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LOOKS. EXPERIENCE. THE WHOLE PACKAGE.
Hirschhorn + Young Graphics pursues the most technologically efficient
solutions to our client's packaging production needs. Together our
staff of over 20 full-time professionals with our proprietary
production and tracking system, provides project management, layout,
computer graphics, comping, regulatory graphics oversight, proofreading
and other necessary services to ensure your project is delivered on
time, accurately and with a commitment to quality.
Call us to find out how Hirschhorn + Young Graphics
can ensure your cosmetic or OTC packaging is regulatory compliant all
around the globe.
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REGULATORY NEWS |
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U.S. Labeling Requirements for Dietary Supplements and
Non-Prescription Drugs (OTC)
The U.S. Food and Drug Administration (FDA) has implemented new labeling requirements for all Dietary Supplement and Non-Prescription Drugs (OTC drugs). Its intent is to assist the industry in improving public adverse event reporting. This new requirement amends the FFD&C Act with respect to adverse event reporting for all Dietary Supplement and Non-Prescription Drugs. |
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In addition, the FDA recommends a prominent statement advising consumers that the domestic address or a domestic phone number is used to report serious adverse events.
These labeling requirements and recommendations are already in effect as of December 22, 2007. However, the FDA intends to begin enforcing this labeling requirement on or after January 1, 2009. Failure to bear a full domestic address or a domestic phone number will be considered "misbranded".
REGULATORY SPECS
Markets: United States ONLY
Products: Dietary Supplement (Vitamins, minerals, herbs, amino acids...) and Non-Prescription Drugs (OTC medications, cosmetic-drugs: sunscreens, acne, antiperspirant, antidandruff, skin protectants...)
Compliance Date: December 22, 2007
Enforcement Date: January 1, 2009
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The FDA requires all Dietary and Non-Prescription Drugs
(OTC drugs) to include the following labeling requirements as of December 22, 2007.
Domestic address-The product must bear a full U.S. mailing address, which includes the street address or P.O. box, city, state, and zip code.
OR
Domestic phone number-The product must bear a U.S. phone number, including area code.
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+ Copyright © Hirschhorn + Young Graphics. All rights reserved. +
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