FDA will be holding a webinar on the new FDPB on October 10, 2019 at 1 pm eastern time. Register here.
FDA Issues Proposed Rule for Premarket Tobacco Product Applications for E-Cigs
FDA has issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.
Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The agency’s evaluation also includes reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled.
USDA Restricts PACA Violators in Georgia and Pennsylvania
Harvest Soul LLC, operating out of Fairburn, Ga., for failing to pay a $5,492 award in favor of a Florida seller. As of the issuance date of the reparation order, Kevin Quirk was listed as a member of the business.
Church Hill Farms and Logistics, operating out of York, Pa., for failing to pay a $1,063,529 award in favor of a California seller. As of the issuance date of the reparation order, Vincenzo F. Giuffrida was listed as the officer, director and major stockholder of the business.
APHIS Releases Pest Risk Assessment for Sand Pears and Import Evaluation Document for Unshu Oranges from Japan
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has prepared and is accepting comments on a pest risk analysis regarding the importation of fresh sand pear fruit from Japan into the United States. After thorough analysis, APHIS scientists have determined that sand pears from all areas of Japan, excluding Amami, Bonin, Ryukyu, Tokara, and Volcano Islands, can be safely imported under the current import requirements. At this time, sand pears may only be imported from certain authorized production areas within Japan.
APHIS has also prepared and is accepting comments on a commodity import evaluation document (CIED) regarding fresh Unshu orange imports from Japan. Based on their findings, they are proposing to remove the methyl bromide fumigation requirement for imports of oranges from the islands of Shikoku and Honshu. Currently, oranges from these islands destined for ports of entry in Arizona, California, Florida, Hawaii, Louisiana, and Texas must be fumigated with methyl bromide to mitigate mites and mealybugs. Additionally, they are proposing that oranges from the island of Kyushu—which are currently prohibited from entering ports of entry in Arizona, California, Florida, Hawaii, Louisiana, and Texas—be allowed entry into any U.S. port of entry, excluding territories.
APHIS has added the following countries to the list of regions affected by African Swine Fever:
FDA Approves New Packaging for OTC Loperamide to Curb Abuse
FDA announced Sept. 20, approved package size and package type limits for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide, an FDA-approved drug product that helps control symptoms of diarrhea, including Travelers’ diarrhea. The changes to Imodium A-D, Imodium Multi-Symptom Relief and Be Health Loperamide HCl Capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging.
The maximum approved daily dose of OTC loperamide for adults is 8 milligrams per day and 16 milligrams per day for prescription use. While loperamide is safe at approved doses, the FDA has received reports of serious heart problems and deaths associated with loperamide, and the majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide. More information here.
FDA Launches Food Safety Initiative for Yuma Leafy Greens
FDA has launched a new initiative with support from the Arizona Department of Agriculture, and in conjunction with the University of Arizona Cooperative Extension, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry to better understand the ecology of human pathogens in the environment in the Yuma agricultural region. This initiative will be a multi-year study which will focus on how these pathogens survive, move and possibly contaminate produce prior to harvest.
The launch of this initiative follows the largest E.coli O157:H7 outbreak in the United States since 2006. The outbreak, which was linked to romaine lettuce grown in the Yuma region, began in the spring of 2018 and resulted in 210 reported illnesses from 36 states, 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.
FSIS Releases Updated Directive on Responding to Elevated Public Health Regulation Noncompliance Rates
The directive summarizes how FSIS determines the annual updated list of Public Health Regulations (PHRs). Based on FSIS data analysis, PHRs are associated with positive pathogen results or enforcement actions. PHR noncompliance rate data are used to inform FSIS as to when additional evaluation is necessary to assess an establishment’s operational and compliance history. This directive also instructs in-plant FSIS inspection program personnel (IPP) and Frontline Supervisors (FLSs) on how to respond to the Public Health Information System (PHIS) Early Warning Alerts. Finally, this directive provides information on when the District Office (DO) is to schedule a Public Health Risk Evaluation (PHRE) to determine if a Food Safety Assessment (FSA) is necessary.
U.S. Signs Trade Agreement with Japan
The agreement reduces tariffs on beef, pork, persimmons, green tea, chewing gum and soy sauce imports from Japan among other products.
FDA Commissioner Testifies on Vaping Illnesses
On Sept. 25, Acting FDA Commissioner Ned Sharpless testified before the House Energy and Commerce Committee on vaping illnesses.
APHIS Issues FAQ Document to Answer Questions about Federal Order for the Importation of Tomato and Pepper Seeds
Disclaimer: This material is provided as a service to clients and friends of U.S. Food Imports LLC and does not constitute legal advice. As legal advice must be tailored to the specific circumstances of each case and laws and regulations are frequently changing, nothing provided herein should be used as a substitute for the advice of competent counsel.