Emord & Associates, P.C. is pleased to announce that effective December 2013 the firm expanded its state level practice to include direct representation of clients in the state courts of California and before California regulatory agencies. The firm now directly represents clients in matters concerning California Proposition 65, California unfair competition claims (UCL), claims under […]
On September 10, 2013, FDA published a new guidance document restricting the scope of research permitted for dietary supplements and medical foods without first submitting an Investigational New Drug application (“IND”). The document titled, “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted […]
The FDA’s revised Medical Food guidance turned heads last week when the agency declared that certain diseases related to nutrient deficiencies were off limits to medical foods. We previously reported on that draft guidance document here. By eliminating an entire class of diseases from the ambit of medical foods, the FDA left many existing products […]
In July the FDA proposed two rules under the Food Safety Modernization Act (FSMA). One rule concerns Foreign Supplier Verification Programs (FSVP). The other concerns Accreditation of Third Party Auditors. Under the FSVP rule, FDA plans to have importers verify that their suppliers meet the same U.S. safety standards required of domestic food producers. The […]
USNewswire–CLIFTON, VA (Aug. 8, 2013)–Martindale-Hubbell, a division of LexisNexis®, has confirmed that attorney Jonathan W. Emord still maintains the AV Preeminent Rating, Martindale-Hubbell’s highest possible rating for both ethical standards and legal ability, even after first achieving this rating in 1996. Please join us in congratulating Jonathan on this achievement.
Qualified Health Claims permit nutrient-disease risk reduction claims to be made for dietary supplements without fear of FDA or FTC enforcement. The FDA allows such claims in reliance on its “enforcement discretion,” following submission of a health claim petition. The FDA’s “enforcement discretion” is a euphemism because the agency is constitutionally barred by precedent in […]
Emord & Associates has published an FDA Inspection Guide to help food and dietary supplement companies avoid common pitfalls associated with FDA inspections. The guide, available for download online here, covers routine, cGMP, FSMA, and adulteration inspections. It identifies the kinds of documents FDA ordinarily can and cannot obtain lawfully. The guide provides general information […]
On April 5, 2013, the Alliance for Natural Health USA (ANH) and Certified Board for Nutrition Specialists (CBNS) each filed comments opposing a Medicare reform regulation proposed by the Centers for Medicare & Medicaid Services (CMS). CMS proposed regulatory revisions to promote program efficiency, transparency, and burden reduction. See 78 Fed. Reg. 9216-01 (Feb. 2013). […]
On April 4, 2013, AbleChild.org filed an appeal with the Connecticut Freedom of Information Commission (FOIC) seeking release of Adam Lanza’s medical records held by the Connecticut Medical Examiner’s Office. That appeal, prepared by Emord & Associates and filed by the Heitke Law Office (Rhode Island), contests the Connecticut Medical Examiner’s refusal to disclose the […]
Foreign pharmaceuticals, active pharmaceutical ingredients (APIs), and other regulated drug products are more accessible than ever before. The internet fosters direct transactions between consumers and foreign retailers. Many physicians and practitioners purchase products from foreign sources in their routine practice. But certain drug products may not be “approved” for sale in the United States market. […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
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