FDA Issues MedWatch Safety Alert for Vaping Products
The U.S. Food and Drug Administration (FDA) has issued a MedWatch Safety Alert to consumers entitled Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses.
Many of the samples tested by the states or by the FDA as part of its ongoing investigation into vaping illnesses have been identified as vaping products containing tetrahydrocannabinol (or THC, a psychoactive component of the marijuana plant) and further, most of those samples with THC tested also contained significant amounts of Vitamin E acetate. Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.
While the FDA does not have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury in these cases, the agency believes it is prudent to avoid inhaling this substance. Because consumers cannot be sure whether any THC vaping products may contain Vitamin E acetate, consumers are urged to avoid buying vaping products from the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores. Additionally, no youth should be using any vaping product, regardless of the substance.
Trump Administration Moves to Ban Flavored E-Cigarettes
The Trump Administration has announced that as part of its ongoing work to tackle the epidemic of youth e-cigarette use, the FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon.
FDA Warns JUUL Labs for Marketing Unauthorized Modified Risk Tobacco Products, Including Outreach to Youth
FDA announced that it has issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. The agency indicated that these actions are part of an ongoing investigation.
FSIS Tips For Label Approval
In its latest consituent update, the Food Safety and Inspection Service (FSIS) published the following tip for label approval:
Submitting only the necessary supporting documentation with your label application will decrease the time it takes you to prepare and submit your label application as well as the time it takes the FSIS to evaluate the label.
Any documentation submitted with a label application must be evaluated by FSIS as part of the label approval process. Establishments often include extraneous documentation with their label application resulting in unnecessary delays. For example, a label application for an “Organic Beef Burrito” product would not need to include a copy of the incoming label for each ingredient used to formulate the product to support that the product is certified Organic. A current Organic certificate would suffice as support for the organic claim for the entire product. Additional examples of unnecessary documentation are copies of an establishment’s Grant of Inspection and laboratory results of allergen testing on the finished product when the product does not contain those specific allergens.
FSIS Meets Targets in National Antimicrobial Resistance Monitoring System Sampling Program for Young Chickens and Market Swine
FSIS collects samples for the National Antimicrobial Monitoring System (NARMS) sampling program under directive FSIS Directive 10,100.1, FSIS Sampling for the National Antimicrobial Monitoring System. This data is used to monitor for trends in antimicrobial resistance and susceptibility among enteric bacteria in food animals on a yearly basis. FSIS has reached its sampling targets for the young chicken and market swine projects for CY 2019 and will no longer sample these product groups.
FSIS Updates List of U.S. Establishments Eligible to Export to Mexico
FSIS Updates List of Establishments From Argentina Eligible to Export to the U.S.
FDA Announces Cooperative Agreement to Implement Produce Safety Rule
FDA has announced a cooperative agreement to provide funding that will allow The National Association of State Departments of Agriculture (NASDA) to assist state and territorial produce safety regulatory programs in developing produce safety programs that encourage the safe production of fresh fruits and vegetables, understanding of the Produce Safety Rule, and compliance with the Produce Safety Rule’s requirements.
StarKist Ordered to Pay $100 Million for Tuna Price Fixing
StarKist Co. was sentenced to pay a criminal fine of $100 million, the statutory maximum, for its role in a conspiracy to fix prices for canned tuna sold in the United States. StarKist was also sentenced to a 13-month term of probation. StarKist was sentenced for its participation in a conspiracy to fix the prices of canned tuna fish from as early as November 2011 through at least as late as December 2013. As part of the sentencing hearing, U.S. District Judge Edward M. Chen found that StarKist had not proven that its financial circumstances justified a lower criminal fine. The Department of Justice Antitrust Division opposed StarKist’s request for a fine reduction, arguing that StarKist had sufficient financial resources to pay a $100 million criminal fine. In addition to the criminal fine and term of probation, StarKist has also agreed to cooperate in the Antitrust Division’s ongoing investigation. More information may be found here.
Latest FDA Warning Letters
The latest FDA warning letters are:
Please contact Erik Lieberman at elieberman@usfoodimports.com or (202) 765-1800 if you have questions or would like additional information. |