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


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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

The cGMP Kit


In its rule, FDA admits that the regulations:



Moreover, the FDA admits that the regulations will impose the greatest economic burden on very small (20 or fewer full time employees) and small (500 or fewer employees) dietary supplement companies.


In July 2007, the FDA promulgated comprehensive “cradle to grave” regulations that govern every aspect of the manufacture, holding, and distribution of dietary supplements.


We commissioned Dr. Steve Hanke, former Senior Economist on President Reagan's Council of Economic Advisers, to evaluate the economic impact of the regulations and he predicts the burden will be approximately ten-fold higher than FDA has predicted.

These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes. They mandate new testing, master manufacturing records, complaint records, disposition records, and new procedures to ensure the identity, purity, strength, and composition of dietary supplements. They mandate compliance with education, training, and experience requirements for quality control personnel and supervisors.


Failure to comply with the regulations is deemed "adulteration" without need for proof that products present an actual risk of illness or injury to the public.

The FDA is implementing these regulations in a tiered fashion, requiring companies of 500 employees or more to come into compliance in July of 2008, of between 20 and 499 employees to come into compliance in July of 2009, and of between 1 and 20 employees to come into compliance in July of 2010. Whether your company manufactures, holds, or distributes dietary supplements, early achievement of compliance is well-advised.


Get Informed about cGMP and Your Compliance


  1. Emord & Associates held a three-hour teleconference one business day after adoption of the rules.  You may obtain a copy of the three-hour conference on CD from the firm by calling 202-466-6937.
  2. Emord & Associates has created a Compliance Kit, including detailed checklists, for your use in achieving compliance with the new cGMPs.  You may obtain a copy of the Compliance Kit from the firm by calling 202-466-6937.
  3. Emord & Associates offers on-site audits to evaluate compliance and assist in modifying operations to ensure compliance.  You may schedule an on-site audit from the firm by calling 202-466-6937.
  4. Emord & Associates conducted a one-hour teleconference concerning FDA cGMP inspections.  You may obtain a copy of the one-hour teleconference by contacting the firm at 202-699-6937.