About Jacqueline Kuler
Jacqueline Kuler has extensive experience advising food, beverage, dietary supplement, cosmetic, OTC, and homeopathic drug companies on FDA/FTC compliance and marketing matters. For nearly two decades, she has helped entrepreneurs bring their innovative products to market with the assurance that they comply with applicable legal requirements. She loves what she does and has a genuine passion for working with companies in the FDA-regulated industries.
Jacqueline’s practice focuses on assisting companies in complying with regulatory requirements applicable to manufacturing, marketing, and distributing foods, beverages, dietary supplements, cosmetics, and OTC and homeopathic drugs. She advises clients at all stages of product development, including determining proper category placement and whether premarket notifications may be required, assessing the GRAS and NDI/ODI status of food and supplement ingredients, reviewing product labels and labeling to assure compliance with applicable laws and regulations, and reviewing marketing claims and substantiation to ensure they are adequately supported.
Jacqueline also has considerable experience helping clients resolve enforcement actions and investigations initiated by the FDA, FTC, NAD, and state attorneys general, including responding to 483s and Warning Letters, civil investigative demands, and cease and desist requests. She has guided many clients through product recalls and situations involving product complaints and adverse events. She also advises clients regarding applicable cGMP and quality/preventative control requirements and helps them ensure their SOPs meet regulatory requirements. Jacqueline also assists clients in various business matters associated with manufacturing, marketing, and distributing FDA-regulated products, including drafting and negotiating contracts and supply, quality, and distribution agreements.
Jacqueline understands her clients’ passion for the products they are bringing to market. If you are seeking to bring an FDA-regulated product to market, Jacqueline has the experience you need to help you navigate the complex legal environment and ensure your product meets regulatory requirements.
