The United States Food and Drug Administration (“FDA”) is cracking down on the importation of unapproved new drugs with regards to personal use. Import Alert #66-41, “Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.” (“IA 66-41”) was most recently published on September 23, 2010. IA 66-41 contains a Red List, a list of importers whose products are automatically detained for FDA violations, of over 400 firms on the charge of importing misbranded unapproved new drugs.

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U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) will soon initiate a major enforcement initiative against cosmetics product labels bearing illegal drug claims, including “SPF,” “anti-aging,” or “anti-wrinkle,” according to

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As of May 17, 2010, the U.S. Food & Drug Administration (FDA) has added 85 Firms to Import Alert #45-02, “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors” (IA 45-02). These 85 new firms have been added to the alert since January of this year – less than a 5 month period.

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On April 1, 2010, U.S. Food & Drug Administration (FDA) updated Import Alert #71-04 by placing three additional firms on the “Red List”, which subjects them to “Detention Without Physical Examination Of Animal Feeds, Other Than Pet Treats, Due To The Presence Of Salmonella” (“IA #71-04”). FDA enforces all foreign and domestic animal feeds, pet foods and pet toys. “These recent enforcement actions occurred due to surveillance by FDA’s SWID [Southwest Import District], which found Salmonella in products made from sheep meat.” stated Benjamin L. England, of FDAImports.com, LLC, “Congress drafted the FDCA (Food Drug and Cosmetic Act) to regulate pet food almost the same as human food for a reason. Americans love their pets and this puts political pressure on FDA to give attention to imported pet food safety.”

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On April 8, 2010, U.S. Food & Drug Administration (FDA) added sixteen (16) new firms to Import Alert #99-08, “Detention Without Physical Examination Of Processed Foods for Pesticides”. (IA 99-08). FDA has jurisdiction and enforcement power over most processed foods, whether foreign or domestic. FDA is now requiring these 16 foreign food processors to provide a valid certificate of analysis, showing that their products do not contain illegal residue of certain pesticides.

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On March 09, 2010, U.S. Food & Drug Administration (FDA) issued

Import Alert #99-20, “Detention Without Physical Examination of Imported Food Products Due to Nutritional Labeling Education Act (NLEA) Violations”. (IA 99-20).  FDA enforces all laws and regulations related to “Front of Package” labeling and Nutritional Facts Panels.  This applies to both imported and domestic products.  According to Benjamin L. England, of FDAImports.com, LLC, despite NLEA being issued in 1994, “…the new Import Alert makes it clear FDA is substantially increasing its enforcement of food manufacturers and importers, under this statute. FDA will stop importers from selling products with illegal claims on their labels.”

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Earlier this month (March 3, 2010), U.S. Food & Drug Administration Commissioner Margaret Hamburg issued a Press Release announcing a major and broad initiative to increase FDA enforcement against illegal claims on food labeling, including unauthorized Nutrient Content Claims, health claims, and all drug and disease claims. FDA is also committed anew to cracking down on technical violations on both the Front of Package labeling and on Nutrition Facts Panels. FDAImports.com, LLC, a US-based FDA consulting practice owned by Benjamin England, a 17 year FDA veteran with over 20 years of practical FDA labeling compliance experience, believes that this is the beginning of a major effort to stop imported foods, imported beverages, and imported dietary supplements in their tracks before they are able to reach US consumers. “The easiest violation for FDA to find is a labeling violation,” says England at FDAImports.com. “FDA does not have to test the product to find the problem. The inspector just looks at the label,” he continued. Food labeling, beverage labeling and dietary supplement labeling requirements can be highly technical, as several dozen domestic and foreign food and beverage manufacturers learned this month.

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