Food and drug law, as the practice is commonly known, actually encompasses much more than the regulation of food and drugs. In reality, the practice includes the regulation of many other consumer products such as medical devices, food additives, color additives, veterinary medicines, cosmetics, and biologics. Baker & Daniels' professionals counsel, problem-solve, and (as necessary) litigate on the full range of FDA requirements, including good manufacturing practices, pre-market notifications, pre-market approvals, investigational device exemptions, clinical trials, post-market surveillance, medical device reporting, device tracking and advertising and promotion (including FTC requirements).
Counseling
Baker & Daniels advises clients who produce regulated consumer products on how to fully comply in a cost-effective manner with the numerous and complex state and federal regulations covering these products. In particular, we offer counseling on compliance with regulations covering:
- Good manufacturing practices;
- Advertising;
- Labeling;
- Packaging;
- Food safety, standards and composition;
- Weights and measures;
- Public disclosures; and
- Trademarks.
Administrative Negotiation
Although most of the regulatory activity regarding food, drugs, cosmetics and medical devices is initiated by the U.S. Food and Drug Administration, other agencies such as the Federal Trade Commission, the U.S. Department of Agriculture, the Consumer Product Safety Commission, the Environmental Protection Agency and various state health agencies have overlapping jurisdiction regarding these products. Resolving disputes concerning the manufacturing and selling of such consumer products often requires concurrent negotiation with several administrative agencies. Baker & Daniels offers assistance to clients in negotiating with regulatory authorities regarding matters such as:
- Routine and special inspections;
- Enforcement actions, including recalls, seizures, warning letters and withdrawal of approvals;
- Agency rulings concerning advertising and labeling claims;
- Pre-market approvals for drugs, medical devices, food additives and color additives;
- Conflicts between federal and state laws; and
- Protection of trade secrets and other confidential information disclosed to an agency.
Advocacy
Baker & Daniels drafts and submits comments on regulations proposed by governmental agencies. By notifying an agency of potential problems with the regulations before the regulations become final, the firm helps clients avoid future disputes.
Related Practices