How Small Businesses Can Work Toward FDA Compliance

Updated: Dec 20, 2019

Starting your own small business can be hard work, but extremely rewarding. Add a major governmental agency like the FDA into the mix and pure fright can begin to set in. Understanding the piles of regulations and requirements that come along with starting a business can be complex, time-consuming and downright scary.


Entrepreneurs Beware

Entrepreneurs have the most fun, right? They are able to create the things they can see in their minds. The truth is that when you are only limited to what you know, the things you don’t may harm you. Take the regulation of most of the products on shelves today. The Food and Drug Administration regulates, not just food and drugs, but cosmetics, medical devices, tobacco, biologics, veterinary and dietary supplements. Many entrepreneurs in these areas are creating breakthrough products, but there is a whole other side to creating a product that they may not anticipate.


In such a fast paced world, many small businesses begin with an idea and go straight to market without thinking twice. This is until the dreaded FDA warning letter arrives. Many small businesses must be wary of the FDA regulations affecting their industries before they take a swan dive into the unknown.


Be Proactive


Most small businesses don’t want to shell out the extra cash or time it may take to be sure they are compliant from the get go. However, there is a very high chance they will run into issues if they fail to be proactive. Business owners should make sure to look at the regulations affecting their product well ahead of any launch. Ultimately, this will save time and cash – which we all could use more of.


Read, Read and Read Some More


The most important step to take before wandering into a new industry is to research any compliance issues in advance. In the case of industries regulated by the FDA, a quick read over the FDA’s website can give you a base knowledge of what you need to get started. The FDA has even graciously provided small businesses with a guide to help with the basics.


Hire An Expert


Once you have a base knowledge, you are on your way. The next step is to ensure that you are right about what you have read and you aren’t missing anything important. One way you can inadvertently miss something is if a new regulation passes while you are in the process of getting your business started. This can happen to business owners who aren’t keeping track of the constantly changing regulatory landscape. Hiring an FDA attorney or consultant to review what you have and keep you up-to-date on the regulations coming out could mean the difference between a major lawsuit on your hands and a clean slate.


Stay Updated


That leads well into the final step which is to stay updated on the latest news affecting you industry. Sign up for industry updates or hire someone for a small fee to keep track of it for you. Either way, the industries of today are in a constant state of flux as are the regulations. It would be wise to make sure you don’t fall out of compliance from a lack of due diligence.


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