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Video segment from December 8, 2020 LawCustoms Stream discussing new regulatory requirements for FDA’s Biennial Registration. Full playback of December 8, 2020 LawCustoms Stream is available here. Links Relied Upon During the Presentation https://www.fdadunslookup.com/FDA%20DUNS%20Portal%20User%20Guide.pdf
Read More D&B Becomes Part of FDA’s Biennial Submission (LawCustoms Stream Excerpt)
News for low value ($800 or less) importers of: Cosmetics; Dinnerware (including eating and/or cooking utensils); Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.); Biological samples for laboratory testing; Food, excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in air tight containers intended to be stored at room temperature. Pursuant to CSMS #17-000388, “a release may be issued without notification to FDA for the purposes of determining entry admissibility under section 801(a) of the Federal Food, Drug & Cosmetic Act (the Act), if the shipment is valued at or below the current de minimis level (currently $800).” Sec. 801(a) submission (21 U.S.C. § 381(a)), previously made via FDA Form 701 (CSMS #94-001260), and currently made via CBP Forms 3461/3461ALT/7501 where information is forwarded to FDA through CBP’s Automated Commercial Environment (ACE), provides for examination or sampling of an article offered for import. This does not mean, however, that $800 or less food shipments are exempt from prior notice (21 U.S.C. § 381(m)) requirements by virtue of its low value. Low value is not a factor. But! Prior notice exemption factors – 21 C.F.R. § 1.277 – are: Food for an individual’s personal use…
Keeping with spirit of open government and that people deserve to know, Food and Drug Administration took an additional measure to spread knowledge through Adverse Event Report Data. According to FDA’s press release, “[t]his is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.” The data comes in the form of .csv file. From producer’s / distributor’s stand point, the most harmful piece of information comes in the column marked as “PRI_Reported Brand/Product Name.” While at times overly broad, some line items list in sufficient details the product name and brand. For example, “POLAND SPRINGS SPRING WATER” is on the list to have allegedly caused “DIARRHOEA, ABDOMINAL PAIN, RIGORS, NAUSEA” to a 29 year old male on December 2, 2003.” Good question is how it will affect imports or prospective food imports? FDA’s press release potentially provides answer as follows: The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products,…
Food and Drug Administration (FDA) continues to brainstorm the regulatory framework surrounding the word “healthy” on food products. September 2016 guidance advises that the “healthy” nutrient content claim can be used if the food: Meets specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber; The criteria are linked to elements in the Nutrition Facts label and serving size regulations; When used with an explicit or implicit claim or statement about a nutrient (e.g. “healthy, contains 3 grams of fat”), suggests that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations. As FDA continues to develop “healthy” definition ingredients, it seeks comments from the public. Federal Register Notice for the Guidance for Industry Federal Register Notice for the Request for Information Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages “Healthy” on Food Labeling
Read More When you see “healthy” on food package, what does it mean?
Food and Drug Administration posted Biennial Registration Renewal. All food facilities must renew their registration with FDA from October 1, 2016 through December 31, 2016. FDA renewal post is available at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm324780.htm. Registration requirement applies to domestic (U.S.) and foreign (non-U.S.) food facilities. Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.
FDA’s reporting requirements are relaxed with respect to active ingredient producer for drugs; trade names for biologics, drugs, tobacco, radiation products; intended use reporting for certain products; and device listing number for medical devices and biologics. See http://www.cbp.gov/sites/default/files/assets/documents/2016-Mar/FDA%20Webinar%20April%2023.pdf
Almost two years have passed since The Food Safety Modernization Act of 2011 (FSMA) was singed on January 4, 2011. Nine months after the signing, in September 2011, FDA announced the implementation of the fee provisions of section 107 of FSMA, where the U.S. Agent representing foreign food facility would be held responsible for the fees incurred in connection to reinspection and reinspection related costs. This week marks the kick-off of the FDA’s Biennial Registration Renewal for Food Facilities, and presents a great opportunity for U.S. Agents representing foreign food facilities to review their terms of representation. Prior to FSMA, U.S. Agent representing foreign food facility, acted merely as an information conduit. U.S. Congress decided to enhance the role of U.S. Agent, stating that “For fiscal year 2010 and each subsequent fiscal year, the Secretary shall … assess and collect fees from … the United States agent … for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.” See 21 USC 379j–31. Also, prior to FSMA, U.S. Agent could assist in registering and represent the foreign food facility for indeterminate amount of time. U.S. Congress decided that it would be better…
Read More FDA’s Biennial Registration Is Good News for U.S. Agents
On December 29, 2011, LawCustoms discussed registration technicalities by U.S. Agents with Food and Drug Administration (FDA) in the article “Non-U.S. Food Facility Registration Cancellation.” The article noted that FDA recommends foreign food facilities not to cancel their registration, stating that “food facilities should register only once.” The article also noted that this interpretation may be impractical in light of the contractual relationship between many U.S. Agents and foreign food establishments. If the U.S. Agent withdraws from representing foreign food facility, that Agent must notify FDA. 21 C.F.R. Sec. 1.234(a). If the facility, was registered online through FDA Industry Systems, then Agent has two practical ways of notifying FDA of its withdrawal. First, the Agent can cancel the registration notwithstanding FDA’s recommendation to the contrary. Second, the U.S. Agent or the foreign food facility may update the Section 7 of the registration form, which deals with the United States Agent. The problem with the second option is that Section 7 cannot be left blank. According to FDA, the system will not allow Section 7 be left blank. However, what if the U.S. Agent, who follows FDA’s recommendation, would like to delete his information from Section 7 (i.e. perform and update) and thereby withdraw from representation? Unless that Agent has…
Food and Drug Administration (FDA) still has a letter posted on their website advising foreign establishments to register only once: “Contrary to any suggestion by FDA Registrar Corp., food facilities should register only once. The registration does not expire.” This comment, made in response to the agent-principal agreement, fails to appreciate the contractual nature of the relationship. 21 C.F.R. Sec. 1.232(d) of the requires the registration for foreign facilities to include the name, address, phone number, and Emergency Contact phone number of the facility’s U.S. Agent. Additionally, foreign facility may authorize U.S. Agent to register the foreign facility with FDA. 22 C.F.R. Sec. 1.230. The nature of relationship between the U.S. Agent and the foreign facility can be of contractual nature, allowing one party with withdraw from the relationship. Therefore, if a party withdraws from the relationship, FDA must be notified pursuant to 21 C.F.R. Sec. 1.234(a): “Update requirements. The owner, operator, or agent in charge must submit an update to a facility’s registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. The owner, operator, or agent…
Read More Non-U.S. Food Facility FDA Registration Cancellation
With some meat and poultry exceptions, most of food, drugs, biologic, cosmetics, medical devices, tobacco and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to FDA jurisdiction when they are being imported or offered for import into the United States. Form FDA 2877 (outdated MS Word version is available here), Declaration for Radiation Standard, is required for radiation-emitting electronic products entering the United States. 21 CFR 1005 – 1050 addresses the performance standards for electronic products. If device is not listed as being subject to the performance standards for electronic products (ex. infra-red remote controls), then it does not need to be declared with FDA. Examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.15. Following are some of the links one might find useful: Action Levels for Poisonous or Deleterious Substances Center for Devices and Radiological Health Color Additives: Color Additives and Cosmetics Color Additives: Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices Cosmetics Drug Registration and Listing Flags, HTSUS HACCP: Seafood Import Refusal Reports Manuals (Compliance…
Read More Food and Drug Administration: General Overview of Issues Concerning International Trade
CUSTOMS BROKER LICENSE EXAM PREPARATION CLASSES for April 2021 Exam: January 7, 2021-March25, 2021.
Registration is Open at LawCustoms Store. Class details are available at Live Classes Page.
