Sometimes, the goal is product approval. Sometimes, it’s to protect or advance a position in the market. Occasionally, the aim is just to prevent current operations from being interrupted.
Whatever the objective, an impersonal bureaucracy involving the Food & Drug Administration ( FDA ), the United States Department of Agriculture ( USDA ), US Customs Department ( Customs ), or the Federal Trade Commission ( FTC ) will be involved, as well as those of other countries. A labyrinth of global governmental oversight can exist when dealing with a worldwide marketplace.
One of the best advantages a food or drug manufacturer, processor or distributor can have in these situations is an ally who not only is expert legal counsel, but who has career experience making her accustomed and adept in dealing with these agencies. For clients of Fuerst Humphrey Ittleman, that person is Christine M. Humphrey, Esq., head of the firm’s Food, Drug & Cosmetics team.
Please contact us today for a flat-fee initial consultation.
FHI’s approach is distinct. First, personal involvement is assured, as a core tenet of the firm is the development of personal, one-on-one relationships with each corporate client. From this, creative and proactive problem-solving can occur, as law firm and client join their respective expertise into finding the optimal result.
Second, FHI assists in the implementation of that solution once it has been found. FHI works with clients in responding to FDA 483s, warning letters, injunctions, prosecutions, detentions, refusals, Customs penalties and import alerts. The FHI team does not advise and leave.
If it’s needed, FHI will work with clients in preparing for meetings with agency personnel on compliance matters as well as representing clients before the agencies in issues of enforcement, policy and rulemaking issues and litigation. FHI will advocate for the client in the courtroom, if need be.
It is this hands-on approach, together with FHI’s extensive expertise on promotion and advertising, labeling issues, exports and imports, MDR reporting, QSR and GMP requirements and other regulatory issues that provides FHI clients with a confidence and security that their products and processes are compliant in the most cost-effective manner available.
FHI has successfully advised food, drug & cosmetic clients for many years. FHI assists both US and foreign life science companies, biomedical firms, trade associations, research institutions, individuals and consumer product industries.
Fuerst Humphrey Ittleman works with an international clientele in dealing with regulatory and legal issues related to a wide variety of products. Foods, dietary supplements, medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, animal feeds, animal drugs, cosmetics, electronic radiation products and other consumer products are all a part of FHI’s practice. Additionally, issues involving imports, criminal enforcement actions, FDA inspections, detentions, refusals and the impact of the Bioterrorism Act are also dealt with at FHI.
For more information, please contact Christine M. Humphrey, Esq. at chumphrey@fuerstlaw.com.
