FDA and USDA Compliance
Great advances in food, dietary supplement, drug, cosmetic and device technology and manufacturing, along with a growing demand for products focused on health and wellness, have given rise to a vast array of products designed to provide enhanced benefits to consumers. This rise has been accompanied by a parallel increase in government regulations and enforcement seeking to protect people’s health.
Amin Wasserman Gurnani has gained a strong reputation for being at the cutting edge of the food, beverage, dietary supplement, drug, device and cosmetic industries, representing some of the most innovative wellness-related companies in the world.
We provide strategic advice for clients from the inception of their product with a focus on enhancing product value, gaining regulatory approvals, ensuring compliance and avoiding consumer and competitor challenges.
- For food, supplement and cosmetic ingredients and products, beginning with initial counsel on label representations and product formulation, we advise through all aspects of product development including GRAS and NDI submissions and clinical testing and analyses.
- For medical devices, we advise on classification, 510(k) notifications and 513(g) requests.
- For OTC and homeopathic drug products, we advise on monograph and pharmacopeia compliance.
- For all product categories, we review labels, advertisements, websites and social media campaigns for FDA, FPLA, USDA and FTC compliance.
- We assist companies with FDA facility registration and product listing.
- We develop technical substantiation to support product claims made in labeling and advertising, and work with the appropriate federal agencies to gain approval of products and claims when needed.
- We counsel companies on good manufacturing practices (GMPs) to ensure quality and safety of their products.
- We advise on imports, detentions, warning letters, recalls, inspections, 483s, seizures, injunctions, import alerts, California‘s Prop 65 regulations and food safety under FSMA.
Whatever the category, with our knowledge of the regulations and deep ties to the industry, we will not only make sure you comply, we will help you succeed.
