In a recent article appearing on NutraIngredients-USA.com, Emord & Associates’ associate Bethany R. Kennedy comments on new dietary ingredient notifications for products that are approved drugs outside of the U.S. Click below to read the full text of the article at NutraIngredients-USA.com. Hank Schultz, “Companies must walk fine line when bringing a supplement to market […]
In a recent article appearing in Foodnavigator-USA.com, Emord & Associates’ principal Peter A. Arhangelsky predicts that a broad decision from the Supreme Court this year could limit food and dietary supplement manufacturers’ exposure to consumer suits in plaintiff-friendly states like California. To get there, however, the Court must hold that the FDA is the exclusive […]
Representative Mike Pompeo (R-KS) introduced legislation last Wednesday that would preempt state laws that require mandatory labeling of genetically modified foods. Currently, Maine and Connecticut have passed GMO labeling laws that are contingent upon other states approving such laws, but many other states are considering enacting GMO labeling laws. Pompeo’s bill, named the Safe and […]
Emord & Associates, P.C. is an AV-rated (highest in legal ability and ethics, Martindale-Hubbell organization) constitutional and administrative law firm located in Washington, D.C., Clifton, Virginia, and Chandler, Arizona (see emord.com). The firm has represented clients in eight successful First Amendment challenges against the Food and Drug Administration since 1999. On January 22, 2014, Emord […]
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 We previously reported on that draft guidance document here.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 […]
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 […]
As previously reported here, in the prior administration, FDA had an unwritten and informal enforcement policy that that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. […]
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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