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 […]
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 […]
As reported in an article from FoodNavigator-USA.com, the Food and Drug Administration (“FDA”) responded to ConAgra Foods Inc.’s petition for a qualified health claim for whole grains and reduced risk of diabetes mellitus type 2. ConAgra’s petition proposed that the following two model health claims be allowed on the labels or in the labeling of […]
The Food and Drug Administration (“FDA”) is enforcing its draft medical foods guidance. As previously reported here, FDA published a draft medical food guidance last month that severely restricts the type of products that qualify as medical foods. The draft guidance states that a food is a “medical food” only if: – It is a […]
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 We previously reported on that draft guidance document here.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 […]
On August 13th, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance on medical foods entitled, “Draft Guidance for Industry: Frequently Asked Questions About Medical Foods, Second Edition.” FDA issued the draft guidance in response to confusion over the definition, labeling, and availability of medical foods, and to update FDA’s […]
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 […]
Consumers harmed by a generic drug manufacturer’s failure to warn have no recourse thanks to a U.S. Supreme Court ruling. In 2004, Karen Bartlett took sulindac, a generic, prescription-only non-steroidal anti-inflammatory drug manufactured by Mutual Pharmaceutical, for her painful shoulder. A few weeks after Bartlett took the drug, she developed an acute case of toxic […]
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