Product Mislabeling Makes Recalls Likely

[Guest guest]

Free-Reprint Article Written by: Norm Howe

See Terms of Reprint Below.

*****************************************************************

*

* This email is being delivered directly to members of the group:

*

*

*

*****************************************************************

We have moved our TERMS OF REPRINT to the end of the article.

Be certain to read our TERMS OF REPRINT and honor our TERMS

OF REPRINT when you use this article. Thank you.

This article has been distributed by:

http://Article-Distribution.com

Helpful Link:

The Digital Millennium Copyright Act - Overview

http://www.gseis.ucla.edu/iclp/dmca1.htm

---------------------------------------------------------------------

Article Title:

==============

Product Mislabeling Makes Recalls Likely

Article Description:

====================

What happens when drug or medical device manufacturers mislabel

their products? The Food and Drug Administration (FDA) regularly

monitors labels for false claims and errors, often pulling whole

lots of product for which it finds a problem. Case in point: a

recent nationwide recall of Encore Tablets, a dietary supplement

sold in health food stores, via the internet and by mail order

nationwide and in Canada.

Additional Article Information:

===============================

612 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2008-01-07 11:00:00

Written By: Norm Howe

Copyright: 2008

Contact Email: mailto:info@...

For more free-reprint articles by Norm Howe, please visit:

http://www.thePhantomWriters.com/recent/author/norm-howe.html

=============================================

Special Notice For Publishers and Webmasters:

=============================================

If you use this article on your website or in your ezine,

We Want To Know About It. Use the following URL to let

us know where you have used this article, and we will

include a link to your website on thePhantomWriters.com:

http://thephantomwriters.com/notify.php?id=5608 & p=load

HTML Copy-and-Paste and TEXT Copy-and-Paste

Versions Of Article Are Available at:

http://thePhantomWriters.com/free_content/db/h/product-mislabeling.shtml#get_cod\

e

---------------------------------------------------------------------

Product Mislabeling Makes Recalls Likely

Copyright © 2008 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

The Food and Drug Administration (FDA) regularly monitors labels

for false claims and errors, often pulling whole lots of product

for which it finds a problem. Case in point: a recent nationwide

recall of Encore Tablets, a dietary supplement sold in health

food stores, via the internet and by mail order nationwide and in

Canada.

The product was recalled because it contains potentially harmful,

undeclared ingredients. According to FDA, the undeclared

chemicals poses a threat to consumers because they may interact

with nitrates found in some prescription drugs (such as

nitroglycerin) and may lower blood pressure to dangerous levels.

In a similar vein, approximately $2 Million of a potentially

harmful " cosmetic " eye product was recently seized by FDA. The

product, a batch of 12,682 applicator tubes of Age Intervention

Eyelash, may lead to decreased vision. Age Intervention Eyelash

is sold and distributed by Jan Marini Skin Research, Inc., of San

, Calif.

FDA considers Age Intervention Eyelash to be an unapproved and

misbranded drug because Jan Marini Skin Research has promoted the

product to increase eyelash growth. Before any new drug product

may be legally marketed, it must be shown to be safe and

effective, and approved by FDA.

FDA also considers the seized Age Intervention Eyelash to be an

adulterated cosmetic. The product contains bimatoprost, an active

ingredient in an FDA-approved drug to treat elevated intraocular

pressure (elevated pressure inside the eye).

Also in recent months, the labeling has been revised for the

diabetes drug Avandia. FDA announced that the manufacturer of

Avandia (rosiglitazone) has agreed to add new information about

potential increased risk for heart attacks to the existing boxed

warning. Avandia, which is used to treat type 2 diabetes, is

manufactured by GlaxoKline.

FDA is allowing Avandia to stay on the market while a new

long-term study to evaluate the potential cardiovascular risk of

Avandia, compared to an active control agent, is conducted by

GSK. The company agreed to add new information to the drug's

labeling, warning of the potential for increased risk of heart

attacks.

Mislabeling has also hit the dietary supplement industry, when

approximately $71,000 of dietary supplements was recently seized

at FDA's request. U.S. Marshals seized the goods from FulLife

Natural Options, Inc., of Boca Raton, Fla., which marketed and

distributed Charantea Ampalaya Capsules and Charantea Ampalaya

Tea.

Although these products were labeled as dietary supplements, they

were being promoted by FulLife for use in treating serious

conditions, such as diabetes, anemia, and hypertension. These

claims were evident in the products' labeling, including

promotional literature and FulLife's Internet Web site.

FDA considers these products to be unapproved new drugs because

they make claims related to the prevention or treatment of

diseases in the products' labeling.

Following an investigation of the firm's marketing practices,

FDA officials advised FulLife that the claims related to

prevention or treatment of diseases made these products subject

to regulation as drugs. Despite FDA's warnings, the firm failed

to bring its marketing into compliance with the law. During

subsequent inspections, FDA inspectors found that the offending

claims were still being made.

The seizure at FulLife is the second such enforcement action in

two months taken by FDA against dietary supplements being

promoted with drug claims to cure or treat diabetes and other

diseases or conditions.

They also seized an estimated $41,000 worth of inventory of

Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex,

MSM-1000, and Atri-E-400 capsules being promoted and distributed

by Charron Nutrition of Tallahassee, Fla., for use in treating

diabetes, arthritis, and other serious health conditions.

Whether products are cosmetic, medical or herbal, the best way to

avoid having product seized and losing money is to get labels and

marketing materials right the first time.

---------------------------------------------------------------------

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