A weekly live web event dedicated to issues related to international trade.
Links used during the stream:
PERSONAL PROTECTIVE EQUIPMENT (PPE)
Martin K. Behr’s Presentation Slides:
FDA’s PPE dedicated page:
CBP Dedicated COVID page:
CSMS #44243021 – GUIDANCE: Section 301 Tranche 1 – $34B Action Extension of Product Exclusions from China:
CSMS #44279197 – CORRECTION- GUIDANCE: Caribbean Basin Trade Partnership Act (CBPTA) is scheduled to expire October 1, 2020
FDA Import Alert Database
Import Alert 99-39
FDA’s Dietary Supplement Dedicated Page:
Concept of “dietary ingredient”
Food Labeling Guide:
Small Business Nutrition Labeling Exemption
Small business exception protocol described in 21 CFR 101.36(h)(2), Falls back on 21 CFR 101.9(j)(18)(ii).
Sample small business exception form:
Naming of Ingredients: Must use standardized common name 21 CFR 101.4(h).
Herbs of Commerce – see 21 CFR 101.4(h)
FDA 101: Dietary Supplements:
21 C.F.R. § 101.36(h)(2) further requires that the product’s “labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.”
“Health claim” is defined as a statement describing the relationship between a substance and disease in the labeling of foods, including dietary supplements. 21 C.F.R. § 101.14(a)(1):
“Substance” is defined as “a specific food or component of food, regardless of whether the food is in conventional food form or a dietary supplement that includes vitamins, minerals, herbs, or other similar nutritional substances.” Id. at (a)(2)
“Disease” or health-related condition means damage to an organ, part, structure, or system of the body such that it does not function properly. Id at (a)(4).
FDA Guidance Document, Guidance for Industry: FDA’s Implementation of Qualified Health Claims, How are health claims different from statements about dietary guidance? (May 2006)
If statement describes structure/function and therefore requires disclaimer. 21 C.F.R. § 101.93.
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading.