Meet FDA requirements while gaining market share with your animal food and drug products
Many people assume that the FDA applies the same human product categories to animal products as well. The truth is, that’s not the case. The FDA has only two categories for animal products: food and drug. This applies to both pets and animals for human consumption.
As a result, you have to be very careful how you label and market your animal products so they fall into the correct categories.
With extensive experience working within the FDA landscape, we can help your animal product business with all aspects of regulation, manufacturing, approval, and marketing. From medicated feed mill licenses to approval of drugs for aquaculture, we’re here to help. Our services include:
Label review: Did you know that the FDA regulates what content goes on your product labels, in addition to how it’s formatted? We ensure your label content includes the necessary health and nutrient content claims and is presented in the right way.
Advertising review: The claims you make about your animal products on your website, social media, point-of-sale materials, and other marketing channels is regulated both by the FDA and the FTC. We review all your marketing content so it meets the regulatory guidelines.
Export certificates: Having trouble figuring out exactly which forms you need to fill out in order to export your animal food and drug products? We take care of the export forms for you so you can focus on running your business.
Warning Letter and border detention assistance: Did you receive a Warning Letter from the FDA or are your animal products held up at the border? If you respond quickly, you may be able to resolve the issue without having to destroy your inventory. We can help you take the right action quickly so you can get back to business.
Drug and dietary supplements: Unlike for humans, there is no dietary supplement category for animal products in FDA regulations. This means that if your food’s claims go too far, it may be categorized as a drug. We’ll help you review your supplement packaging and promotional material, and show you how to enter the market.
Don’t let the miscategorization of your animal products land you in trouble with the FDA. Contact us to get a better handle of the regulations so you can increase your market share.
How We Help
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Expert knowledge of FDA regulations that helps you strategically grow your business
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
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.
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)
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.