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. 2023 Jul 26;15(15):3320. doi: 10.3390/nu15153320

Table 3.

Regulations/laws and regulatory requirements of dietary supplements in different countries (USA, EU, China, and Algeria) [13,22].

USA EU China Algeria
Regulatory agency Food and Drug Administration (FDA)
  • The European Commission and the competent authorities

  • EFSA (European Food Safety Authority), if centralized procedures apply

  • CFDA (China Food and Drug Administration)

NA
Regulation and law
  • FD & C Act (Federal Food, Drug, and Cosmetic Act)

  • DSHEA (Dietary Supplement Health and Education Act)

  • NLEA (Nutrition Labeling and Education Act)

  • CGMP (Current Good Manufacture Practice: manufacturing, packaging, labeling, or holding operations for DS)

  • 2002/46/EC

  • EC No 1924/2006

  • Health Food Registration and Filing Regulation

  • Guidelines for the application of health food registration

  • Health Food Filing Work Guide

  • National food safety standard-Health foods GB 16740-2014 [23]

/
Compliance process
  • The manufacturers and distributors are responsible

  • Notification/registration: DS containing a new ingredient

Notification/registration
  • Registration: use the ingredients outside the raw material dictionary and excipient dictionary

  • Filing: use the ingredients listed in the raw material and excipient dictionary

/
Category Foods + + + +
Medicines
Manufacturer Registration +
(Limited)
+
Presence of a positive list + + NA
Good Manufacturing Practice (GMP) + +
(HACCP)
+ NA
Clinical trials of individual products +
(New ingredients)
+
(New ingredients)
NA
Obligated to display the usage and dosage + + + NA
Serious adverse event reporting + + NA
Labeling and packaging + + + NA
Shape description + + Often NA
Advertising requirements + + + NA
Health claims NA

+/−: presence/absence of the factor; NA: not annotated.