Food and Beverage
Ensure your innovative products stand out from the competition — while meeting FDA regulations
Competition in the food and beverage industry is fierce. Consumers are increasingly concerned about the quality of food and drinks they consume. On top of that, you have a plethora of complex regulations to navigate.
In order to compete, food and beverage businesses need to have thorough regulatory compliance programs — and value-added products that consumers gravitate to.
Establish and maintain your position in the market with an FDA specialist that knows the ins and outs of the regulations you need to follow. Not only that, we can provide you with guidance on how to balance marketability and compliance — using the right language on your packaging and marketing materials.
Here’s how FDA Atty helps finished food, food ingredient, and food contact material companies like yours:
Label review: Not only does the FDA have rules around the kind of information to include on labels, such as statement of identity, net quantity of content, and ingredients, they also have to be formatted a specific way. We ensure your health claims and nutrient content claims meet the content requirements, and are in the correct format.
Advertising review: There are specific regulations around what you can say in third-party testimonials, websites, social media, and more. We help ensure your marketing content meets FDA and Federal Trade Commission (FTC) regulations.
GRAS: Consumers and large retailers want to know if your ingredients are Generally Recognized As Safe (GRAS). FDA Atty can complete an ingredient review, help you self-affirm GRAS, or file a GRAS notice with the FDA.
Adverse event reporting and record keeping: You must report any adverse events that are associated with your product to the FDA. We help you develop standard operating procedures that assist in identifying and reporting these events, training staff, and conducting audits.
Export certificates: Do you need an Export Certificate to Foreign Governments or Certificate of Exportability? We resolve the confusion so you understand the process, and know what steps to take.
Import alerts: Has your product been detained by the FDA at customs? You need to take action right away — otherwise your product may be destroyed and your company listed on an import alert, which are publicly published notices of violation. We help you avoid getting on an import alert. If you’ve already received one, we can petition the FDA for your removal.
Warning Letter and border detention assistance: Have you received a Warning Letter from the FDA or have your products been detained at the border? You may not need to destroy your products, if you can ask the FDA to resolve the issue. Time is of the essence, so contact us to start the process right away.
Are you ready to grow your market share while staying in compliance with the FDA?
How We Help
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.
Physician- Entrepreneur- Consultant
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.