How To Avoid the Consequences of FDA Regulations on Your Startup


The FDA began regulating around the time they began to notice that the food and drugs that can sustain us can also be just as dangerous. The Federal Food, Drug and Cosmetic Act was passed by Congress in 1938 after an Elixir of Sulfanilamide killed 107 people in 1937. This was the first in a long line of FDA regulations. Since then, the FDA has been the driving force in ensuring the safety of our nation by regulating much of what we consume and use. But have they also become too cumbersome to the growth of startups?

Ah, the startup company. It’s trendy, edgy and mostly used to refer to the technology industry. However, there are plenty of startups in food, cosmetic, dietary supplement and even the electronic cigarette industry that are making their way up the ladder – and many are blending their industries with technology to create hybrids.

Beginning a startup can be exhilarating and exciting. It can also be a far fall off a steep cliff. When entrepreneurs are thinking of beginning their startup companies, they are focused on making an amazing product that will sell amazingly well. Until …. they receive the dreaded FDA inspection and then warning letter. This letter will outline the few things that they didn’t think of when starting their company. Whether it’s the fact that they placed a “reduces wrinkle”-esque statement on their anti-aging crème bottles or that they forgot to list all of the ingredients on their food labels, this can add more stress than is necessary to an already stressful process. The FDA is out there with a mission of keeping consumers safe, but could it also be limiting what is available to the consumers as well? Regulations can be both harmful and helpful to industry. It is important for companies and in particular startups to be weary of steps to ensure that you are not left in the dark when the warning letter arrives. Here are a few guiding points to help avoid more headaches during the early part of your startup journey:

1 – Start Your Research Early

When starting a company, most of the focus is on the product, the ideas and probably the money. However, a regulatory snafu can set you back even more than the product not selling as well as it should. Make sure to start researching some basic compliance requirements as you get started so you don’t make a mistake too big to fix.

2 – Review Other Products Similar to Yours

It may seem obvious to get to know what your competitors are doing when launching your product, but the idea is not just to look at how they have designed their product, but also their components that are most likely regulated. This could include the labeling, ingredients, packaging and marketing materials. Review the FDA regulations that apply to labeling to get a better idea of what is required.

3 – Hire an FDA Attorney or Consultant

Attorneys can be expensive and hiring one can be difficult to even fathom when you are trying to get your company off the ground. However, an attorney with knowledge of your industry and the regulatory landscape can assist you in ways you will be thankful for later. There are attorneys who charge flat fees or work with you on billing. It is vital that you start this relationship early to make sure you are doing things right before you receive a notice of non-compliance.

4 – Have Someone on Staff Who Can Assist with Compliance and FDA Regulations

When you begin, it may make sense to begin learning the regulations yourself to at least have a basic understanding of what is required. Eventually though, you will need to have someone on staff that understands and focuses on the developments in regulations that can affect your business. This can be in the form of an employee whose job is to focus on regulations, or it can be an attorney or independent consultant that you pay a lower monthly fee to keep updated on anything new that comes up. With someone constantly abreast of the changes, you will be less likely to experience any major regulatory issues that could be very harmful to your company and yourself personally.

5 – Update Often

Keeping your marketing, labeling and products up to date are essential to avoiding any negative regulatory attention. Make sure that whomever you have chosen to ensure your compliance is constantly watching out for new regulations that affect your industry. New regulations, like the recent electronic cigarette regulations that have greatly affected the industry, could severely affect your bottom-line.

There is no completely sure-fire way to avoid every possible tripping hazard when starting a new company and honestly, those trips can usually lead to more success in the end. Nevertheless, ensuring that you are knowledgeable about the regulations that affect your industry, and your product can be an avoidable one.

If you would like assistance with FDA compliance for your food, drug, medical device, cosmetic or tobacco product, please contact our firm and reach an FDA lawyer who can assist. An FDA attorney can help you bring your product to market in full compliance.