Friday FDA Dump

Via LitBrit: FDA Office of Regulatory Affairs IMPORT ALERT #99-29 – 4/27/07:

“DETENTION WITHOUT PHYSICAL EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS”

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

(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).

PRODUCTS:

• Wheat Gluten
• Rice Gluten
• Rice Protein
• Rice Protein Concentrate
• Corn Gluten
• Corn Gluten Meal
• Corn By-Products
• Soy Protein
• Soy Gluten
• Proteins (includes amino acids and protein hydrosylates)
• Mung Bean Protein

PRODUCT CODES:

• 02G[][]08 – Soy Bean Meal/Powder/Gluten/Protein Isolate
• 18E[][]03 Soy Protein Powder
• 02F[][]08 Wheat Gluten
• 02E[][]06 – Wheat Flour Gluten
• 71M[][]01 Wheat Gluten
• 02D[][]12 Rice Protein
• 02D[][]13 Rice Gluten
• 71I[][]03 Rice Protein
• 71G[][]02 – Corn Gluten
• 02B[][][][] Milled Rice Products
• 54[][][][][]- Amino acids and protein hydrosylates

PROBLEM: Poisonous or Deleterious Substance
Unfit For Food
Unsafe Food Additive

PAF: PES

COUNTRY: China (CN)

MANUFACTURER/SHIPPER: All

CHARGES: “The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance, which may render it injurious to health [Adulteration, section 402(a)(1)]”

and/or

“The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]”

and/or

“The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for
food [Adulteration, 402(a)(3)]”