The Food and Drug Administration announced the availability of a draft guidance on medical product labeling related to latex content. FDA said it issued the guidance because manufacturers have included terms like “latex-free” or “does not contain latex” on medical product labeling, but such statements are not specific enough, not scientifically accurate, and should not be included in medical product labeling, the agency said. The guidance recommends accurate labeling that can be used by manufacturers that which to convey no natural rubber was used in a product. Comments on the guidance are due by June 10.
On March 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 6 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration said a guidance is available on administrative detention of food. The FDA updated a previous guidance to make it consistent with a recent final rule on administrative detention regulations. Under the final rule, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. Decisions on whether FDA has a “reason to believe” a food is adulterated or misbranded are made on a case-by- case basis because such decisions are fact specific. The guidance is here.
The Food and Drug Administration is making technical amendments to its regulations on food and color additives. Changes include corrected misspellings of chemical names, a corrected table entry on the melting point of some nylon 2T resins, and amendments to several provisions to update office names and street addresses. The changes are effective March 7.
On March 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Feb. 25 - March 3, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
The Food and Drug Administration debarred Adrian Vela from importing food or offering food for importation into the U.S. for five years. Vela was convicted in November 2011 in Southern Florida District Court for conspiracy to falsely label and misbrand food, one count of false labeling of seafood under the Lacey Act, and one count of misbranding food, FDA said. In 2008 and 2009, Vela imported shrimp from Thailand, Malaysia, and Indonesia, but directed a Tampa facility to repack and relabel the shrimp as a product of Panama in order to make it more readily marketable. The relabeled shrimp were then sold to a wholesaler in Keene, N.H., which in turn sold the shrimp to a supermarket chain headquartered in Landover, Md., FDA said (presumably the mid-Atlantic chain Giant Foods).
The Food and Drug Administration issued orders granting exemptions for premarket notification requirements for stairway chair lift (here) and inclined/vertical platform lift devices (here), subject to certain conditions. Effective March 4, these devices may be distributed without a letter of substantial equivalence from FDA. Conditions for the exemption include appropriate analysis and testing and restraints to prevent the user from falling.
During the week of Feb. 18-24, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: