Dietary Supplements

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), consumers have driven annual sales in the industry from around $4 billion to upwards of $40 billion, the number of products from around 6,000 to over 50,000. With that growth comes new legal and regulatory challenges in the dietary supplement market. While DSHEA is celebrating its 25th anniversary in 2019, AGG’s attorneys have been serving the needs of the dietary supplement industry for over 20 years. They have advanced and defended supplement suppliers, manufacturers, distributors and sellers. Based in Washington, they have a deep understanding of the market and the many legal, regulatory, business, and public policy issues that must be navigated by well-established and start-up companies. AGG provides supplement clients with the full range of services they need at every stage of their development, including corporate, intellectual property, regulatory compliance, and litigation.

INTELLECTUAL PROPERTY

AGG’s attorneys, including those with advanced science degrees and registered to practice before the U.S. Patent and Trademark Office (USPTO), offer full-service representation in patent, trademark, copyright, trade secret and unfair competition law to dietary supplement companies.

We provide fundamental services including U.S. and foreign patent and trademark preparation and prosecution, copyright registrations, litigation, freedom to operate opinions, licensing, transactions, due diligence, and strategic portfolio management. We have particular expertise in handling more specialized matters including complex administrative proceedings before the USPTO such as inter partes reviews (IPRs) reexaminations, reissues, interferences and appeals to the Board of Patent Appeals, as well as federal district court litigation, appeals to the U.S. Court of Appeal for the Federal Circuit and investigations before the International Trade Commission.

AGG has advised and represented numerous dietary supplement clients in patent, trademark, trade secret, unfair competition and copyright cases in several courts around the country. When a dispute arises, AGG’s experienced litigators work closely and collaboratively with the client to reach a successful resolution.

REGULATORY AFFAIRS

AGG’s attorneys regularly represent dietary supplement companies that have issues before federal and state government agencies, including the Food and Drug Administration (FDA). Federal Trade Commission (FTC), Department of Justice (DOJ), Department of Agriculture, Department of Commerce, Department of Defense, Drug Enforcement Agency, Customs and Border Protection and state attorneys’ general.

AGG’s Dietary Supplement team is bolstered by the presence of former FDA officials, including the former Deputy Director of the Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, as well as attorneys from the Office of Chief Counsel and the Office of Regulatory Policy within FDA’s Center for Drug Evaluation and Research (CDER).

AGG regularly counsels dietary supplement clients on complying with DSHEA and other statutes and agency rules and guidance. For example, AGG advises clients on complying with FDA and FTC requirements in areas such as advertising and promotion, claim substantiation, health claims, label and labeling, current good manufacturing practice (cGMP), warning letters, seizures, injunctions, Form 483 inspection notices, and import alerts and bulletins. AGG also handles investigations by the DOJ and state AGs that are conducted in parallel with the FDA or FTC.

AGG represents clients in rulemaking proceedings before federal and state agencies. AGG regularly drafts comments on proposed rules, policies, and guidance documents. For example, AGG participated with Natural Products Association on the FDA’s revised New Dietary Ingredient (NDI) Guidance shortly after it was issued. It has regularly prepared Citizen Petitions at FDA.

AGG counsels clients on NDI issues and works directly with clients and scientists to draft and file new dietary ingredient (NDI) notifications (NDIN) with FDA. AGG has a unique presence in the dietary supplements space that allows it to provide guidance and advice on every stage of bringing an NDI to market; from concept, to pre-clinical and clinical study design, to preparing the NDIN. For example, AGG attorneys filed an NDIN for beta-alanine on behalf of one of its clients, which received an Acknowledge Without Objection (or AKL) letter from FDA in February 2019. AGG also works closely with clients on generally recognized as safe (GRAS) determinations.

Another area where AGG attorneys regularly advise clients is products containing Cannabidiol (CBD). AGG is actively involved in issues around the legal use of CBD.

LITIGATION

AGG has a deep bench of attorneys in litigating intellectual property, false advertising, unfair competition, consumer fraud, breach of contract, class action and product liability defense cases. Our knowledge of supplements, the science behind them, combined with our experience in litigation and the regulatory framework, provide clients with an added value that helps resolve disputes more efficiently.

PROPOSITION 65

AGG not only advises clients regarding compliance with Proposition 65, it has also litigated warning letter cases in California courts. With regulators issuing new rules on a more frequent basis, clients can expect to have additional challenges in this area in the coming years.

PUBLIC POLICY

AGG advises dietary supplement companies and associations on legislative matters before the U.S. Congress that affect their interests. We are in regular contact with Congressional Members, committees and staff to provide subject matter expertise on pending or suggested legislation and investigations.