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John N. Hathcock, PhD; Gloria J. Troendle, MD
Food and Drug Administration Washington, DC

JAMA. 1991;265(17):2190.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

In Reply.—

Dr Heimburger states that the summary report of Nature's Bounty's clinical studies indicates that the rise in serum cobalamin level after a single 400-µg intranasal dose approximates that from a 100-µg intramuscular dose. Dr Heimburger then suggests that the use of an intranasal gel would have a compliance advantage over daily oral cobalamin and would not entail the inconvenience or cost of intramuscular injections. He concludes that the use of Ener-B, with proper monitoring of cobalamin status, should be considered by physicians treating patients with pernicious anemia.

It is the Food and Drug Administration's (FDA) position that Ener-B Intra-Nasal Gel is a drug, a new drug, and is illegally marketed. The FDA has consistently regulated parenteral vitamin-mineral and topically administered nutritional products as drugs. On February 26, 1987, the FDA sent a regulatory letter to Nature's Bounty informing them that Ener-B was an unapproved new drug and was . . . [Full Text PDF of this Article]

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