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What are FDA Warning Letters?

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If a company or individual violates FDA rules, the administration attempts to work with that company or individual before resorting to measures that are more drastic. FDA warning letters are an attempt by the FDA to spur a manufacturer or distributor of food, cosmetics, medical devices or nutritional supplement products into taking voluntary corrective action.

An FDA Warning Letter Example
Recently, the FDA has stepped up its enforcement of the rules and regulations that govern the advertising claims made regarding nutritional supplements. Nutritional supplements that are promoted as being able to cure, prevent or mitigate disease are being treated as new drugs by the FDA.

Under FDA rules, new drugs must undergo a lengthy and expensive vetting process before they can be legally sold in the United States. Therefore, a nutritional supplement manufacturer who makes false drug promotional claims that his or her products can effectively treat disease may receive a warning letter from the FDA.

In the letter, the administration will cite several examples of the claims that triggered the warning. After laying out the situation, the warning letter will name the sections of Untied States Code that apply, and give the recipient of the letter a short time to notify the administration of the actions being taken to bring products in compliance with the code.

An FDA warning letter closes with a reminder that enforcement action can be taken against the manufacturer, often without any further notice. FDA warning letters do not give the recipient advice or suggestions on how to correct the issues that triggered the warning.

Are FDA Warning Letters Public?
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Yes. Under the Freedom of Information Act, FDA warning letters are posted online at the FDA website. Manufacturers are allowed to make responses to these records, which may be visible to the public at the FDA’s discretion.

Warning letters are maintained in a searchable database. The FDA cautions that the letters contained in the database may not reflect any subsequent changes made to the products, goods, misleading or deceptive product labels or other issues that prompted the FDA warning letter. Interested consumers can also request FDA records not normally prepared for public distribution.