Quick search
CTRL+K
Quick search
CTRL+K
Global Law Experts top search results to tackle law in Food, Drug and Dietary Supplement Regulatory: Tailored solutions for every legal challenge. Let experienced lawyers guide you through legal disputes and challenges with law insights and expertise knowledge. Our members hold proven strategies and solutions for every complex legal need.
Since 2010, the Global Law Experts annual awards have been celebrating excellence, innovation and performance across the legal communities from around the world.
The Food, Drug and Dietary Supplement Regulatory Law Practice is a specialized field that provides legal counsel on the complex statutes and regulations governing the safety, manufacturing, and marketing of these consumer products. This practice is dedicated to helping companies navigate the extensive rules established by national health and safety authorities. It covers the entire product lifecycle, from the pre-market approval process for new drugs and food additives to post-market compliance. Practitioners advise on adherence to good manufacturing practices, ensure that all product labels and advertising materials are truthful and not misleading, and manage the legal process for product recalls. A critical component of this practice is representing clients in administrative proceedings and enforcement actions brought by government regulatory agencies.
This is the body of law that a government uses to oversee the safety, quality, and labeling of all food, drugs, and dietary supplements sold to the public. The primary purpose of this legal framework is to protect public health by ensuring that food is safe and wholesome, that drugs are proven to be both safe and effective for their intended use, and that dietary supplements are manufactured properly and are not marketed with false or misleading health claims.
The main legal difference is based on their intended use and the level of regulatory oversight. A drug is defined as a product intended to diagnose, treat, cure, or prevent a disease and must undergo a rigorous pre-market approval process by a national health agency to prove its safety and efficacy. A dietary supplement is intended only to supplement the diet. It cannot legally claim to treat a disease and generally does not require pre-market approval to be sold.
The general process for new drug approval is a long and rigorous multi-stage procedure. It begins with pre-clinical laboratory research. If this research is promising, the developer must seek permission from a national health regulator to begin clinical trials in humans. These trials proceed through several phases to gather data on the drug’s safety and effectiveness. Upon successful completion of the trials, the developer submits all of its data to the regulatory agency for a comprehensive review before the drug can be approved for public use.
The general rules for food and supplement labeling mandate that all information must be truthful and not misleading. Labels are legally required to display specific information, such as the product’s identity, the net quantity of contents, and a complete list of ingredients. For supplements, a “supplement facts” panel is also required. Critically, supplement labels are legally prohibited from making direct claims that the product can diagnose, treat, cure, or prevent any specific disease.
Global Law Experts is dedicated to providing exceptional legal services to clients around the world. With a vast network of highly skilled and experienced lawyers, we are committed to delivering innovative and tailored solutions to meet the diverse needs of our clients in various jurisdictions.
Send welcome message