FDA Compliance in the Time of COVID-19. What's Next for Businesses?

We recently sat down with Lisa Capote, the Founder and President of Capote Law Firm to ask 5 questions about the effect of COVID 19 on FDA regulations, and other areas of business.

1. Tell us more about your company and how you got started. Capote Law Firm started in 2006. After working for a lawyer who practiced in the area of FDA Compliance, I decided to open my own firm and focus exclusively on FDA regulations. Since that time she has represented companies in the medical device, food, drug, supplement, cosmetic, children’s product industries. 

2. How have you adjusted your business to shelter in place and what effects do you think this global shift will have for small businesses? We were fortunate enough to go virtual over 4 years ago so we have not had to shift that much as a result of the pandemic, except for the lack of child care. We made this decision after analyzing how much time was spent in our offices versus time visiting clients at their locations. The reality is that most of our clients are not based in South Florida, where our offices previously existed, so there was no need for a physical location. I believe that virtual office space is the new normal. There are some businesses that will still require brick and mortar, but the reality is that retail has been suffering for years since the advent of online shopping and will continue to suffer. Small businesses only stand to gain from virtual offices, where possible. They can decrease overhead and pass the savings on to customers or enjoy their day and work less hours. 

3. What is the number one challenge that you foresee in the coming months for businesses in industries that require FDA compliance? The current FDA climate is in a status of flux. FDA is changing its guidelines on a daily basis. For companies that just got into the personal protective equipment industry the coming months will be an awakening for those that have not been doing compliance. Once FDA begins enforcement actions many of these new companies will be suffering. For companies that were in their respective businesses prior to the pandemic, I anticipate more paper inspections issued by FDA and when onsite inspections begin again those companies whose responses to paper inspections were inadequate will most likely be visited by an FDA inspector. 

4. How will changes in policy affect companies importing ingredients from abroad? I do not foresee any major changes for raw material, however for anyone in the personal protective equipment industry that is currently working under FDA’s Emergency Use Authorization I anticipate a complete shut down of the market once FDA removes the EUA for these types of medical devices and hand sanitizer. It will require companies new to market to either shift to FDA approved/cleared products or stop selling. 

5. What is one piece of advice or direction you would give to an entrepreneur in the early stages of starting a business during this time? I would recommend to stay nibble and be able to pivot quickly. Those companies that were able to leverage their contacts into a new industries quickly are the companies that have been selling products throughout the entire pandemic.

To learn more and connect with Lisa, visit www.capotelawfirm.com