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