• Newly Proposed FDA Safety Guidelines Could Remove Children’s Vitamins From Store Shelves

    Posted July 27, 2011: by Bill Sardi

    SAN DIMAS, CA (July 26, 2011) -Saying the newly proposed safety guidelines for dietary supplements would likely eliminate most children’s vitamins from store shelves, the first official comment regarding the FDA’s New Dietary Ingredient guidelines has been submitted, and it also calls for dietary supplements to be removed from oversight by the FDA altogether. The newly proposed guidelines were published on July 1 and are subject to a 90-day comment period.

    Bill Sardi, long-time dietary supplement advocate, health writer and dietary supplement formulator, speaking from his office in San Dimas, California, says dietary supplements are safer than tap water, table salt, aspirin and even food and it is unlikely the newly proposed guidelines will make them any safer. His 16-page critique of the FDA’s newly proposed safety tests, available for viewing at www.knowledgeofhealth.com ,demands that an economic impact report be commissioned before any further action is taken by FDA.

    Sardi says even if manufacturers of dietary supplements elected to comply with the new guidelines, the FDA itself couldn’t handle the volume of submissions. The FDA guidelines estimate there are 56,000 dietary supplements on store shelves. Any supplements formulated since 1994 would have to undergo safety testing. “That virtually represents all of the dietary supplements on store shelves today,” says Sardi.

    The guidelines in many instances would slow down innovation and ability to respond to newly published science, says Sardi, because it could take up to four years before a newly formulated supplement could reach the marketplace. Imagine if it were a life-saving supplement, just how impractical that would be, he said.

    The guidelines also require redundant testing. If ten companies that sell folic acid (vitamin B9) obtained from the same supplier, then ten separate safety studies have to be conducted, he says.

    Furthermore, the FDA’s guideline says synthetically-made supplements that are not obtained for dietary or botanical sources would be classified as drugs, not supplements. “All B vitamins are synthetically made, as are most brands of vitamin C, as well as coenzyme Q10, lipoic acid, vitamin D2, some brands of resveratrol and vitamin K2,” notes Sardi. Whether these dietary supplement will be removed from the marketplace and become drugs is unexplained by FDA says Sardi.

    Sardi says compliance with guidelines will likely cost dietary supplement industry, at a minimum, $4 billion, not counting expensive 1-3 year studies to prove supplements don’t cause birth defects, which would cost tens of billions more.

    Minimum toxicity tests would cost about $70,000 per item and probably another $1-2 million for animal studies to determine if a dietary supplement would be likely to produce birth defects.

    Most kids vitamin pills don’t generate sufficient profits to warrant the cost of testing, Sardi said. These products are already in the marketplace and no outbreak of birth defects or deaths have been noted, he emphasizes. “This is an expensive paperwork exercise” says Sardi.

    David Stouder, proprietor of Apple Health Foods in Redwood City, California, says facetiously that “we are going to have to shoot some customers in the store to come up with enough dead bodies to compare with deaths produced by FDA-approved drugs.” A false rationale for these onerous tests is that dietary supplements aren’t tested as thoroughly as prescription drugs. There have been no dietary supplement-associated deaths reported by the American Poison Control Center network in the past 8 years, says Stouder, who reviewed Sardi’s written comment before it was submitted to the FDA.

    Sardi says some factions within the dietary supplement industry are capitulating and planning to comply with the guidelines, but they haven’t carefully examined the costs. If the retail price of products rises because of this new guideline, you could end up with a lot of products dying on the store shelf due to lack of affordability, says Sardi. “The industry must fight the guideline over its impracticality and high costs,” he says. “Otherwise the dietary supplement industry may end up being a ‘dead man walking’.”

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