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Amrion magnesium, boron osteoporosis claims unapproved health, drug claims -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

AMRION MAGNESIUM, BORON OSTEOPOROSIS CLAIMS ARE DRUG CLAIMS, FDA tells the company in a Dec. 1 "courtesy letter" recently made available by the agency. Amrion had filed structure/function claims regarding a link between various substances and osteoporosis for its HealthSmart Daily Essentials, HealthSmart Calcium Carbonate and HealthSmart Calcium & Magnesium Complex. "These statements are not statements of nutritional support subject to section 403(r)(6) of the [Food, Drug & Cosmetic Act], but are health claims subject" to another section of the act, FDA stated. Supplement manufacturers are only permitted to make health claims for calcium and osteoporosis. Amrion plans to make all of the modifications requested by FDA.
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