Emord & Associates’ Food and Drug lawyers represent individuals and companies before the Food and Drug Administration (FDA) on issues involving:
- Government inspections
- Good Manufacturing Practices (CGMP)
- Food and drug labeling, health claims
- Structure/function claims
- Premarket approval applications
- Investigational new drug applications
- Investigational device exemptions
- New product development protocols
- Personal use importation of unapproved drugs
- Compassionate use exemptions
- Regulations governing clinical trials
- Pharmacy Compounding
- Homeopathy, including homeopathic product reviews
- GRAS petitions and GRAS status determinations
- New dietary ingredient (NDI) submissions
- Adulteration and misbranding violations
- Warning Letters and FDA Form 483s
- Federal Food Drug and Cosmetic Act (FDCA)
- FDA Bioterrorism Act of 2002
- Nutritional Labeling and Education Act (NLEA)
- EFSA and EU regulations
- California Proposition 65 Compliance
- Clinical trials and Institutional Review Boards (IRBs)
- and product import/export issues.
The firm’s FDA lawyers draft and file petitions, applications, comments, and requests for advisory opinions and stays to the agency. The FDA attorneys of Emord & Associates counsel clients on FDA inspections and on compliance with FDA Good Manufacturing Practice Guidelines. The law firm routinely reviews the labels, labeling, and advertising of hundreds of clients under applicable federal regulations. The firm represents a wide range of clients on FDA regulatory matters including food, drug, and dietary supplement companies, scientists: physicians, patients: consumers and holistic and alternative practitioners. The firm’s broad regulatory practice touches upon myriad products ranging from Human Chorionic Gonadtropin (hCG), weight loss dietary supplements, over-thecounter drugs including hormone products, nutritional supplements, botanicals, and medical devices).
The FDA lawyers of Emord & Associates have been at the center of most legal issues governing the regulation of foods, dietary supplements, and drugs in the United States, Firm principal Jonathan Emord was consulted by members of Congress during debates over the content of the Dietary Supplement Health and Education Act (DSHEA) and voiced objections to specific provisions of the law that invited overregulation of the industry before the bill’s passage. Emord has assembled teams of scientists to evaluate the effects on disease of nutrients and has filed more health claim petitions than any other law firm.
Emord has successfully pursued health claims for folic acid reducing the incidence of neural tube defects, antioxidant vitamins reducing the risk of cancer, omega-3 fatty acids reducing the risk of coronary heart disease, phosphatidylserine reducing the risk of dementia, vitamins B6, B12, and folic acid reducing the risk of coronary heart disease. selenium reducing the risk of cancer, among others. The law firm has defeated the Food and Drug Administration (FDA) a remarkable seven times in federal court, five times on First Amendment grounds.
Emord was among a small group of counsel who helped draft and prepare oral argument in the successful Western States Medical Center case before the United States Supreme Court. Emord is frequently consulted by media concerning the meaning and effect of regulations that have an impact on food, drug, and dietary supplement markets. He regularly writes and lectures on issues pertaining to food, drug, and dietary supplement regulation.
Emord & Associates represents clients on issues involving the Environmental Protection Agency, including pesticide registration and child resistant packaging under the Consumer Product Safety Improvement Act.
The firm counsels clients on issues concerning pet food supplements, feed supplements, and animal drugs. The firm assists clients with petitions to the Association of American Feed Control Officials (AAFCO) for feed ingredient approval, and assists clients with GRAS affirmations under the FDA’s Center for Veterinary Medicine’s (CVM) grass affirmation procedure. Emord & Associates assists clients with the animal drug approval process. The firm handles appeals and judicial review of FDA decisions concerning animals.
- PRESS RELEASE: Jonathan Emord Goes Round Two with the FDA on Electroshock Devices
- Jonathan Emord, “The FDA’s bow to barbarism” (Washington Times, Oct. 12, 2016)
- FDA, straighten up! Attorney Jonathan Emord takes on FDA over shock therapy (ECT)
- PRESS RELEASE: Attorney Jonathan Emord Takes on the FDA Over Electroshock (ECT) Device
- Proposed Federal Bill Would Prevent States, FDA, And Anyone Else From Informing Consumers Whether Food Is Bioengineered
- Emord Interview in Freedom From Choice to Appear on the Stossel Show
- FDA Requests Nominations for Drug Compounding List
- Experts Recap Oral Arguments Before the Supreme Court in POM v. Coke
- Attorney Bethany R. Kennedy Comments on NDI Notifications
- Attorney Peter Arhangelsky Comments on Upcoming POM v. Coke Decision