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Nov 8, 2012

What Can You Expect From FDA Lawyers

If you manufacture, package, or distribute food, drugs, dietary supplements, medical devices, or cosmetics you will have to deal with the FDA, their many rules and regulations, and the many different types of forms that often have to be submitted. Because there is so much involved, most companies will choose to hire some lawyers to ensure that everything is taken care of.


Lawyers who specialize in FDA law can help you determine whether your product complies with the many different FDA and FTC regulations, and they can help you come up with an appropriate marketing strategy.

 

Registration


The FDA requires that all facilities that deal with foods, drugs, and medical devices are registered annually with the FDA. This includes any facility involved in manufacturing, processing, packaging, or storing the items. Additionally, manufacturers of drugs and medical devices must also list each individual product with the FDA every year.

Under the Bioterrorism Act, any drug or medical device manufacturer who uses importers has to file an importation statement that includes the registration numbers of all companies in the supply chain.

FDA Lawyers are qualified and experienced with all the necessary forms needed, and can help make this process run smoothly.

 

Dietary Supplements and Food


The FDA regulates all types of food and dietary supplements distributed anywhere in the United States. The FDA makes sure that they are safe, free of contamination, and that packages are correctly labeled. FDA lawyers will usually review ingredients and labels on all types of foods, including dietary supplements to ensure that they comply with the FDA regulations. FDA lawyers can help clients obtain FDA approval for any food additives that may be used; they can also ensure that all labels and packaging comply with FDA regulations. This can include health claims, nutritional content, and any other pertinent information. Dietary supplements are not allowed to have health claims on the packaging; however, they are allowed to have structure and function claims.

Your lawyers can help you understand what the difference is between a health claim and a function claim and help you to ensure that your packaging follows the strict rules laid out by the FDA.

 

Drugs


Pharmaceuticals and over the counter drugs are some of the most highly regulated products on the market. Whether you are manufacturing a prescription medication or an over the counter product there will be many different forms to fill out, and regulations to follow. You will also need to know what to do if something is recalled, or if you have to report an adverse event related to the drug. Rather than being buried by paperwork and trying to figure out which forms are needed for which product, hiring an experienced FDA lawyer will save you both time and money.

If your company deals with any types of foods, drugs, cosmetics, or medical devices, you will have to deal with the FDA at some point. There will be many different forms to fill out, packaging to get ready and an advertising campaign to plan. This is why it is an extremely good idea to hire some FDA Lawyers from some good company, whose experienced staff will be able to help you with every step of the process.

Trish Rounsaville is a freelance writer based in the U.S. who enjoys writing blogs about the legal system. She has a particular interest in the wide scope of the FDA and the need for many companies to find reputable FDA lawyers, Arrastia-Law

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