IA #41-03 - 8/11/03; IMPORT ALERT #41-03 "DETENTION WITHOUT PHYSICAL EXAMINATION OF ADULTERATED *** AND MISBRANDED *** MEDICAL FOODS" Attachment A - 3/17/04; TO: IMPORT PROGRAM MANAGERS NOTE: This revision adds a misbranding charge, a PAF for labeling, and a second attachment, ATTACHMENT B, which provides guidance regarding personal importation. The REASON FOR ALERT SECTION has also been revised. Changes are bracketed by asterisks (***). TYPE OF ALERT: Detention Without Physical Examination (DWPE) (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). PRODUCT: Medical Foods Medical foods are defined as foods that are formulated to be consumed orally or administered enterally under the supervision of a physician and are intended for the dietary management of a specific disease or condition that has nutritional requirements. PRODUCT CODE: 41G[][]01 Nutritionally Complete Formulation 41G[][]02 Nutritionally Incomplete Formulations (Mudulars-may be protein, carbohydrates or fat modulars intended to be mixed with other products prior to use) PROBLEM: Adulterated and/or Misbranded PAF: MIC NIC *** LABELING *** PAC FOR COLLECTION: 21002 COUNTRY: All (ZZ) MANUFACTURER/ SHIPPER FEI#: See attachment A MPORTER'S ID#: N/A CHARGES: 1. For medical foods imported from foreign firms that fail to follow 21 CFR 110 or otherwise prepare pack or hold medical foods under insanitary conditions whereby such products may have been rendered injurious to health (Good Manufacturing Practices) "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration 402(a)(4)]." 2. For medical foods that are violative based solely on sample analysis. "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a microbiological contaminate which may render it injurious to health [Adulterated 402(a)(1)"; or "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated in that a valuable constituent has been in whole or in part omitted or abstracted therefrom [Adulterated 402(b)(1)". *** 3. "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that it's labeling appears to be false and misleading [Misbranding 403(a)(1)]." *** RECOMMENDING OFFICE: CFSAN/OFP/DOEP/ IMPORTS BRANCH, HFS-606 REASON FOR ALERT: In general, medical foods are analogous to infant formulas, in that the technology base is similar for the manufacture of both products. Adulterated medical foods may constitute short and long-term health hazards to the susceptible populations who consume these products. Potential health hazards associated with medical foods include compositional errors that result in microbiological and/or environment contamination. For this reason, the Center has identified medical foods as a high-risk food category. Therefore, the Agency is committed to assuring the continued safety and integrity of medical foods through annual inspection of all manufacturers of such products and routine analyses of medical food products. A firm may be listed on *** Attachment A *** either because the most recent FDA inspection conducted at the plant revealed that the plant was not following 21 CFR 110 or was otherwise preparing, packing, or holding products under insanitary conditions whereby such products may have been rendered injurious to health, and/or because one or more products manufactured at the plant have been analyzed by FDA and classified as violative. *** In addition, a firm may be listed on Attachment A because the label misstates the action amount of an ingredient. FDA analysis of a medical food marketed as a low carbohydrate product revealed that the product may contain as much as 11 grams of carbohydrate instead of the labeled 3 grams. Because the label misstates the actual amount of carbohydrate in the product, this also results in a significantly lower fat: carbohydrate + protein ratio than what is stated on the label. *** GUIDANCE: Districts may detain without physical sampling and analysis all shipments of the specified products from the manufacturers listed in *** Attachment A *** of this alert. *** Refer to Attachment B for further guidance regarding personal importation. *** For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605. PRIORITIZATION GUIDANCE: I FOI: No purging is required KEYWORDS: Medical Foods, Enteral Nutrition, Microbiological Contamination, Nutrient Deficiencies or Nutrient Overages, *** Misbranding *** PREPARED BY: Dave Krawetz, DIOP, (301) 443-6553 Brenda Aloi, CFSAN, (301) 436-2065 Attachment A- Import Alert #41-03 3/17/04 Firms and Products recommended for DWPE FIRM PRODUCT/PRODUCT CODE PROBLEM