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FDA Approval

The FDA, or the U.S. Food and Drug Association, is a federal agency that monitors the trading and controls the safety standards for the food and drug industries in the United States. When any company or business wants to get any sort of product approved that falls into the food or drug category, they would have to go through the FDA to get approval to sell that product to the public.

How does one get FDA approval for an imported food that they would like to sell to the public?

When one imports a food into the U.S. they are able to do so without getting approval from the FDA first. As long as the business that is going to be selling that product has been FDA approved and notifies the FDA about new products and said import, the person importing the product would not need to go through the process of applying for approval from the FDA.

How does one get approval from the FDA for a product that originated from approved meat markets and is going to be sold as dog treats?

The FDA does not normally require approval of food that is meant to be sold for dogs to eat. They would most especially not require approval if the meat originated from an already approved meat market. The FFDCA, the Federal Food, Drug, and Cosmetic Act, would control the approval of this product, and they require that all animal foods be safe to eat. They also require that they are produced in sanitary conditions and be truthfully labeled before selling them.

How would one get approval for a product that would have contact with the mouth but has been approved for food contact?

In order to get approval for the product to be placed in the mouth, one would need to fill out an application for approval and submit it to the FDA. Depending on the type of approval the person is looking to receive from the FDA, they would have to provide scientific evidence and studies that prove that the product is safe to be placed in the mouth. The fact that the product has been approved for food contact would also need to be stated in the application so the FDA is aware of that fact when making the decision of whether to approve the product or not.

Can one sell a product without FDA approval as long as they state on the label that the product has not been FDA approved?

There are fairly specific labeling requirements made by the FDA depending on what ingredients are in the product. Here are two links that will specify how to label depending on what is in the product: http://www.fda.gov/food/dietarysupplements/dietarysupplementlabeling/default.htm and also http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm. If these links do not specify for any product, contacting the FDA is also a wise choice. When labeling and selling a product that has not been approved by the FDA it is very important to be careful how the product is labeled. If it is labeled incorrectly or untruthfully in any way, the FDA would consider that a false claim and the person trying to sell the product could be held liable and possibly get into some sort of trouble with the FDA.

If one wanted to sell a product and label it as ‘personal lubricant’, would they need the FDA’s approval to label it as such and sell the product?

The FDA would not need to approve this product if it is labeled as a ‘personal lubricant’. Products that are labeled as such do not go through an approval process with the FDA. The only way a product like personal lubricant would need to be FDA approved would be if it was used for a medical reason or was labeled as medication.

There are a good number of products that one might want to sell that would have to be approved by the FDA before the product can be sold. However, there are also a few situations where approval from the FDA would not be needed. If one is planning on selling a product, it is advisable to make sure that the product does not need to be approved by the FDA just to be on the safe side. Trying to sell a product that needs FDA approval can have very serious consequences. Whenever questions arise and one is unsure, it is best to consult the Experts.
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