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Dear Colleagues, Please see the attached regulatory update. Late last week, the FDA issued three import alerts (IA) which could impact dietary supplements and bulk dietary supplement ingredients. This step by the FDA may help in slowing the entry of intentionally tainted or adulterated products from entering the U.S. market. Several product categories are likely to be affected including weight loss, male sexual performance, products designed for pain management, and sports supplements. Additional refusals are likely for products making disease claims or those that may be mislabeled. I hope you find this information timely and helpful. Best, Larisa Regulatory News Summary March 4, 2017 Import Alerts Import alerts are a very powerful regulatory tool. There is a different regulatory expectation. During a domestic inspection or investigation, the FDA agent must prove there is a violation by collecting evidence. Typically, evidence would include collecting samples to be submitted and tested at an FDA laboratory to prove there is a contaminant or pharmaceutical adulterant. For an import, the Food, Drug, and Cosmetic Act is written as any product that “appears” to be in violation, can be refused. If a product is refused, it must be exported or destroyed. I have cut and pasted from the FDA website Import Programs/Import Alerts below. The import alerts issued yesterday include: 1) The first alert (Import Alert #54-16) includes 12 pages of products and product types. Import Alert Name: "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" Reason for Alert: FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs). Here is the link: http://www.accessdata.fda.gov/cms_ia/importalert_1141.html The second IA (IA #99-39) includes a list of 93 pages of potential products and product categories subject to detention without physical examination from various countries. Import Alert # 99-39 Published Date: 03/02/2017 Type: DWPE Import Alert Name: Detention Without Physical Examination of Imported Food Products That Appear To Be Misbranded Reason for Alert: NOTE: The revision of this Import Alert dated 10/02/2015 updates the Alert to transition all charges currently reflected in Import Alert 99-20 "Detention without Physical Examination Of Imported Food Products Due to NLEA Violations" to this Import Alert. Import Alert 99-20 will be deactivated upon publication of this major revision. All firms currently listed on the RED LIST of IA 99-20 will be moved to the RED LIST of this alert. Changes are bracketed by asterisks (***). Link: http://www.accessdata.fda.gov/cms_ia/importalert_1144.html Finally, Import Alert # 66-41 Published Date: 03/02/2017 Type: DWPE Import Alert Name: Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. Reason for Alert: NOTE: Revision to this Import Alert dated 10/19/2010 updates the language to the "Reason for Alert" and "Guidance" sections. Changes are noted and bracketed by three asterisks (***). Link: http://www.accessdata.fda.gov/cms_ia/importalert_190.html Food, Drug, and Cosmetic Act Under the Food, Drug and Cosmetic Act Section 801 - Imports and Exports, the FDA has the authority to refuse admission of an article if it appears from the examination or otherwise to be 1) made under unsanitary conditions, 2) forbidden or restricted for sale in the country produced or from which it was exported, 3) such article is adulterated, misbranded, or in violation of 505 (New Drugs). Here is a link to the FDA page related to Import Actions & Enforcement. This page further describes Import Alerts. https://www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/default.htm I have cut and pasted the information shown below from this site. “Import Alerts Import alerts inform FDA field staff that the agency has enough evidence or other information to allow for Detention Without Physical Examination (DWPE) of products subject to an import alert. Products are subject to DWPE based upon past violations. These violations could be related to the product, manufacturer, shipper and/or other information indicating the product may be in violation of FDA laws. Depending on the specific import alert, shipments can still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance. Before shipping into the U.S., importers should be aware of whether or not the product is subject to DWPE, causing it to be on the red list of an Import Alert. Import alerts also: o Prevent potential violative products from being distributed into the United States o Free up agency resources to examine other shipments o Provide uniform coverage across the country o Place the responsibility back on the importer. (It is the responsibility of the importer to ensure that the products being imported into the U.S. are in compliance with our laws and regulations.) FDA has more than 250 active import alerts that prevent potentially violative products from entering U.S. commerce." 
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