The U.S. Food & Drug Administration (FDA) has issued an Import Alert updating its guidelines for imported food products that appear to be misbranded. The FDA can detain food imports if the packaging appears to be misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The charge can be applied to the following scenarios:
False or misleading labeling
Label does not display the name and place of business of the manufacturer, packer, or distributor
The weight, measure, or quantity of the product is inaccurately displayed on the label
The label is not prominently displayed in a manner that is easily readable and understandable.
The label contains information in two or more languages but not all information is repeated in all languages.
The label doesn’t include the common or usual name of the food.
The label doesn’t accurately display or describe all the ingredients in the product and their percentages
If the food contains chemical preservatives or artificial flavorings, the label does not state that fact and their functions
The label is missing required nutrition information
The label makes false nutrition and/or health claims
Dietary supplements are not accurately identified
To secure release of a shipment detained pursuant to this Import Alert, the importer should provide all relevant information supporting the request for release to the appropriate FDA Division compliance office.
The U.S. Food and Drug Administration (FDA) has announced that it will delay enforcing the new requirements for registering and listing cosmetics products for six months to make the transition easier for the industry.
MoCRA is the most significant expansion of the FDA’s cosmetics regulation efforts since the Federal Food, Drug, and Cosmetic Act of 1938. It gives the FDA new authority to access and copy certain records related to cosmetic products if certain conditions are met, and the authority to issue mandatory recalls on products if they violate health and safety standards.
MoCRA also establishes new requirements for the industry:
Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
Product Listing: A “responsible person” (the manufacturer, packer, or distributor) must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Adverse Event Reporting: A responsible person is required to report serious adverse events (such as hospitalization) associated with the use of cosmetic products in the United States to the FDA within 15 business days
Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.
The requirements will apply to the following cosmetics categories:
Baby products, including shampoo, lotion, oil, creams, and baby wipes
Bath products, including bubble bath, bath oils, tablets, and salts
Eye makeup, including eyebrow pencils, eye shadow, and mascara
Childrens’ eye makeup
Fragrances, including perfume and cologne
Hair preparations, including conditioner, hair spray, and shampoo
Hair coloring preparations, including hair dye, tints, and coloring rinses
Non-eye makeup, including blush and rouge, face powder, foundation, and lipstick
Children’s makeup (non-eye), including face paint and lip gloss
Manicuring preparations, including nail polish, nail extenders, and cuticle softeners
Oral products, including mouthwash and toothpaste
Personal cleanliness products, including deodorant, soap, and body wash
Shaving preparations, including shaving cream and aftershave
Skin care preparations, including creams, lotions, powders, and sprays
Suntan lotions, creams, gels, etc.
Tattoo preparations, including permanent and temporary tattoo ink
FDA hosted a webinar that provides an overview of the Modernization of Cosmetics Regulation Act of 2022 and outlines the requirements mandated by the act and the current steps FDA is taking to implement the requirements, including an update on the Voluntary Cosmetic Reporting Program, and information about a public listening session on good manufacturing practices (GMPs).
The Food and Drug Administration (FDA) has ended its policy of enforcement discretion for foreign food facilities, This had previously provided the option to select “pending” for food facility registrations.
The FDA is now beginning to cancel registrations and block imports of food from facilities that have not provided a Unique Facility Identifier (UFI).
The FDA requires facilities to provide a UFI recognized as acceptable by the FDA. Currently, the FDA recognizes the Data Universal Numbering System (DUNS) as acceptable. In October, 2020, the FDA announced that it would provide the option to select the “Pending UFI Option” for food facility registrations to allow sufficient time for registrants to obtain a DUNS number. That time has now arrived.
If a foreign food facility is not registered with a recognized UFI, the food being imported or offered for import into the US from the foreign facility may be held at the port of entry until the foreign facility is registered appropriately.
