By Sheldon Baker11.14.24
Ashish Talati is a founding member at the New York- and Chicago-based Talati Law Firm PLLC. He is one of the industry’s foremost experts on FDA regulatory matters. Talati primarily counsels companies and trade associations in the food, dietary supplement, cosmetic and medical device industry on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning and advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal and state agencies, as well as in court.
Health E-Insights (HEI): Please provide an overview of your new law firm.
Talati: At Talati, we get how crucial it is for businesses in food, beverages, dietary supplements, cosmetics, OTC drugs, and medical devices to play by the FDA’s rules. We serve as a personal guide ensuring compliance without cutting corners and keeping risk low and confidence high. We bring clarity and confidence to clients wandering in regulatory mazes. Our services include compliance assessments and roadmap, essentially helping clients develop comprehensive compliance frameworks encompassing everything from creating specific compliance reviews, internal policies, and training geared towards meeting all the necessary FDA/FTC standards throughout their operations. We also perform due diligence reviews for the buy and sell side, labeling and advertising reviews including accurate ingredient labeling, health claims, and advertising disclosures.
My partner, Brad Staubus, is a seasoned transactional and business lawyer concentrating his practice in complex business matters and commercial litigation across various industries. He is a strategic legal advisor and general corporate counsel to CPG brands, food and beverage entrepreneurs, and investors. He advises clients on quality and supplier agreements as well as manufacturing agreements.
HEI: What challenges are you facing as a start-up?
Talati: I have been practicing in this amazing industry for almost 20 years, which made my transition very smooth. I’m fortunate to have incredible clients, friends, and industry colleagues who have supported me throughout the years.
HEI: What is your key area of expertise?
Talati: In a nutshell, regulatory compliance and ingredient safety. My expertise includes counseling clients on all aspects of dietary supplements and functional foods, including ingredients, safety testing, GRAS (Generally Recognized As Safe) or NDI (New Dietary Ingredient) status, claims, classification, and compliance with good manufacturing practices (GMPs). Also, the types of claims that may appear in advertising and on labeling, in addition to promotional materials for these products, including the claims used to market dietary supplements online. I review client labels, labeling, and advertising for product compliance issues and advise on the classification of a product as a dietary supplement or a conventional food based on the product ingredients and claims.
HEI: Do you represent global clients entering the U.S. nutraceutical market?
Talati: Absolutely. I would say 30% of our firm’s clients are international companies entering the U.S. market. Most of our international clients are from Japan, South Korea, Europe, Australia, China, India, Israel, Canada, and Mexico.
HEI: What other industries fall under your expertise?
Talati: Food and beverages, cosmetics, OTC drugs, and medical devices.
HEI: What do you see as the major issues/trends in front of nutraceutical companies?
Talati: We are seeing more and more states pass regulations that affect the dietary supplement industry, with New York's legislation on specific weight loss and muscle-building supplements being just the start. This trend reflects a growing emphasis on consumer safety and transparency in product efficacy. As additional states implement similar measures, companies may face a complex array of regulations that complicate product formulation, marketing, and distribution. The recurring introduction of the product listing bill in Congress adds another layer of complexity to the dietary supplement industry at the federal level.
HEI: What do you find most challenging?
Talati: I think lately it’s been challenging to keep up with all the regulations that affect the food and supplement industry at the state level.
Health E-Insights (HEI): Please provide an overview of your new law firm.
Talati: At Talati, we get how crucial it is for businesses in food, beverages, dietary supplements, cosmetics, OTC drugs, and medical devices to play by the FDA’s rules. We serve as a personal guide ensuring compliance without cutting corners and keeping risk low and confidence high. We bring clarity and confidence to clients wandering in regulatory mazes. Our services include compliance assessments and roadmap, essentially helping clients develop comprehensive compliance frameworks encompassing everything from creating specific compliance reviews, internal policies, and training geared towards meeting all the necessary FDA/FTC standards throughout their operations. We also perform due diligence reviews for the buy and sell side, labeling and advertising reviews including accurate ingredient labeling, health claims, and advertising disclosures.
My partner, Brad Staubus, is a seasoned transactional and business lawyer concentrating his practice in complex business matters and commercial litigation across various industries. He is a strategic legal advisor and general corporate counsel to CPG brands, food and beverage entrepreneurs, and investors. He advises clients on quality and supplier agreements as well as manufacturing agreements.
HEI: What challenges are you facing as a start-up?
Talati: I have been practicing in this amazing industry for almost 20 years, which made my transition very smooth. I’m fortunate to have incredible clients, friends, and industry colleagues who have supported me throughout the years.
HEI: What is your key area of expertise?
Talati: In a nutshell, regulatory compliance and ingredient safety. My expertise includes counseling clients on all aspects of dietary supplements and functional foods, including ingredients, safety testing, GRAS (Generally Recognized As Safe) or NDI (New Dietary Ingredient) status, claims, classification, and compliance with good manufacturing practices (GMPs). Also, the types of claims that may appear in advertising and on labeling, in addition to promotional materials for these products, including the claims used to market dietary supplements online. I review client labels, labeling, and advertising for product compliance issues and advise on the classification of a product as a dietary supplement or a conventional food based on the product ingredients and claims.
HEI: Do you represent global clients entering the U.S. nutraceutical market?
Talati: Absolutely. I would say 30% of our firm’s clients are international companies entering the U.S. market. Most of our international clients are from Japan, South Korea, Europe, Australia, China, India, Israel, Canada, and Mexico.
HEI: What other industries fall under your expertise?
Talati: Food and beverages, cosmetics, OTC drugs, and medical devices.
HEI: What do you see as the major issues/trends in front of nutraceutical companies?
Talati: We are seeing more and more states pass regulations that affect the dietary supplement industry, with New York's legislation on specific weight loss and muscle-building supplements being just the start. This trend reflects a growing emphasis on consumer safety and transparency in product efficacy. As additional states implement similar measures, companies may face a complex array of regulations that complicate product formulation, marketing, and distribution. The recurring introduction of the product listing bill in Congress adds another layer of complexity to the dietary supplement industry at the federal level.
HEI: What do you find most challenging?
Talati: I think lately it’s been challenging to keep up with all the regulations that affect the food and supplement industry at the state level.
