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USP standards recognized as hallmark of quality.

Vitamin and tonic dollar sales(*)

                                                    % dollar
                          Market   Dollar volume   change from
Product                    share    (millions)     prior year

Multivitamins              30.2%      $243.9          + 3%
Herbal supplements         11.9%        96.0          +37%
Vitamin E                  10.8%        86.9          - 1%
Vitamin C                   9.8%        79.4          + 6%
Calcium                     9.1%        73.7          + 8%
Vitamin B                   7.7%        62.1          + 9%
Children's vitamins         5.6%        45.2          - 1%
Iron                        4.7%        37.7             -
Vitamin A/beta-carotene     2.2%        17.3          - 8%
Vitamin packs               1.9%        15.1          +10%
All other vitamins          5.1%        41.4          +57%

* Dollar sales in drug stores for the year ended August 1995.
Source: Towne-Oller & Associates.
Vitamin and tonic unit sales(*)

                                                    % unit
                          Market   Unit volume   change from
Product                    share    (millions)    prior year

Multivitamins              26.5%      31.7              -
Vitamin C                  13.2%      15.9           - 1%
Calcium                    10.1%      12.2           + 6%
Herbal supplements         10.1%      12.1           +33%
Vitamin E                   9.4%      11.3           - 8%
Vitamin B                   8.9%      10.7           + 6%
Children's vitamins         6.28       7.5              -
Iron                        4.4%       5.3           + 4%
Vitamin A/beta-carotene     2.6%       3.1           -13%
Vitamin packs               1.2%       1.4           + 3%
All other vitamins          6.1%       7.4           +37%

* Unit sales in drug stores for the year ended August 1995.
Source: Towne-Oller & Associates.

WASHINGTON - The United States Pharmacopeial Convention Inc. (USP) standards for vitamin and mineral products, enforceable by the federal government, provide assurance that products claiming compliance meet rigorous standards of ingredient and finished product quality as well as standards that help ensure that people actually get the nutrients that they're paying for.

The USP, headquartered in Rockville, Md., is a nonprofit organization that's one of the oldest voluntary standard-setting groups in the country. Originally founded in 1820 to help ensure that pharmacists and doctors had a common understanding of the composition of prescription medications (the drags that pharmacists compounded from the doctors' directions), it has grown into the publisher of the federally enforced set of standards for the purity and potency of most drugs sold in this country, as well as for many of the inactive ingredients used to manufacture them.

In 1990 the USP undertook a three-part project involving vitamin and mineral supplements. First, it created 12 USP compositional standards for multiple vitamins, minerals and vitamin/mineral combinations. Second, it established test methods that are important in judging product quality, including tests for disintegration and dissolution. Third, the USP information division began exploring the varied uses of nutritional supplements.

Being sensitive to industry and consumer concerns that nutritional supplements not be viewed as drugs, the USP recently created a section in its publication dedicated just to multi-ingredient nutritional supplement standards and related test methods. However, single nutrients are covered by the USP drug monographs and by Food Chemicals Codex food ingredient monographs.

USP standards are recognized around the world as being the hallmark of product quality. If a product claims to comply fully with the USP, that means the nutritional ingredients meet USP standards for strength, purity and quality; the supplement contains the amounts of those ingredients claimed, within strict limits; the supplement contains appropriate formulation ingredients; the supplement meets tests that help ensure that nutrients will actually end up inside the body rather than pass right through; and the supplement has been manufactured in conformity with strict good manufacturing practices, including microbial limits.

But not every reference to the USP on a supplement label means the same thing. In some cases, the claim is that the product disintegrates or dissolves within the time allotted by the USP. If consumers want greater USP coverage, it will be necessary to find a product that uses the USP designation as part of the name on the label, e.g. "multivitamin and iron soft gets - USP." That way, consumers will know that the product meets all USP criteria.

Two aspects of the Food, Drug and Cosmetic Act provide assurance that products claiming to meet some or all USP criteria in fact comply with those standards. First, the act prohibits false claims for nutritional supplements in both their labeling and advertising. So the Food and Drug Administration (FDA) can use any claim of USP compliance on the label, in store displays or in magazine ads as a basis for checking the product to see if the claim is truthful. False or misleading claims, including claims that imply greater compliance than is the case, can lead to product seizures or recalls.

Even more directly, the new Dietary Supplement Health and Education Act amendments to the Food, Drug and Cosmetic Act, passed in October 1994, provide that any dietary supplement that is covered by the specifications of an official compendium and claims to meet those specifications but fails to do so is misbranded and thus subject to regulatory action by the FDA.

While the term "official compendium" isn't defined, the USP has historically been the premier official compendium in the United States. This publication is totally revised every five years with interim revisions and announcements. In order not to compete with the Super Bowl, the USP, in its current edition USP 23/NF 18, switched from Roman to Arabic numerals. Its information service, USP DI (originally USP Dispensing Information) is reissued annually, with ongoing revisions and usage information both for practitioners and consumers.

USP drug standards were first recognized as official in the Food and Drug Act of 1906. The 1938 Food, Drug and Cosmetic Act, which is still in force, renders a drug adulterated if its name is recognized in the USP and it fails to comply with USP standards.

Few important drugs aren't included in the USP, and because mandatory coverage is triggered by the generic name of the drug, all aspirin is USP, even if the bottle doesn't say so. In addition, the USP DI gives doctors, pharmacists and consumers information about how to use drugs, including directions for well-recognized uses that don't appear on the drug's labeling.

Now dietary supplements have official compendium standards that are enforced by the FDA. But consumers have to look carefully at the USP claims on labels to be sure that they are getting an all-USP product.

Eugene Lambert is a partner in the Washington law firm of Covington & Burling who has worked closely with the FDA in crafting numerous pieces of legislation pertaining to dietary supplements.
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Title Annotation:United States Pharmacopeial Convention
Author:Lambert, Eugene
Publication:Chain Drug Review
Date:Oct 9, 1995
Previous Article:Drug chains face test in the vitamin market.
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