C.F.R.
»
Title 21
» CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS › Subpart A—General Provisions
(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:
(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and
(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.
Notes of Decisions
World Nutrition Inc. v. Advanced Enzymes USA (D. Ariz. 2024).
“21 C.F.R § 111.1(a). Not only does 14 the record fail to rebut the presumption, but it also affirmatively establishes that 15 WNI was subject to GMP regulations and never received certification.”
United States v. Bioanue Labs. Inc (M.D. Ga. 2021).
“The Government argues that 21 C.F.R. § 111.1 applies to the defendants’ new business because it “would ‘hold’ supplements when it receives them from the manufacturer and then distribute[] them to consumers through interstate commerce.”
— 21 C.F.R. § 111.1(a) — 1 case
World Nutrition Inc. v. Advanced Enzymes USA (D. Ariz. 2024).
“21 C.F.R § 111.1(a). Not only does 14 the record fail to rebut the presumption, but it also affirmatively establishes that 15 WNI was subject to GMP regulations and never received certification.”
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