Compliance / Regulatory: Products and Labeling: Calfee

Manufacturers, distributors and sellers of products are governed by various federal and state agencies that work to ensure strict compliance with relevant laws and regulations. Different agencies are tasked with governing different types of products, for example:

The Consumer Product Safety Commission governs all consumer products used in the home and enforces the Consumer Product Safety Act and the Federal Hazardous Substances Act, which governs all products determined to contain a hazardous substance under federal law.
The Food and Drug Administration governs all food, drugs, cosmetics and medical devices and enforces the Food, Drug and Cosmetics Act.
The National Highway Transportation and Safety Administration governs all vehicles, automotive parts and automotive accessories (even floor mats) and enforces the National Motor Vehicle Safety Act
The California Office of Environmental Health Hazard Assessment (OEHHA) oversees Proposition 65, which governs all products, wherever manufactured, that are sold in the state of California and that contain certain chemicals.
The U.S. Environmental Protection Agency governs pesticides, fertilizers and similar products and enforces the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

Each of these agencies abides by a network of regulations that govern proper classification of the products under their control, the registration (when necessary) and marketing of such products, the application of warning labels and procedures for the recall of misbranded, adulterated or defective products. Participants in the distribution chain must likewise abide by common law warning standards where not preempted by federal law.

As part of our larger products liability and intellectual property practices, we work with manufacturers, sellers and patent holders to comply with government regulations and standards in the industry, to maintain the safety of their products, and to resolve disputes with governmental agencies when they inevitably arise. In addition to counseling clients concerning the proper labeling of their products to avoid litigation, we also defend lawsuits containing issues related to the potential hazards associated with a client’s products and the failure to warn of those hazards.

Services

Our services include:

Consultation concerning the applicability of law to a client’s products.
Design of clear, concise and easily understood warnings meant to advise users of dangers associated with products and avoid liability.
Creation and maintenance of proper labeling for products including consumer products, auto supplies, food, pharmaceuticals and fertilizers.
Consultation concerning the propriety and necessity of product recalls.
Design of an appropriate and cost-effective recall plan when a recall cannot be avoided.
When necessary, implementation and oversight of recalls in the most efficient and economical way possible.
Negotiation with federal and state agencies that regulate products to resolve disputes concerning any alleged violation of law or breach of a recall agreement.
Litigation against government entities and private parties bringing claims that products were misbranded, adulterated or mislabeled.