You want me to ingest what?
You want your customers to put your product in their bodies.
Pretty sure FDA is going to be “all over that.”
How “all over?”
The Current Good Manufacturing Practices (cGMP) final rule establishes the minimum cGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the efficacy, quality, purity, and safety of your dietary supplement.
Wanna give these 20 sections a read?
Oh, I’ve got plenty to say on this topic.
But that’s for another day or blog post.
Here’s an important question: Do you know what the last dietary supplementary guidance is? How about the answers to the questions below?
How many can you confidently answer?
Here’s my rating scale. Let’s see how you do.
? 10: You’re a superstar. What are you doing here? You’ve totally got this.
?? 9: Impressive! How can I complement what you’re already doing?
? 8 or fewer: Let me give you a hand there. Let’s talk for 30 minutes, see if you like what you hear.
- Does FDA recognize the term nutriceutical?
- How do my claims affect if FDA considers my product a dietary supplement or a drug?
- My product is a widely used dietary supplement in other countries. Does that mean it will be a dietary supplement here?
- What does it mean for my ingredient to be sourced under fair trade?
- What do I need to be worried about in my claims with the FTC beyond what FDA would focus on?
- What is DSHEA and how does it affect what supplements can easily be brought to market?
- What is GRAS and how does it affect what supplements can easily be brought to market?
- What is the difference between the GRAS path to market and an NDI path to market?
- What are the good manufacturing practices required for dietary supplements?
- What are the labeling requirements for dietary supplements?
So what’s next?
That’s up to you.
+ Michelle +