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The Consequence of Breaching FDA Regulations.

I’m David Holub, an attorney focusing on personal injury law in northwest Indiana.

Welcome to Personal Injury Primer, where we break down the law into simple terms, provide legal tips, and discuss personal injury law topics.

Today’s question comes from a caller who got a recall notice on a product they were using. The notice said that the FDA encouraged the recall, but stressed that it was voluntary. The caller wanted to know her legal rights.

Whether the product is a can of green beans that has been recalled, or peanut butter, or sanitary wipes, or contaminated baby formula, a good source of information about what prompted the recall can be obtained by doing a Freedom of Information Act request to the FDA.

The Food and Drug Administration is often criticized in the news for either not doing its job to protect the food and drug supply from contaminants, or being too aggressive in doing its job, or you name it, they’ve probably been accused of it.

But, let’s not discuss how the FDA does its job. That could be an hour long podcast.

Instead, I want to discuss why the FDA is a good source of information if there has been a product recall.

For the most part the FDA requires different businesses which process food and drug products to police themselves.

This means that the processing companies must periodically do inspections of their own products for potential contamination, and they must send those inspection results to the FDA.

In other words, the FDA doesn’t typically go out to a company’s facility and do an inspection, although it may randomly do that, rather, it takes action if the expected testing results aren’t filed on time, or when those testing results show a red flag that the product is not sanitary or pure.

Consequently, if a lawsuit needs to be filed, a first step would be to do a Freedom of Information Act request to the FDA seeking all of the testing data received on the suspected contaminated product in the last couple of years. This can provide great information to support a lawsuit.

There is a cost to obtaining this data, and the FDA may redact certain information from the reports, based on a desire to protect confidential trade secret information, but the information that a litigant can obtain through the FDA can be extremely valuable.

I hope you found this information helpful. If you are a victim of someone’s carelessness, substandard medical care, a product defect, work injury, or another personal injury, please call (219) 736-9700 with your questions. You can also learn more about us by visiting our website at DavidHolubLaw.com – while there, make sure you request a copy of our book “Fighting for Truth.”