"Is a major food allergen that has been unintentionally added to a food as a result of cross-contact subject to FALCPA's labeling requirements?" is a question FDA answers in the second edition of its industry guidance on the Food Allergen Labeling & Consumer Protection Act of 2004. According to the document, major food allergens that are "unintentionally" added to a food due to cross-contact are not subject to FALCPA labeling requirements. The agency first released the question-and-answer guidance in October and expects to issue new editions as more questions are posed by industry (1"The Tan Sheet" Oct. 24, 2005, p. 10). The deadline for FALCPA labeling compliance is Jan. 1...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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