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Do I Really Need FDA Approval?

Although this may seem like an obvious answer, there are many companies that feel FDA compliance is cost prohibitive, and try to find workarounds, and end up in situations like this.


Getting FDA approval for a product can be a long and arduous process. Time and cost can be prohibitive, depending on your sector of the food and beverage industry. It’s not unusual, for example, for a pharmaceutical company to spend $125 million and ten years working to get a new drug approved. Other industries have an easier time getting approval; a new beauty product may need only $1,000 and one year to get approval, and dietary supplements have less strict regulations as well.

Below are some common questions businesses have about FDA regulations:

Does My Product Even Need FDA Approval?

Ask yourself: “Is my product a food, beverage, drug, medical device, tobacco product, cosmetic, vaccine, or animal/veterinary product? Will it be given to or used by humans or animals?”


If you answer yes to any of those questions, your product requires approval.

What Happens if I Ignore the Regulations?

Failure to comply with FDA regulations leads to serious consequences. These are government laws and punishable as such. Punishments include severe fines and, if someone gets sick or dies because of your product, you’re likely to have a lawsuit on your hands – and if you lose, you could face criminal charges.

Minimize Risks to FDA Compliance Issues eBook

How Will Approval Help My Business?

People trust products with FDA approval, so you’re likely to get more sales if customers know that your products have been tested and are safe. It is impossible to break into large markets without FDA approval.

In addition, if you have a product that is supposed to be approved but isn’t, many stores won’t even carry it. Therefore, for your product to become available in stores, you will need to meet the regulations.


Are you a company in the food and beverage industry that’s struggling to meet FDA guidelines for your products? Southeast Computers can incorporate the process of getting FDA approval right into your existing ERP system. Contact us for more information.


About Southeast Computer Solutions


Southeast Computer Solutions is based in Miami, Florida, and has additional operations in Mexico. For over 30 years, we have positively impacted the success of small and mid-sized businesses with effective business management implementations that improve our clients’ operations. We listen, we are accessible, and we care. Learn more by visiting our website or calling 305-556-4697.


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