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

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 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