Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers

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Article Title:

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Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers

Article Description:

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How do small Dietary Supplement manufacturers comply with the new

Dietary Supplement GMPs? The U.S. Food and Drug Administration

(FDA) announced plans to publish a compliance guide that will

provide assistance to small dietary supplement manufacturers.

Additional Article Information:

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440 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2009-01-05 11:00:00

Written By: Norm Howe

Copyright: 2009

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Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers

Copyright © 2009 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

The U.S. Food and Drug Administration (FDA) announced plans to

publish a compliance guide that will provide assistance to small

dietary supplement manufacturers who are trying to implement good

manufacturing practices (cGMP) legislation.

In 2007, the final rule of the GMP legislation was passed, which

provided standards specific to supplements for purity, safety and

legality in manufacturing. In June 2008, big companies (over 500

employees) were required to implement these new standards.

Mid-sized firms must implement the new standards by no later than

June 2009, and small firms (less than 20 employees) have until

June 2010.

The director of the FDA?s Division of Dietary Supplements

Programs, Dr. Vasilios os, recently stated that guidelines

are in the works, including the aforementioned Small Entity

Compliance Guide.

The FDA defines a dietary supplement as ?a product taken by mouth

that contains a dietary ingredient intended to supplement or

enhance the diet.? Dietary ingredients may include vitamins,

minerals, herbs or other botanicals, amino acids, and substances

such as enzymes, organ tissues, glandulars, and metabolites. In

addition, dietary supplements can be extracts or concentrates,

and may also be found in forms such as tablets, capsules, soft

gels, gel caps, liquids, or powders.

In October 1994, the Dietary Supplement Health and Education Act

(DSHEA) was signed into law by President Clinton. DSHEA places

dietary supplements in a special category under the general

umbrella of " foods, " thus FDA's Center for Food Safety and

Applied Nutrition is responsible for the agency's oversight of

these products and requires that every supplement be labeled a

dietary supplement. Before DSHEA, dietary supplements were

subject to the same regulatory requirements as were other foods.

DSHEA stipulates that the dietary supplement manufacturer is

responsible for ensuring that a dietary supplement is safe before

it is marketed. The FDA is responsible for taking action against

any unsafe dietary supplement product after it reaches the

market, including monitoring safety, e.g. voluntary dietary

supplement adverse event reporting, and product information, such

as labeling, claims, package inserts, and accompanying

literature. (The Federal Trade Commission regulates dietary

supplement advertising.)

While manufacturers are not required to register their dietary

supplement products with the FDA before producing or selling

them, each manufacturer is responsible for registering its

production facility with FDA and for establishing its own

manufacturing practice guidelines to ensure that the dietary

supplements it produces are safe and contain the ingredients

listed on the label.

For those manufacturers that require guidance either before the

Small Entity Compliance Guide is released, or after (in

interpreting the guide), it?s best to turn to a professional that

understands what it takes to get a supplement to market and keep

it there.

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Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com