Food and Drug Law

Ryley Carlock & Applewhite helps clients navigate complex federal food and drug laws relating to the manufacture, labeling, importing, marketing and sales of: ingredients, dietary supplements, pet supplements, sports drinks, organic foods, functional foods, infant formulas, cosmetics, "cosmeceuticals," aromatherapy, over-the-counter drugs, homeopathic drugs, medical devices and medical foods. The firm has special expertise in biotechnology and nanotechnology issues, as well as strong support in business law, advertising law, and litigation. Beyond FDA-regulated health and beauty products, the promotion of virtually all consumer products and services are regulated by the Federal Trade Commission (FTC). Working in close collaboration with our other practice groups, we help you to reduce regulatory enforcement risk and liability risk throughout a product's life cycle, while simultaneously protecting your intellectual property-- thereby building and preserving the value of the brand.

From premarket clearance requirements through manufacturing and marketing, we bring a broad business and legal understanding to help clients achieve their R & D and financial objectives in dealings with the FDA and with their customers. We assist in:

  • New product launch and new labeling claims (USDA, FTC, EPA, WHO, etc.)

  • Opinion letters as to the proper category for a new sports drink or medical device

  • Evaluating new ingredients, NDI Notifications (for supplements), and GRAS self-affirmations (for foods)

  • R&D assistance and legal advice for medical foods—a category with few official regs

  • On-going compliance counsel and risk assessment and management

  • Preparing and filing formal comments to Proposed Rules for new regulations

  • Compiling and assessing claims substantiation files

  • Defending labeling and marketing claims, e.g., re. FDA Warning Letters

  • Defending inspections—both annual FDA and supplement GMPs audits

  • Obtaining release of detained shipments (including via Customs)

  • Recalls, post-market reporting, and crisis management

Whether it is assistance in determining which regulatory category or path to pursue, advice on effective strategies to obtain pre-market clearance for a new product, assessment of regulatory and business risks associated with a particular strategy, help in resolving an FDA enforcement matter, or counsel in dealing with public policy issues, we have experienced lawyers who provide knowledgeable, pragmatic, and multi-faceted advice. Beyond FDA law, we combine expertise in intellectual property, corporate, litigation, and advertising (FTC) law to assist our clients with full service strategies and solutions.

Our partners in the business group assist our FDA and advertising clients with counsel on and drafting of various types of contracts, including: Non-Disclosure Agreements (NDAs), Independent Consultant Contracts, Licensing Agreements, Manufacturing Agreements, and Distribution Agreements. Our award-winning litigators provide negotiation and trial expertise for a myriad of commercial and contract disputes, as well as trade secret and trademark infringement cases, and product liability suits.

The FDA and the FTC have joint jurisdiction over most consumer health and beauty products. And the Consumer Protection branch of the Federal Trade Commission (FTC) has an even broader reach, as it oversees and regulates all promotional materials for virtually all consumer products and services (except for prescription drugs and medical devices). Thus, any client that markets products or services to consumers will at some point require counsel on how to be and stay in compliance with FTC regulations and guidelines. The principles and guidelines on advertising law are applicable, and indeed crucial, in businesses from weight loss aids to household and manufactured goods, through electric power.

The advertising law section of our FDA/ FTC law practice area advises clients on all types of regulatory compliance for the following aspects of marketing:

  • Green claims—for recycling, sustainability, etc. in manufacture and packaging

  • Free offers, discounts and special offers

  • Disclaimers and disclosures of various sorts

  • Judging allowed vs. disallowed claims for a particular product

  • Contest rules (where the contest is used for promotion)

  • All promotional materials

  • Corrective advertising (if forced to make corrections, based on a settlement or judgment)

Promotional materials are conveyed via many channels and media—all of which our attorneys cover:

  • Social media advertising, including blogs, Facebook, and Twitter

  • Website content

  • Telemarketing

  • Print ads and brochures

  • Billboards

  • Radio and TV spots

  • Infomercials and Scientific Reports used for marketing

  • Exhibit booth materials at trade shows and conferences

  • Consumer testimonials

  • Expert endorsements, including celebrity endorsements

Of course, we counsel our clients to be in compliance with federal and state regulations and guidelines, but when our clients' competitors run afoul of the laws on advertising and fair business practices, we work collaboratively with our litigation group on all adversarial actions from cease and desist letters and negotiated settlements through jury trials.

We also vigorously defend our clients in the face of various types of investigations and complaints:

  • FTC Investigations

  • FTC Consent Decrees

  • Lanham Act cases

  • State AG Complaints, e.g., re. false or unsupported advertising

  • State codes on Unfair Business Practices

  • Complaints from the Better Business Bureau, especially the National Advertising Division (NAD)

Closely related to our counsel on advertising law and its disputes is our IP expertise—involving advice as on best practices in branding, trademarks, service marks and advertising slogans, copyright of websites and brochures, and protection of other intellectual property, such as images and photographs. Again, working with our litigation group, we have prevailed in many patent, trademark and copyright infringement cases. Our overall goal is to help our clients--whether large corporations or small start-ups--achieve their R & D, marketing, and financial objectives in the face of complex state, national, and global regulatory structures and strictures.

 

 

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