New requirements for cosmetics companies to submit facility registrations and product listings will be implemented July 1. These requirements cover a broad range of items such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.
Under the Modernization of Cosmetics Regulation Act of 2022, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually.
There are exemptions to these requirements for certain small businesses as well as certain products and facilities that are subject to requirements for drugs and medical devices.
In addition, the FDA does not intend to enforce the facility registration and product listing requirements until July 1. This deadline applies to all facility registrations and product listings, regardless of when the facilities first engaged in manufacturing or processing or when the products were first marketed.
Click here for more information and assistance on registering your cosmetic facility or product.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>A Philadelphia-area man was sentenced to 12 months in prison and one year of supervised release for his role in distributing medical devices without U.S. Food and Drug Administration clearance. A regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act by causing the introduction of misbranded and adulterated medical devices into interstate commerce. He admitted that in 2017, he created two false letters that purported to show that FDA had granted clearance to sell two different medical devices. As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>Under the Modernization Of Cosmetics Regulation Act of 2022, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually. There are exemptions to these requirement for certain small businesses as well as certain products and facilities that are subject to requirements for drugs and medical devices.
The FDA can suspend a facility’s registration if it determines that a cosmetic product manufactured or processed by that facility and distributed in the U.S. has a reasonable probability of causing serious adverse health consequences or death to humans and it has a reasonable belief that other products manufactured or processed by that facility may be similarly affected because of a failure that cannot be isolated to a product or products or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the U.S. cosmetic products from that facility.
However, the FDA announced recently that it does not intend to enforce the facility registration and product listing requirements until July 1, 2024. This deadline applies to all facility registrations and product listings, regardless of when the facilities first engaged in manufacturing or processing or when the products were first marketed.
The FDA’s final guidance explains these requirements, what key terms mean, who is responsible for making submissions, what information to include in submissions, and how and when to make submissions. It also contains information about a new electronic submission portal (though the FDA is also developing paper forms – FDA 5066 and 5067 – and expects them to be available soon).
The FDA notes that changes from a draft guidance issued earlier this year include additional information on the facility registration number, U.S. agent, and electronic and paper submissions, as well as a new section of frequently-asked questions and answers.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>Under the Modernization of Cosmetics Regulation Act of 2022, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually.
There are exemptions to these requirement for certain small businesses as well as certain products and facilities that are subject to requirements for drugs and medical devices.
The FDA’s new guidance states that the agency does not intend to enforce the facility registration and product listing requirements until July 1, 2024. This deadline applies to all facility registrations and product listings, regardless of when the facilities first engaged in manufacturing or processing or when the products were first marketed. (The FDA had previously set variable deadlines based on these events that began as early as Dec. 29, 2023.)
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>The FDA uses prior notice information to determine which products should be inspected upon arrival in the U.S. The agency is now proposing to make the following changes to its prior notice regulations.
- add a requirement that prior notice information be submitted within 10 calendar days, and food facility registration information be submitted within 30 calendar days, from the date a notice of refusal or hold was issued (this change could reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges)
- add a requirement for people submitting prior notice for articles of food arriving by international mail to provide the name of the mail service and the mail tracking number (to enable the FDA to better coordinate with U.S. Customs and Border Protection and the U.S. Postal Service to track and inspect articles identified as a possible bioterrorism risk)
- remove the requirement that prior notice of goods arriving by international mail be submitted through the FDA’s Prior Notice Systems Interface and instead allow such notice to be submitted via PNSI or the Automated Broker Interface/Automated Commercial Environment/International Trade Data System
For more information on this proposal, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>- The existence of a systems recognition arrangement with or an equivalence determination of a foreign country does not exempt foods imported from that country from FDA prior notice requirements.
- Notification of prior notice refusals and holds will be communicated to U.S. Customs and Border Protection and provided to the relevant party (i.e., the submitter or transmitter of prior notice) upon arrival of the article (because advance notice could create incentives for bad actors who may attempt to reroute their entries to evade FDA requirements and import unsafe food).
- The five calendar day period within which certain parties may request reviews of prior notice refusals and holds begins when the FDA provides notice of the refusal or hold to the submitter or transmitter.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
Failure to submit, renew, update, or cancel a registration can result in civil or criminal action as well as import restrictions.
Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during this year’s renewal period, please contact Domenic Veneziano at (202) 734-393.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
Failure to submit, renew, update, or cancel a registration can result in civil or criminal action as well as import restrictions.
Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opens Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.
]]>The Food and Drug Administration has issued a draft guidance to assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the agency. The guidance covers a broad range of items such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.
The guidance describes the Modernization of Cosmetics Regulation Act of 2022’s requirements for facility registration and product listing as well as the exemptions for certain small businesses. Under MoCRA, every person that as of Dec. 29, 2022, owned or operated a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register each facility no later than Dec. 29, 2023. Every person that owns or operates a facility that first engaged, after Dec. 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the U.S. must register such facility within 60 days of first engaging in such activity or by Feb. 27, 2024, whichever is later.
With regard to product listings, under MoCRA the responsible person of a cosmetic product marketed as of Dec. 29, 2022, must submit a cosmetic product listing no later than Dec. 29, 2023, or for a cosmetic product that is first marketed after Dec. 29, 2022, within 120 days of marketing such product in interstate commerce. Consistent with the approach for registration of a facility that starts manufacturing or processing cosmetic products after Dec. 29, 2022, the FDA expects the product listing for a cosmetic product first marketed after Dec 29, 2022, to be submitted within 120 days of marketing the product, or within 120 days of Dec. 29, 2023, whichever is later.
Facility registration information is to be updated within 60 days of a change and registration to be renewed every two years. Additionally, any updates to a product listing, such as a change in product ingredients, are to be provided annually.
Comments on the draft guidance may be submitted through Sept. 7. For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on August 9, 2023.
]]>For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on August 2, 2023.
]]>Foreign and domestic facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must obtain and submit a unique facility identifier with their registration submissions. The requirement to include a UFI applies to both new facilities registering for the first time and those submitting a registration renewal.
The FDA currently recognizes only the DUNS number as an acceptable UFI for food facility registration. Because a DUNS number has been difficult for some to obtain, the FDA had allowed registrants to enter “PENDING” in the UFI field of their registration if they had not obtained one.
However, apparently having determined that there has been sufficient time for facilities to obtain a DUNS number, effective March 10 the FDA started notifying foreign and domestic facilities that food facility registrations without an accurate UFI will be canceled.
As a result, the FDA will no longer confirm registrations or provide facilities with a registration number until it verifies the accuracy of their facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with the registration.
If the FDA determines that a foreign food facility is not registered, the food being imported or offered for import into the U.S. from that facility is subject to being held at the port of entry unless U.S. Customs Border Protection concurrence is obtained for the export and the food is immediately exported from the port of arrival. Food held in this circumstance must not be entered and must not be delivered to the importer, owner, or ultimate consignee until the foreign facility is registered appropriately. The FDA ordinarily will not allow the food to be transferred by any person from the port of entry into the U.S. or from the secure facility.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on March 29, 2023.
]]>Foreign and domestic food and medical device facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for both types of facilities are due this year.
Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
In addition, owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
For food facilities, failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action. Similar consequences exist for medical device registrations.
Foreign and domestic food and medical device facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. However, to ensure your company is registered during the renewal period this year, please register or renew via FDA Solutions Group by Dec. 15.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on December 14, 2022.
]]>Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
In addition, owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
For food facilities, failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action. Similar consequences exist for medical device registrations.
Foreign and domestic food and medical device facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
The Federal Food, Drug, and Cosmetic Act requires the FDA to refuse admission into the U.S. of a food from a foreign food establishment of which the owner, operator, or agent in charge, or the foreign government, refuses to permit an inspection. As a result, foreign food establishments that have refused an FDA inspection will be identified on the “Red List” of Import Alert 99-32 and food offered by such establishments for entry into the U.S. will be refused admission.
According to the new guidance, the FDA considers inspection refusals to include statements, actions, and passive behaviors that (1) prevent or delay it from scheduling or fully conducting an inspection or (2) are intended to avoid inspection or to mislead or deceive FDA investigators in a manner that prevents them from conducting the inspection. The guidance provides examples of situations the FDA may consider to be a refusal, though these examples are not intended to serve as an exhaustive list.
This guidance finalizes a draft version issued in December 2017 with several changes, including providing additional information on the FDA’s inspection authority; clarifying that the investigator will inform the owner, operator, or agent in charge of the establishment when they consider their action to be a refusal and will explain the consequences of the refusal; and clarifying that the FDA will make the final decision regarding refusal and listing on Import Alert 99-32.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 26, 2022..
]]>Foreign and domestic medical device facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for such facilities are due each year.
Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
Failure to submit, renew, update, or cancel a registration can result in civil or criminal action as well as import restrictions.
Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 20, 2022.
]]>Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
Failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action.
Foreign and domestic food facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 4, 2022.
]]>Foreign and domestic food facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for these registrations are due by the end of 2022.
Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
Failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action.
Foreign and domestic food facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on September 21, 2022.
]]>VQIP is a voluntary fee-based program that provides faster review and importation of human and animal foods for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign suppliers are certified under the accredited third-party certification program.
Qualified importers must submit a notice of intent to participate and a completed application. Notices of intent must be resubmitted each year. Once approved, importers must pay an annual fee.
Preparing and submitting VQIP applications can be a time-consuming process. Importers must have at least a three-year history of importing food into the U.S. and be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Program and the juice and/or seafood Hazard Analysis and Critical Control Points regulations, if required. However, VQIP requires that importers go one step further to establish additional controls over their supply chains; e.g., creating quality assurance programs, which include written policies and procedures regarding safety and security and show compliance with criteria related to transportation and food defense.
For more information on, or assistance with, the VQIP application process, please contact FDA consultant Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on May 11, 2022.
]]>Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
Failure to submit, renew, update, or cancel a registration can result in civil or criminal action as well as import restrictions.
Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 20, 2021.
]]>The Food and Drug Administration is accepting comments through Sept. 10 on a draft guidance on the FDA’s regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in systems recognition arrangements.
An SRA establishes a regulatory partnership between the FDA and its regulatory counterpart in an exporting country when each side has concluded that the other has (1) a food safety system that provides a similar, though not necessarily identical, system of protections as its own and (2) a food safety authority or authorities that provide similar oversight and monitoring activities for food produced under its jurisdiction. To date the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.
For food products covered by an SRA and imported from a country with an active SRA, the FDA intends to adjust its regulatory oversight activities as follows.
- Routine inspections of foreign food establishments for such foods will be rare and import samples and field exams of food products covered by an SRA will not be prioritized. However, inspections and sampling will be conducted for foods not covered by the SRA or when necessary to address specific food safety issues or public health concerns.
- The FDA will not generally prioritize inspections of importers for Foreign Supplier Verification Program compliance or compliance with juice and seafood Hazard Analysis and Critical Control Point importer requirements with respect to imported foods covered by an SRA.
- Risk-based screening and targeting criteria for imports of food products covered by an SRA will be adjusted to reflect the FDA’s comparability determination.
- Food products and establishments subject to detention without physical examination under an existing import alert will not be automatically removed from the alert when an SRA is signed.
- The FDA may pursue regulatory actions such as warning letters, import alerts, and refusing imports when food covered by an SRA that appears violative is offered for import into the U.S. and/or intended for use in the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on July 21, 2021.
]]>At this time, the FDA recognizes the DUNS number as an acceptable UFI for food facility registration. However, because a DUNS number has remained difficult for some to obtain, the FDA is allowing registrants until the end of the next registration cycle to submit a DUNS number as part of the UFI requirement. During this time the FDA intends to continue to allow registrants to enter “PENDING” in the UFI field of their registration if they have not obtained a DUNS number. The FDA also does not intend to cancel any registrations for facilities with UFIs that cannot be verified at this time.
For more information on this and other FDA issues, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 7, 2022.
]]>The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.
Violations. Most recently, FDA inspections of the facilities of three importers found that they failed to do one or more of the following respect to imported tamarind paste, roasted foxnuts, mango pulp, curried mustard leaves, chocolate bar, chocolate dairy mix, botanas puffed snack, guava paste, coconut water with pulp, and frozen yellow pepper dices.
- develop, maintain, and follow an FSVP
- verify and document that thermally-processed low-acid foods packaged in hermetically-sealed containers were produced in accordance with applicable requirements
- provide documentation that the foreign supplier’s hazard analysis was reviewed and assessed
- approve foreign suppliers on the basis of an evaluation of their performance and the risk posed by the food
- establish and follow written procedures to ensure only foods from approved foreign suppliers are imported
- establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted
- conduct and document one or more supplier verification activities before importing the food
The FDA states that within 15 working days these importers should provide information on the specific things they are doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importers do not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting them to detention without physical examination.
Guidance. In relation to these violations, the FDA notes that one of the importers did not maintain its own records of its imported foods and instead only requested documents as needed from its foreign suppliers but did not review those documents.
The FDA also points out that the foreign supplier for purposes of the FSVP regulation might not be the entity from which the importer directly obtains the food. If food is obtained from a foreign warehouse, distributor, broker, or other entity that does not perform any manufacturing or processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing or processing. Importers are responsible for evaluating and approving such foreign suppliers and determining and conducting appropriate verification activities.
For more information on these and other FDA issues, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on February 24, 2021.
]]>Foreign and domestic food facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for these registrations are due this month.
Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
Failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action.
Foreign and domestic food facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on December 15, 2020.
]]>Foreign and domestic food and medical device facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for both types of facilities are due this year.
Under the Food Safety Modernization Act, all foreign and domestic facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registrations with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided this confirmation.
In addition, owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.
For food facilities, failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action. Similar consequences exist for medical device registrations.
Foreign and domestic food and medical device facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.
FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during the renewal period this year, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 7, 2020.
]]>Most recently, FDA inspections of the facilities of two importers found that they did not develop, maintain, and follow the required plans for mushroom soup powder, seasoning sauce with garlic and chili, roasted corn, puffed rice, kalizera rice, and flattened rice.
In each case, the FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting them to detention without physical examination.
For more information, please contact Domenic Veneziano at (202) 734-3939.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on September 23, 2020.
]]>The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program. The FSVP requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.
In the latest case, two FDA inspections of an importer’s facility found that the importer did not develop, maintain, and follow the required plans for strawberry filling, pineapple filling, and multicolor sprinkles manufactured in Mexico. The FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of the violative products and subjecting them to detention without physical examination.
FDA import alerts on the following have been modified in the past week.
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 22, 2020.
]]>Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 15, 2020.
]]>Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 8, 2020.
]]>Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 1, 2020.
]]>The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program. The FSVP requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.
In the latest case, two FDA inspections of the importer’s facility found that the importer did not have the required plans for fried onions, basmati rice, and other products. The FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of the violative products and subjecting them to detention without physical examination.
Import Alerts on Foods, Drugs, and Medical Devices That May be Detained
Food and Drug Administration import alerts on the following have been modified in the past week.
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on March 25, 2020.
]]>