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- CHAPTER 5 Pre-market Notification
§5.3 ". . . shall be deemed adulterated . . ."
Jurisdiction | United States |
Publication year | 2022 |
§5.3 ". . . shall be deemed adulterated . . ."
The phrase "shall be deemed adulterated" is not defined in the Act or even the '38 Act; referral back to pre-1906 food and drug laws may provide insight. Under common law, delivering food containing ingredients that may be injurious to health was deemed a misdemeanor.55 Early statutes using the term "adulteration" or variations (i.e., "adulterated") indicated it occurred when articles were "inferior in strength and purity" to pharmacopoeia standards.56 In a later statute, adulteration for foods was started to occur when a substance was mixed with the food to "reduce or lower or injuriously affect the quality or strength" of the food.57
Intent of the defendant was at issue as guilt under misdemeanor required the defendant to have knowledge the ingredient would be injurious to health.58 In statutes codifying common law and in the 1906 Food and Drug law, to be in violation of the statute, possessing knowledge of the adulteration was not a requirement. "Shall be deemed adulterated" may codify no need for knowledge to violate the statute. The mere fact that the article is in a certain condition leads to violation of the statute, whether or not the perpetrator knew of the condition.
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Notes:
[55] See also, State v. Smith, 10 N.C. 203 (1824).
[56] 9 Stat. L. 237 (1848); see also 25 Stat. L. 549...
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- CHAPTER 5 Pre-market Notification
- CHAPTER 5 Pre-market Notification
- §5.1 "Pre-market Notification" for New Dietary Ingredients
- §5.2 "A dietary supplement . . ."
- §5.3 ". . . shall be deemed adulterated . . ."
- §5.4 ". . . under Section 402(f) unless it meets on of the following . . ."
- §5.5 First Scenario to Overcome Assumption of Adulteration: ". . . contains . . . dietary ingredients . . . which have been present in the food supply . . . in a form . . . [that] has not been chemically altered . . ."
- §5.6 Second Scenario to Overcome Assumption of Adulteration: Pre-market Notification Filing
- §5.7 The Manufacturer's or Distributor's Conclusion
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