Samuel D. Jockel

Partner,

Washington, D.C.

Phone: +1 202 239 3037
Email: sam.jockel@alston.com

Combining his previous roles at both the FDA and USDA, Sam brings an insider perspective to clients navigating complex regulatory compliance, enforcement, public policy and litigation issues.

Food and Dietary Supplements

Representing a major consumer packaged goods (CPG) company on interactions with the FDA and HHS related to the FDA’s self-generally-recognized-as-safe (GRAS) proposed rule.
Advising quick service restaurant chains, manufacturers, and distributors on state extended producer responsibility (EPR) compliance.
Counseling food and dietary supplement marketers on regulatory compliance and risk mitigation strategies associated with product labeling and advertising claims. This work includes extensive experience advising alcoholic beverage companies regulated by the FDA and/or TTB.
Representing major food packaging suppliers, food and beverage marketers and retailers in response to threatened or actual consumer class action, NGO, and competitor litigation before the National Advertising Division (NAD) of the Better Business Bureau. This includes successful pre-litigation resolution to a broad spectrum of challenges involving labeling and marketing claims, including health halo and natural claims, product origin claims, environmental and “green” claims, ingredient (flavor, protein, sugar) claims, and the presence of alleged contaminants, such as PFAS, phthalates, and heavy metals.
Counseling clients on the regulatory and litigation landscape surrounding the development and marketing of novel products, including alternative proteins, bioengineered foods, intentional genomic alterations in animals, and CBD/hemp-containing products. This includes advice on self-GRAS determinations and the submission of Food Additive Petitions.
Drafting public comments on behalf of clients in response to rulemaking proceedings, including in response to the FDA’s proposed update to the use of the term “healthy” on food labeling.
Negotiating various transactional agreements including purchase orders, purchase agreements, and distribution agreements on behalf of companies across the supply chain.
Advising food retailers, including restaurants, kitchens, and third-party delivery services on navigating local and state food and food packaging regulatory requirements.
Advising brick-and-mortar and online food retailers on compliance with the USDA’s Supplemental Nutrition Assistance Program (SNAP).
Advising a dairy producer on FDA and analogous state regulatory requirements, including those related to the Pasteurized Milk Ordinance.

Assisting clients in the food contact industry in obtaining Food Contact Notifications (FCNs) to obtain premarket clearance for food contact substances.
Counsel to infant formula manufacturers on FDA regulatory compliance and enforcement matters.
Assisting clients in the evaluation of the regulatory status of human and animal food ingredients and food contact substances, including in preparation of GRAS self-determinations and in food additive petitions.
Advising ingredient suppliers, food processors, and food warehouses on food safety obligations under the Food Safety Modernization Act, including preparing food safety plans for compliance with Hazard Analysis and Risk-Based Preventive Controls requirements.
Providing regulatory advice and due diligence on mergers and acquisitions in the food and dietary supplement industries.
Counseled a client on engaging with the FDA in response to a foodborne illness outbreak investigation and issuance of a warning letter, including drafting a response letter that averted further enforcement action.
Represented numerous clients to obtain release of detained products held by the FDA at import.
Represented a produce grower in petitioning the USDA’s National Organic Program in obtaining reinstatement of the client’s organic certification following suspension by an organic certifying agent.
Negotiated a settlement with the Agriculture Marketing Service regarding alleged violations of the USDA National Organic Program.

Cosmetics and Drugs

Assisting cosmetics companies on developing marketing claims to minimize regulatory and litigation risk and advising on the regulatory status of ingredients.
Advising manufacturers on compliance with OTC monograph requirements.
Advising clients on compliance obligations surrounding the Modernization of Cosmetics Regulation Act of 2022.
Representing domestic and foreign pharmaceutical manufacturers in FDA inspections, responses to Form 483 and warning letters, and preparation for FDA regulatory meetings.
Represented an individual in DOJ, DEA, and state medical board investigations involving alleged drug misbranding violations.

Animal Products and Agribusiness

Representing clients in the animal food industry on pathways to market, including GRAS notices, animal food additive petitions, and animal food ingredient consultation (AFIC).
Advising marketers of animal health products on regulatory compliance and risk mitigation strategies associated with product labeling and advertising claims.
Assisting marketers of pet food and animal feed on navigating state animal feed regulatory requirements and responding to enforcement actions.
Defended and resolved a major administrative action brought by the USDA under the Animal Health Protection Act and Plant Protection Act for the importation of animal-derived products.
Represented a farmer in appeal of an action involving the Farm Service Agency (FSA) at the USDA National Appeals Division (NAD).

Samuel D. Jockel

Food and Dietary Supplements

Cosmetics and Drugs

Animal Products and Agribusiness

Bar Admissions

Education

Memberships