Import Alert 41-03

(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).

Import Alert # 41-03

Published Date: 12/10/2020

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Adulterated and Misbranded Medical Foods"

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 the Red List 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 the Red List because the label misstates the active amount of an ingredient. For example, 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 on the attachmnet for this alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Medical Foods

Charge:

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), charge:

"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)]."

OASIS charge code - MFR INSAN

2. For medical foods that are violative based solely on sample analysis, charge:

"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)]."

OASIS charge code - as appropriate

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)]."

OASIS charge code - OMMITTED

3. For products that are misbranded, charge:

"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)]."

OASIS charge code - FALSE

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)