Emord & Associates is dedicated to serving the needs of its national client base. The firm’s attorneys represent clients in constitutional and administrative law cases before the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ), the Department of the Interior, the Bureau of Land Management (BLM), the National Park Service (NPS), the Equal Employment Opportunity Commission, the Environmental Protection Agency (EPA), and the Federal Communications Commission (FCC).

FDA  | USDA | Import | Export | FTC | Advertising | Compliance | Dietary Supplements | Foods | Labeling | Prescription & OTC Drugs | Cosmetics | Animal Feeds & Supplements | DEA  | Controlled Substances | Medicare | Licensing | Commercial Litigation | Contracts | Business | Civil Litigation | Constitutional Law


Copyright © 2010 Emord & Associates, P.C.  All rights reserved | Sitemap  | Washington, D.C. | Virginia | Arizona

PRACTICE AREAS

Food, Drug, and Cosmetic Law

Advertising Law

Unfair Competition

Import | Export

DEA & Controlled Substances

Medicare Law

Medical Licensing Law

Constitutional Law

Legislative/Constitutional Drafting

General Civil Litigation

Appellate Practice

Communications

Federal Land Management

ADDRESSES:

VIRGINIA (Firm HQ)

11808 Wolf Run Lane

Clifton, VA 20124


WASHINGTON D.C.

1050 Seventeenth Street, N.W.

Suite 600

Washington, D.C. 20036


ARIZONA

3210 South Gilbert Road

Suite 4

Chandler, AZ  85286


Telephone: (202) 466-6937

Telecopier: (202) 466-6938

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


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-the-counter 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 animal supplements, feed, and drugs.

FDA regulation of “dietary supplements”


Food Facts:  Dietary Supplements, What You Need to Know


FDA Guidance and Regulatory Information


FDA GRAS Status (Generally Recognized As Safe)


Federal Food, Drug, and Cosmetic Act (FDCA)


Dietary Supplement Labeling


FDA Dietary Supplement Question and Answer


New Dietary Ingredients (NDI) in Dietary Supplements


Consumer Information on FDA Regulated Drug Products


FDA Drug Approvals


FDA Regulation of Cosmetics and Color Additives


Cosmetic Labeling


FDA Regulation of Pet Foods & dietary supplements

Food, Drug, and Cosmetic Law

Food, Drug, and Cosmetic Law Frequently Asked Questions (FAQs)

Q:  Will I need to submit a new dietary ingredient notification for my products that have already been marketed?


Q:  I just received a Warning Letter from the FDA, do I need an attorney?


Q:  Will I always receive a Warning from FDA before the agency takes enforcement action?


Q:  Will the FDA inspect my company?


Q:  What should we do when the FDA arrives for an inspection?


Q:  The FDA says my product is adulterated and/or misbranded.  What sort of consequences am I facing?


Q:  How can I be certain that my business is in compliance with the new dietary supplement cGMP regulations?


Q:  We have another company manufacture and ship our private label products directly to consumers.  Are we covered by the FDA’s new cGMP regulations?


Q:  Should I have my product labels reviewed before I market my product?


Q:  What sort of advertising claims can I make about my dietary supplement?


Q:  Will the FDA look at my website?


Q:  Must the FDA preapprove the ingredients in my dietary supplement?


Q:  How can I tell if my product contains a New Dietary Ingredient (NDI)?


Q:  What does “GRAS” stand for, and when do I need to be concerned about it?


Q:  How can we petition FDA for a health claim?


Q:  If my dietary supplement is lawful for sale in the United States, can I sell it in Europe as well?


Q:  How do I know if my product is regulated under California’s Proposition 65? How do I know if my consumer warning complies?


Q:  Does FDA regulate pet food supplements differently from human dietary supplements?


Q:  Do I need FDA preapproval of my Cosmetic or topical product?


See more FAQs

Food and Drug Law

Resource Links