5 replies to this topic

[zechzplz]

Hi, I was reviewing 21 CFR 101.100(a)(2)(ii) and it states.

 

"A counter card, sign, or other appropriate device bearing prominently and conspicuously, but in no case with lettering of less than one-fourth of an inch in height, the information required to be stated on the label pursuant to section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (the act)."

 

Okay... so I would like to know what information is required to be stated per 403(i)(2). When I go to the United States Code, it skips from section 399i to section 451 (see attachment). 

 

Where is 403(i)(2)? 

 

I also realize that I am not well-versed in regulation. Is it correct to say that what's listed in eCFR is regulation and what's listed in the US Code is legislation? Any help in understanding these legal texts would be appreciated, thank you! 

Attached Files

•  FD&C skip.png   7.09KB   0 downloads

[acarver]

Google search comes up with this: Section 403 (i) (2) of the FD&C Act permits a color to be listed on a food label without specifically naming the color used. The section also provides for exemptions from the required declaration of ingredients where such declaration is impracticable or results in deception or unfair competition. 

[zechzplz]

Thanks! This is helpful. Though I'm curious how I actually access section 403(i)(2) of the FD&C (like where do I see the full text? ). 

[kingstudruler1]

https://www.fda.gov/...chapter-iv-food

 

this might confuse you more.   

[zechzplz]

This does confuse me more D: 

 

https://www.fda.gov/...chapter-iv-food

 

this might confuse you more.   

[kingstudruler1]

It took me a while to find this (original FDCA) with the info you were looking for.  It corresponds to the conversion chart I linked earlier.   

 

https://www.govinfo....f/COMPS-973.pdf

 

I dont know the history of the numbers.   I believe it has something to do with converting FDCA to Title 21 and updates.  

 

FDCA 403 (i)(2) = 21 cfr 343(i)(2)

Edited by kingstudruler1, 16 April 2025 - 05:43 PM.