Dietary/Herbal Supplements, Conventional Foods, and Medical Foods

 

Bayne & Associates represents a diverse range of clients, including large, publicly traded, multi-national corporations, small to medium-sized businesses, and start-ups. We dedicate our practice to advising companies on the laws and regulations enforced by FDA, including the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the: 

​​

  • Nutrition Labeling and Education Act of 1990 (NLEA) 

  • Dietary Supplement Health and Education Act of 1994 (DSHEA) 

  • Food and Drug Administration Modernization Act of 1997 (FDAMA) 

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • Food Allergen Labeling and Consumer Protection Act of 2004

  • Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

  • FDA Food Safety Modernization Act of 2011 (FSMA) 

The FSMA amendments, signed into law on January 4, 2011, represent the most significant overhaul of food safety laws in more than 70 years. FDA has issued seven major rules to implement FSMA, including the Preventive Controls for Human Food and the Foreign Supplier Verification Programs rules.  We advise on all aspects of FSMA compliance, including the development of hazard analysis and risk-based preventive controls food safety plans, foreign supplier verification programs (FSVP), vendor qualification and supply chain issues, FDA inspections, and related issues.

 We have extensive experience in: 

  • Regulatory Status of Ingredients & Formulation Issues 

  • GRAS Notification Process

  • Reportable Food Registry

  • Food Facility Registration and Compliance with Bioterrorism Act Requirements 

  • Recalls & Market Withdrawals 

Your business success revolves around how effectively you can promote your products. We are experienced and knowledgeable in the area of developing label and marketing language that will support your company's interests in the marketplace while reducing regulatory risk.

 

  •   Review of Labels & Labeling, including Nutrition Facts 

  •   Claims Review and Substantiation 

    • Health Claims 

    • Nutrient Content Claims

    • Structure/Function Claims 

    • Assessing Substantiating Data 

    • FDA Regulation of Food/Dietary Supplement Claims vs. Disease Claims 

  •   Consumer Class Action Litigation Support 

While DSHEA is more than 20 years old, FDA's enforcement policies continue to evolve, particularly in response to negative media reports, congressional inquiries, and state Attorneys General investigations into the quality and efficacy of dietary supplements.  Managing these risks, while staying competitive, is essential to the success of dietary supplement companies and ingredient suppliers.    

We routinely advise companies on all aspects of FDA’s regulation of dietary supplements, including: 

  • Regulatory Status of Dietary Ingredients & Excipients 

  • New Dietary Ingredient/Old Dietary Ingredient Issues

  • Manufacturing, Holding and Distributing Operations - Compliance with GMP Requirements at 21 C.F.R. Part 111: 

    • ​Qualifying Vendors and Managing the Supply Chain 

    • Quality and Business Agreements with Contract Manufacturers and Suppliers 

    • Working with Analytical Laboratories & Suitability of Test Methods 

    • Standard Operating Procedures (SOPs) 

    • Record-keeping Requirements 

  • Handling FDA Inspections  

  • Responding to Warning Letters and FDA 483s 

  • Adverse Event Recordkeeping & Serious Adverse Event Reporting

  • Packaging & Labels, including Supplement Facts 

  • Labeling, Brochures, & Websites: Structure/Function Claims Review, FDA Notification and Substantiation Issues (DSHEA Compliance) 

  • Scientific and Clinical Research Matters  

With extensive experience in herbal products, we assist companies in addressing the complex quality control and claims issues presented by pharmacopoeia botanical monographs, compendial standards, laboratory testing, ingredient validation and protection against adulteration.   

​​

Advancements in nutritional science and technology have led to an increase in medical foods entering the marketplace.  At the same time, FDA continues to view the category narrowly, as evidenced in guidance issued to industry in May 2016.  Bayne & Associates has extensive knowledge of the category and insight into the agency's regulatory policies.

 

We offer clients a seasoned approach to addressing FDA issues arising from medical foods intended for the specific dietary management of a disease or health condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.  We provide legal advice with respect to medical food formulations, ingredients, labels, labeling, advertising, and related issues, including the "medical supervision" requirement.   

 

OTC Drugs

The formulation and labeling of over-the-counter (OTC) drugs are regulated primarily by the Center for Drug Evaluation and Research's (CDER's) Office of Drug Evaluation IV.  With more than 80 therapeutic categories, OTC drugs are subject to an ongoing FDA administrative review process to ensure the safety and efficacy of active drug ingredients that are amenable to self-diagnosis and use. 

Bayne & Associates advises companies engaged in the manufacture, distribution, sale, and marketing of OTC drugs on a diverse range of FDA issues, including: 

  • Regulatory status of ingredients

  • Botanical drug substances  

  • Claims and monographed conditions of use 

  • Labels, including Drug Facts and warnings 

  • Labeling and promotional materials

  • FDA drug listing requirements 

  • Establishment registration   

  • Time and extent marketing applications​

 

We advise clients on the increasingly complex regulatory and business considerations that play a role in the formulation of cosmetics as well as combination OTC drug/cosmetic products. We have extensive experience in advising companies on "promoting attractiveness" claims, effectiveness claims, and the line between drug and cosmetic claims, as well as:  

 

  • Compliance with FDA labeling requirements  

  • INCI ingredient nomenclature, the designation of botanical ingredients, and related issues 

  • Quality control and manufacturing issues 

  • Scientific and clinical research to substantiate claims

 

Cosmetics

 

We advise clients on the increasingly complex regulatory and business considerations that play a role in the formulation of cosmetics as well as combination OTC drug/cosmetic products, We have extensive experience in advising companies on "promoting attractiveness" claims, effectiveness claims and the line between drug and cosmetic claims, as well as:  

 

  • Compliance with FDA labeling requirements  

  • INCI ingredient nomenclature, the designation of botanical ingredients and related issues 

  • Quality control and manufacturing issues 

  • Scientific and clinical research to substantiate claims. 

 

Medical Devices

Bayne & Associates advises companies on the diverse legal, regulatory, and business issues that arise in connection with the development, research, sale, and marketing of medical devices, including "exempt" low risk devices, the 510(k) premarket notification and FDA clearance process, product labels and labeling, imports, post-market safety reviews, product recalls, and device promotion and advertising.  We also provide legal advice and representation to companies with respect to the negotiation, development and execution of strategic alliance agreements; supply, distribution and licensing agreements; and clinical trial agreements with contract research organizations, academic institutions, and investigators.