.S. Sen. Dick Durbin (D-Ill.), who wrote the major part of the Food Safety Bill, and U.S. Rep. Donald Manzullo (R-16), who opposed it.

Christine Mulka of Sen. Durbin’s office sent us this statement: “The NDI Draft Guidance does not infringe on consumers’ ability to select supplements based on their individual health needs. When appropriate, it requires manufacturers to provide evidence of an NDI’s safety, and if evidence isn’t provided that the NDI is safe for consumers, the NDI can’t be sold to consumers. I would stress that this is DRAFT Guidance from the FDA, and Senator Durbin encourages any and all who are interested to comment.”

But Manzullo disagreed. Rich Carter, press secretary for Rep. Manzullo, sent us this statement from the congressman: “I opposed this legislation because it imposes significant regulatory and paperwork burdens and does little to enhance consumer safety. I am concerned this draft guidance places too much burden on dietary supplement manufacturers and could open the door to the FDA determining which supplements are safe enough to allow on the market, contrary to the intent of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994 (P.L. No. 103-417). In the DSHEA, Congress said that the federal government should not excessively regulate dietary supplements and that supplements should not be regulated in the same manner as medications.”

Citizen comments can only be made online. The link to the comment page is: www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0079.

Whichever side you come down on, remember the deadline is Dec. 2.

From the Nov. 23-29, 2011, issue

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