FDA warnings are issued weekly, sometimes almost daily, on a broad array of products that affect every American’s medication and food. It usually takes a good deal of evidence for an FDA Warning Letter to be issued and therefore people take these warning very seriously. It is a testament to FDA integrity that no one claims that there is any form of manipulation or politics involved. In fact, FDA critics sometimes complain that the FDA warnings should have been issued earlier.

This is why an FDA drug recall makes news. Fortunately, the FDA's process for approving drugs is exacting, even if it is expensive. All the scientific proof for safety and effectiveness necessary to get FDA approval is what helps reduce the frequency of FDA drug recalls.

If you're a firm trying to get a product through FDA approval, or have just gotten a product through the approval process and onto the market, nothing will cause you more difficulties than being notified about FDA publicly stating warnings about your new product.

Many companies that have FDA warnings issued for mislabeled contents are repackaging or re-selling products made in other parts of the world. Most frequently, the original manufacturer decided to cut corners on the product before selling it overseas, and the distributor was not informed of these changes. . Now the product needs to be relabeled to keep it in the marketplace. This is usually impractical and expensive, so the incorrectly labeled product ends up being recalled and destroyed. In many cases, the product can still be kept on the market so long as additional or corrected information is presented to the public.

But many times there is either a significant misprinting that was somehow not noticed by the company quality control staff until after it was shipped to stores. And sometimes the claims for the product are misleading or overstated. Either way, FDA warnings are usually very effective in stopping the sale and distribution of the product. This is because FDA authority is so pervasive that just a hint that FDA is prepared to take legal action is enough to force the company to agree with the position taken by FDA.

Product recalls occur one twentieth as frequent as mislabeling warnings. Product recalls require that the specific batches of product be taken off the market and are usually the result of additional findings related to the active ingredients, or the result of fraudulent claims about the safety or effectiveness of the product. A product recall is survivable by a small business but it requires proactive measures to 'get in front' of the regulatory agency and demonstrate that you're willing to do what it takes to make amends. (This is a marked contrast with many other parts of the world, where often times you don't find out about the problem with a product until the equivalent of a class action law suit is filed against the business.)

Product safety bulletins are like product recalls, only worse. These affect multiple batches and can result in taking the product off the market. These FDA warnings are basically calls to destroy the product completely, before it causes extreme harm. They are very rare; a recent product recall was for milk products from China tainted with melamine.


What To Do If You're The Subject Of An FDA Warning ?

The first thing to do is talk with the agency to assess which type of warning has been issued. The second is to decide whether it will cost more to fight the FDA on this issue or to comply - in most cases, even if the FDA is wrong, it's often less expensive for a company to comply. The time spent fighting the matter with FDA is very divisive and time consuming. Thus it is almost always better to organize business activity in order to comply with FDA in the first place. Meanwhile the company should fix the source of the problems cited by FDA immediately.

You can call Regulatory Affairs Associates at 248 855 5595 and we will determine the best approach to resolving your company’s particular problem and restoring good relations with FDA.