October 6, 2020 LawCustoms Stream: Personal Protective Equipment (PPE); Dietary Supplements

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: https://drive.google.com/file/d/11YS4dLl68etjWETIJ4di1XR50YqFVJJ9/view?usp=sharing FDA’s PPE dedicated page: https://www.fda.gov/industry/importing-covid-19-supplies/information-filing-personal-protective-equipment-and-medical-devices-during-covid-19 CBP News: https://www.cbp.gov/newsroom/local-media-release/500000-counterfeit-n95-masks-seized-chicago-cbp CBP Dedicated COVID page: https://www.cbp.gov/newsroom/coronavirus…

October 6, 2020 LawCustoms Stream: Personal Protective Equipment (PPE); Dietary Supplements

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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:

https://drive.google.com/file/d/11YS4dLl68etjWETIJ4di1XR50YqFVJJ9/view?usp=sharing

FDA’s PPE dedicated page:

https://www.fda.gov/industry/importing-covid-19-supplies/information-filing-personal-protective-equipment-and-medical-devices-during-covid-19

CBP News:

https://www.cbp.gov/newsroom/local-media-release/500000-counterfeit-n95-masks-seized-chicago-cbp

CBP Dedicated COVID page:

https://www.cbp.gov/newsroom/coronavirus

ANNOUNCEMENTS

CSMS #44243021 – GUIDANCE: Section 301 Tranche 1 – $34B Action Extension of Product Exclusions from China:

https://content.govdelivery.com/bulletins/gd/USDHSCBP-2a3184d?wgt_ref=USDHSCBP_WIDGET_2?utm_source=google&utm_medium=google&utm_term=(not%20provided)&utm_content=undefined&utm_campaign=(not%20set)&gclid=undefined&dclid=undefined&GAID=false

CSMS #44279197 – CORRECTION- GUIDANCE: Caribbean Basin Trade Partnership Act (CBPTA) is scheduled to expire October 1, 2020

https://content.govdelivery.com/bulletins/gd/USDHSCBP-2a3a59d?wgt_ref=USDHSCBP_WIDGET_2?utm_source=google&utm_medium=google&utm_term=(not%20provided)&utm_content=undefined&utm_campaign=(not%20set)&gclid=undefined&dclid=undefined&GAID=false?utm_source=google&utm_medium=google&utm_term=(not%20provided)&utm_content=undefined&utm_campaign=(not%20set)&gclid=undefined&dclid=undefined&GAID=false

DIETARY SUPPLEMENTS

FDA Import Alert Database

https://www.fda.gov/industry/actions-enforcement/import-alert

Import Alert 99-39

https://www.accessdata.fda.gov/CMS_IA/importalert_1144.html

FDA’s Dietary Supplement Dedicated Page:

https://www.fda.gov/food/dietary-supplement

Concept of “dietary ingredient”

https://uscode.house.gov/view.xhtml?req=(title:21%20section:321%20edition:prelim)%20OR%20(granuleid:USC-prelim-title21-section321)&f=treesort&edition=prelim&num=0&jumpTo=true

Food Labeling Guide:

https://www.fda.gov/media/81606/download

Small Business Nutrition Labeling Exemption

https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/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:

https://drive.google.com/file/d/15dTBgHy0Jb-0RpA4aPX4-QqZJjpNNwJV/view?usp=sharing

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:

https://www.fda.gov/consumers/consumer-updates/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):

https://www.ecfr.gov/cgi-bin/text-idx?SID=2f3bf521641fddc2e9edcaac57c2fb2d&mc=true&node=se21.2.101_114&rgn=div8

“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)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-implementation-qualified-health-claims

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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food

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