We 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.
Our 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).
We regularly counsel 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.
We represent clients in rulemaking proceedings before federal and state agencies. We regularly draft 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.
We counsel 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 our attorneys regularly advise clients is products containing Cannabidiol (CBD). Our team is actively involved in issues around the legal use of CBD.