Share your needs with us, get contacted by law firms.
Free. Takes 2 min.
FDA Law refers to the regulations, statutes, and policies implemented and enforced by the United States Food and Drug Administration (FDA). These laws govern the import, manufacture, distribution, labeling, advertising, and sale of food, drugs, biologic products, medical devices, cosmetics, and tobacco products. In Beverly Hills, the rules and regulations set by the FDA apply, as well as certain California-specific requirements, particularly regarding cannabis, food labeling, and medical device regulation. Businesses and individuals operating in the health, beauty, or food industries must be aware of and comply with these complex federal and state legal frameworks.
FDA Law is highly technical and constantly evolving. You may need a lawyer in situations where:
An FDA law attorney can help protect your interests, advise on regulatory compliance, and represent you in enforcement, litigation, or negotiations with regulators.
While FDA regulations are federal, California and Los Angeles County - including Beverly Hills - impose additional requirements for various FDA-regulated industries. Key areas include:
Businesses in Beverly Hills must comply with both federal FDA requirements and potentially stricter California and local rules. Coordination between federal and state compliance is critical for law-abiding operations.
The FDA regulates food, beverages, dietary supplements, drugs (prescription and over-the-counter), biologics, medical devices, cosmetics, tobacco products, and some electronic products that emit radiation.
Yes, California often has stricter standards than federal rules, especially for product labeling (like Prop 65), environmental requirements, and cannabis/CBD regulations.
A warning letter is a formal notice from the FDA indicating that your product or business has violated FDA regulations. It outlines the issues and instructs corrective actions. Failure to respond properly can result in further penalties.
Generally, cosmetics do not require FDA pre-approval before marketing, but they must be safe, properly labeled, and not make unauthorized drug claims. However, claims about treating or preventing diseases may move the product into drug regulation, which does require approval.
California permits some CBD products, but the FDA prohibits CBD in foods and dietary supplements at the federal level. Navigating compliance is complex and often requires legal guidance due to evolving laws.
Allow the inspection but consult an attorney for guidance. Maintain a record of the inspectors' findings, and make sure you respond appropriately to any corrective actions or follow-up requests.
While the FDA oversees compliance directly, state agencies like the California Department of Public Health and Los Angeles County Department of Public Health play key roles in enforcement and local inspections, especially for food and drug safety.
No pre-approval is needed for dietary supplements, but they must be manufactured according to FDA standards and cannot make false or misleading claims. New ingredients may require notification to the FDA.
Prop 65 is a California law requiring warnings on products that contain chemicals known to cause cancer or reproductive toxicity. It often overlaps with FDA regulations and can create additional compliance challenges.
Contact an FDA law attorney immediately. Preserve all documentation, conduct an internal review, and promptly follow legal and regulatory instructions to avoid further penalties or business interruption.
Consider reaching out to these agencies and organizations for further information:
If you believe you need legal help with an FDA law issue in Beverly Hills, start by gathering all relevant documents, communications, and records related to your product or business concern. Write down your specific questions or concerns. Then:
Timely legal guidance can help you prepare, avoid costly missteps, and resolve any regulatory challenges efficiently.
