The Food and Drug Administration has issued a warning letter to BNB Medical Co., Ltd. of Seoul, Korea regarding its manufacturing and marketing of BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair Removal devices without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act, and are subject to refusal of admission under the FFDCA. FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.
The Office of Management and Budget has approved a Food and Drug Administration interim final rule entitled: Administrative Detention of Food for Human or Animal Consumption. The need for this rule is based on a statutory deadline.
Food and Drug Administration sources have informed Broker Power that the agency expects to deploy PREDICT1 to its Atlanta and Minneapolis Districts soon, and training is underway for users in those districts. The agency recently successfully deployed PREDICT to the Florida and San Juan Districts.
On April 27, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On April 25, 2011, the Environmental Protection Agency and the Department of Energy released a draft guidance outlining the sample size approach to new verification testing programs for DOE and third-party certification bodies in support of the ENERGY STAR program, and how the approach relates to determining testing failures.
The Food and Drug Administration has issued a warning letter to Lifetech Resources LLC regarding its manufacturing, distribution, and promotion of RapidLash Eyelash Renewal Serum, NeuLash Active Eyelash Technology, and NeuveauBrow Active Eyebrow Technology, which FDA states are unapproved and misbranded drugs and violate provisions of the Federal Food, Drug, and Cosmetic Act. FDA urges LifeTech to take prompt action to correct the violations, and states that failure to promptly correct the violations may result in legal action, including seizure and injunction.
On April 26, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency is announcing a new category of commercial fryers that can now earn the ENERGY STAR label. Effective April 22, 2011, EPA expanded the scope of the eligible models to include large vat gas and electric fryers. ENERGY STAR qualified large vat fryers are 10-35% more energy efficient than standard models. More information on commercial fryers is available here.
The Food and Drug Administration is requesting comments by June 27, 2011, to help it review its framework for analyzing existing regulations to determine whether they should be modified, streamlined, expanded, or repealed, pursuant to Executive Order 13563, "Improving Regulation and Regulatory Review1."
On April 22, 2011, the Food and Drug Administration updated Import Alert #99-33 on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination. The update affects milk, kakina, and spinach from the Ibaraki prefecture and sand lance (a type of fish also known as sand eels) from the Fukushima prefecture. It also updates the product codes subject to the import alert.