Toolkit

Services

Here’s how we provide clients with peace of mind.

Our areas of expertise

Food and Beverage

Food and beverage companies have to navigate complex regulations, thin margins, and several competitors. We offer a broad range of international legal and regulatory services for the production and marketing of finished food, food ingredients, and food contact materials like packaging.

Supplements

The FDA regulates functional foods, dietary supplements, and natural remedy products distributed in the U.S. They have recently stepped up the enforcement against companies for safety and labeling violations. We can ensure your compliance with Part 111, labeling and claims, and other regulations.

Drug

Over-the-counter (OTC) drugs and homeopathic drugs that comply with FDA regulation do not need to be approved by the FDA before they are marketed. We help you understand those strict regulations so that you can avoid enforcement actions by the FDA. From label reviews to export certificates, we can help.

Medical Device

If you’re developing, manufacturing, or marketing a medical device, you need in-depth understanding of the FDA regulatory process. We provide counseling and advocacy on FDA medical device matters, including device clearance (510(k), PMA, etc.), and enforcement and compliance issues.

Cosmetic

The differences between a cosmetic product and an OTC drug product often come down to the language used to describe them. We walk you through what language you can and cannot use when packaging and marketing your cosmetics products. We also assist with ingredient review, label review, and more.

Tobacco and E-Cigarette

We advise tobacco product companies through the labyrinth of new FDA requirements. In addition, we offer legal support regarding statutory and regulatory requirements for a number of areas including product labeling and health document submissions.

Recalls

A recall can devastate your business’ revenue and reputation. FDA Atty can manage all aspects of a recall or adverse event and illness reporting so you can get your business back on track. We help you avoid a recall situation by ensuring you’re in compliance, and can guide you how to navigate the recall itself.

Import

Import holds can lead to costly delays and days of not knowing what to do. We can assist if you receive a Notice of Action, or are placed on an Import Alert. Enter the market seamlessly without having to worry about whether your shipment will be allowed into the country.

Inspections

Did you know that the FDA has the authority to conduct inspections without a warrant? The field officer notes any minor violations on a Form 483. If you don’t respond properly and quickly, you could end up facing a recall, Warning Letter, or worse. We help you get your business back on track after an inspection.

Animal

The FDA categorizes products for pets and animals into two categories: food and drug. This means you have to be very careful about the language you use on your labels and promotional materials. We help with label review, import and export forms, and more. 

Litigation Support and Expert Witness

FDA litigation involves a number of complex regulatory questions. If your firm does not have FDA expertise in-house, FDA Atty can provide detailed regulatory responses to ensure your litigation team has a winning strategy. We also serve as expert witnesses and mediators, and manage FDA document production and FOIA requests.

Consent Decree and DOJ Injunction

An FDA Consent Decree requires a complete halt in business operations until certain conditions are met. In order to avoid this situation, it’s important to engage counsel and respond to FDA Warning Letters or Form 483s in a timely manner. We can assist your business to keep an FDA Consent Decree from occurring.

Warning Letters

Don’t panic if you receive a Warning Letter. While it’s a serious offense, which can lead to further enforcement such as recalls and injunctions, you have options if you act fast. Get in touch with FDA Atty so we can ensure your response to the Warning Letter contains the information the FDA requires.

Need a strategy to navigate the FDA rules and regulations that apply to your business?