New Dietary Supplement Regulations: What You Need to Know

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Article Title:

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New Dietary Supplement Regulations: What You Need to Know

Article Description:

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Does your company make Dietary Supplements? The Food and Drug

Administration has published new Current Good Manufacturing

Practices (CGMPs) regulations for dietary supplements. These

regulations will affect any manufacturers of dietary supplements

who sell product in the United States. Here are some highlights

of the new regulations.

Additional Article Information:

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606 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2008-03-13 11:12:00

Written By: Norm Howe

Copyright: 2008

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New Dietary Supplement Regulations: What You Need to Know

Copyright © 2008 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

The Food and Drug Administration has published new Current Good

Manufacturing Practices (CGMPs) regulations for dietary

supplements. These regulations will affect any manufacturers of

dietary supplements who sell product in the United States.

The final CGMPs are effective in June 2008 for large companies,

but companies with less than 500 employees have until June 2009,

and companies with fewer than 20 employees have until June 2010

to comply with the regulations.

According to the new regulations, manufacturers must establish

and use master manufacturing and batch production records;

establish procedures for quality control operations; and keep a

written record of each product complaint related to CGMPs.

Under the CGMP rule, manufacturers are also required:

* to employ qualified employees and supervisors;

* design and construct their physical plant in a manner to

protect dietary ingredients and dietary supplements from becoming

adulterated during manufacturing, packaging, labeling and

holding;

* use equipment and utensils that are of appropriate design,

construction, and workmanship for the intended use;

* establish and use master manufacturing and batch production

records;

* establish procedures for quality control operations;

* hold and distribute dietary supplements and materials used to

manufacture dietary supplements under appropriate conditions of

temperature, humidity, light, and sanitation so that the quality

of the dietary supplement is not affected;

* keep a written record of each product complaint related to

CGMPs;

* and retain records for one year past the shelf life date, if

shelf life dating is used, or two years beyond the date of

distribution of the last batch of dietary supplements associated

with those records.

Probably the biggest change is the requirement to have written

procedures for all the quality critical processes in their

manufacturing operations. Also of interest is what FDA did NOT

do. They did not require the Dietary Supplement makers to

validate their manufacturing processes. FDA did, however, require

that Dietary Supplement manufacturers use scientifically valid

analytical methods to test their final products.

The Dietary Supplement Health and Education Act (DSHEA) has been

in existence since 1994. Under DSHEA, manufacturers have a

responsibility to substantiate the safety of their products and

determine that any representations or claims made about their

products are substantiated by adequate evidence to show that they

are not false or misleading.

The new, final CGMPs will help to ensure manufacturers produce

unadulterated and properly labeled dietary supplements in order

to protect consumers. Consumers will in turn have access to

dietary supplements that meet quality standards and that are free

from contamination and are accurately labeled, which will give

consumers greater confidence that the dietary supplement they use

has been manufactured to ensure its identity, purity, strength,

and composition.

Examples of product quality problems that the rule will help

prevent are: dietary supplements that contain ingredients in

amounts that are greater than those listed on the label; dietary

supplements that contain ingredients in amounts that are less

than those listed on the label; wrong ingredients; other

contaminant (e.g., bacteria, pesticide, glass, lead); foreign

material in a dietary supplement container; improper packaging;

and mislabeling.

The interim final rule does allow manufacturers to petition FDA

for an exemption from the requirement of 100 percent identity

testing of one or more dietary ingredients used in manufacturing

the dietary supplement. The manufacturer would provide data to

demonstrate that its proposed reduced frequency of identity

testing does not materially diminish assurance that the dietary

ingredient is the correct dietary ingredient. Each petition will

be considered on a case by case basis.

The new CGMPs are key in bolstering consumer confidence regarding

dietary supplements, an industry that at times has been looked at

unfavorably in recent years. For more information on the new CGMP

regulations, go here: http://www.cfsan.fda.gov/~dms/dscgmps6.html

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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