--- title: Do I Really Need FDA Approval? description: Questioning whether or not you need FDA approval on your items? This blog post will give you the insight you need to stay inforned. image: https://blog.southeastcomputers.com/hubfs/Images/FDA%20approved%20stamp.jpg --- **[Sage X3](https://www.southeastcomputers.com/sage-enterprise-management-infomation) | **[Sage 100cloud](https://www.southeastcomputers.com/sage-100cloud-information) | [Acumatica](https://www.southeastcomputers.com/acumatica-information) | [LATAM Fiscal Requirements](https://www.southeastcomputers.com/latam-fiscal-requirements-localize-sagex3-sage-500) | [Contact Us |](https://interact.southeastcomputers.com/contact-us) [ 888-773-2161](tel:888-773-2161)**** [![logo-naw-southeast-website](https://blog.southeastcomputers.com/hs-fs/hubfs/logo-naw-southeast-website.png?width=578&height=160&name=logo-naw-southeast-website.png "logo-naw-southeast-website")](https://www.southeastcomputers.com) This is a search field with an auto-suggest feature attached. - There are no suggestions because the search field is empty. ![Florida Miami Image](https://blog.southeastcomputers.com/hs-fs/hubfs/Banners/Florida-Miami.jpg?width=2880&name=Florida-Miami.jpg "Florida Miami Image") # Blog Want our new blog posts delivered right to your inbox?  July 16, 2015 # Do I Really Need FDA Approval? - [Tweet](https://twitter.com/share) ![authorIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/authorIcon.png) By [Jaleidy Tannenbaum](https://blog.southeastcomputers.com/author/jaleidy-tannenbaum) ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [Food and Beverage](https://blog.southeastcomputers.com/topic/food-and-beverage), [All](https://blog.southeastcomputers.com/topic/all) [![Do I Really Need FDA Approval?](https://blog.southeastcomputers.com/hubfs/Images/FDA%20approved%20stamp.jpg) ](https://blog.southeastcomputers.com/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](http://www.forbes.com/sites/alexmorrell/2015/03/12/lawsuits-say-protein-powders-lack-protein-ripping-off-athletes/).   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](https://blog.southeastcomputers.com/dietary-supplements-and-the-fda) 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](https://blog.southeastcomputers.com/avoid-125000-fines-by-complying-with-the-fda-haccp) and, if someone [gets sick or dies because of your product](https://blog.southeastcomputers.com/why-we-need-the-fdas-food-and-beverage-regulations), 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](https://no-cache.hubspot.com/cta/default/418036/1c6a9316-6f2e-42c7-80be-d8062d7f83f5.png)](https://cta-redirect.hubspot.com/cta/redirect/418036/1c6a9316-6f2e-42c7-80be-d8062d7f83f5) ## 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](https://www.southeastcomputers.com/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. 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[NEXT POST **](https://blog.southeastcomputers.com/use-design-for-assembly-guidelines-for-cost-effective-production) ### Related posts [Read More](https://blog.southeastcomputers.com/10-ways-sage-x3-keeps-you-in-compliance-with-the-fda) ### [10 Ways Sage X3 Keeps You in Compliance with the FDA](https://blog.southeastcomputers.com/10-ways-sage-x3-keeps-you-in-compliance-with-the-fda) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) July 30, 2016 Part of the FDA’s [Food Safety Modernization Act (FSMA)](https://blog.southeastcomputers.com/what-you-need-to-know-about-the-food-safety-modernization-act) is meant to help prevent wide-scale public health issues by requiring companies.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [Food and Beverage](https://blog.southeastcomputers.com/topic/food-and-beverage) [Read More](https://blog.southeastcomputers.com/3-strategies-to-ensure-supply-chain-quality) ### [3 Strategies to Ensure Supply Chain Quality](https://blog.southeastcomputers.com/3-strategies-to-ensure-supply-chain-quality) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) July 21, 2016 As we mentioned in last week’s blog, [How Business Management Software Aids Food & Beverage Industry Compliance](https://blog.southeastcomputers.com/food-and-beverage-business-management-software-solutions), product recalls can cost.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [Food and Beverage](https://blog.southeastcomputers.com/topic/food-and-beverage) ### Search  --- ### Recent Posts ### Posts by Topic - 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