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FDA Enforcement Continues to Rise

Posted by hrs.jmorgan on May 28, 2013 at 3:25 PM

While news reports discuss the diminishing funds for many government programs, it seems that the FDA remains unaffected.  In fact, FDA Warning Letters continue to rise in number, indicating that the need for compliance to the regulations is more important than ever.  While it may be human nature to take on a "Big Brother is out to get us" attitude, the facts remain that the recipients of these enforcement actions have simply had deficiencies in their Quality Systems.

The ripple effects have extended to web sites that make health claims for products that have not been properly managed in today's regulatory environment. And it is important to note that the FDA need not send an investigator to the place of business.  A few key taps can begin a web review that can effectively shut down a burgeoning web business.

Another area that previously flew under the radar is the neutriceutical or dietary supplement industry, where regulations are similar to that of medical device and pharmaceutical companies.  However, unliike the device and pharma regulations, those for dietary supplements are shown in a  reader-friendly Q and A format in addition to the stiffly-penned regulations. (see  As a result of increased scrutiny, Warning Letters to dietary supplement manufacturers have steadily increased over the past three to five years.

In the FDA's own words:

A Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.

Worse actions can wait in the wings, including recall, seizure, injunction, administrative detention, civil money penalties,and/or prosecution to achieve correction.

It is therefore more important than ever that manufacturers understand the requirements for legally providing medical devices and dietary supplements and make the correct enhancements and corrections to their Quality Management Systems to avoid the potentially inevitable Warning Letter.

Hawai'i Regulatory Services can perform a regulatory Gap Analysis or Web Site Regulatory Review.  Please use the Contact Us form in this website.  Hawai'i Regulatory Services can help.

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