Is this illegal? nootropics?

[VUKANoots]

Hey guys so I've started a nootropics business, and right now I am selling a tablets containing caffeine + L theanine. These are both substances that come from coffee beans and green tea so they're natural extracts.
I make the tablets at my house with a machine I have.

On my packaging I have the caffeine warning "CONTAINS CAFFEINE NOT RECOMMENDED FOR LACTATING WOMAN, PERSONS SENSITIVE TO CAFFEINE..... etc
It also specifies exactly how much caffeine and l theanine is contained.
I also have it clearly labeled as a DIETARY SUPPLEMENT

My question is is this now legal to sell? Do I have to get it reviewed by some regulatory body?
Do I need to have the MCC or some other council come and test the product and review the manufacturing conditions?


Really really really would appreciate anyone's help on this as I can't find definitive answers anywhere.

Thanks

(sorry for clickbait title lol)

 

[scudsucker]

Good luck:

http://www.nda.agric.za/vetweb/Legislation/Other acts/R_Medicines_and_related_substances.htm

Neither caffeine or L-theanine are scheduled drugs.

However, if you don't know about the law, when you are dealing with substances that may or may not be covered by the law.... I, for one, will not be buying anything from you.

 

[genetic]

My question is is this now legal to sell? Do I have to get it reviewed by some regulatory body?
Do I need to have the MCC or some other council come and test the product and review the manufacturing conditions?


Really really really would appreciate anyone's help on this as I can't find definitive answers anywhere.

Thanks

(sorry for clickbait title lol)

Legal to sell? NO. You'll have to get your product registered, tested and certified by the Medicines Control Council

http://www.sahpra.org.za/

This document lists the legal requirements to administer, sell or produce "medication" substances in SA;

http://www.mccza.com/documents/959cb9e1Test.pdf

 

[IzZzy]

Legal to sell? NO. You'll have to get your product registered, tested and certified by the Medicines Control Council

http://www.sahpra.org.za/

This document lists the legal requirements to administer, sell or produce "medication" substances in SA;

http://www.mccza.com/documents/959cb9e1Test.pdf

Only if he claims medicinal benefits

 

[genetic]

Only if he claims medicinal benefits

For personal use. Not for resale thereof.

 

[VUKANoots]

Thanks for the replies everyone - appreciate it a lot.

I’m not claiming any medicinal benefits and I know for instance neuroactive.co.za sells the same thing with this disclaimer (image below).

The disclaimers specifically mention that the product has NOT been evaluated by the MCC and is not intended to treat any disease. They also say use at your own risk.

They also sell a lot of research chemicals with the same disclaimer so I guess that's really the key?

I just can't figure out if I need to have my manufacturing process reviewed or approved under the cGMP (current Good Manufacturing Process)? Or any other approvals.

Is this necessary? We are in the very early days so if we can avoid this it would be great but obviously we don't want to get fined etc

Thanks again for the help

 

[chicken247]

Who's business is it what i put into my body as long as i don't harm anyone?

just label your **** with ingredients and side effects.

The state has been intrusively abusive and punitive for to long about a lotta ****.