FDA Compliance page

Infiniti Creations prides itself in ensuring 100% accurate label compliance as per FDA 21 CFR 111. While we are not FDA compliance consultants, we will support and advise along the way as we create and generate your private label for your company. However, that being said once the product is privately branded to your company, it becomes your property, your product, your label and ultimately all liability within the label and its claims becomes your responsibility. What this means is that we will build your product as you spec to us, if there are no specifications provided we will default to internal specifications as laid out in our standard operating procedures. As a seller of the product you are also required to register with the FDA, this will in turn build credibility and reputability with your company as a seller of food grade products/supplements. You can register your company here for free and it takes only about 10-15 minutes of your time,

 

 

You can also pay an outsourced company to register your company automatically every year for around 100$. Currently we use..

 

The advantage to an outsourced agent registering you with the FDA is #1 you never need to remember to renew your registration and #2 you get a fancy certificate you can freely display in your office, or on your website.

 

For a complete & detailed guide for FDA label compliance we suggest you review this link below….

 

We suggest you perform your due diligence as the seller of this product and ensure and conform to all FDA guidelines and regulations. Should you have any additional questions regarding this please don’t hesitate to ask your account manager.

 

Please note that all purchases made with Infiniti Creations are bound to our terms and conditions for sale. This includes our quality agreement relevant to FDA responsibilities and guidelines. We have provided a link below that will list the expected responsibilities of each party. Our quality agreement should be referred to in detail below….

In regards to FTC regulations and guidelines, you are ultimately responsible for all claims, its marketing, its benefits, its side effects, etc.

A guide for FTC advertising guidelines and support can be found here…

 

 

If you list any claims they should be substantiated by a 3rd party reputable clinical study. Listing claims on the label just because “other companies are doing it” cannot be your reason for listing it on the label. Infiniti is NOT responsible for substantiating any claims you make on your label. Drug claims that would indicate the product can “diagnose, cure, prevent, treat” diseases cannot be used on any supplements and will not be added even if requested. If you have an existing label that includes a drug claim we may exercise the right to remove it even without notification.

 

————————————————————————————————————————————————-

 

All sales are bound to our

FDA Compliance Agreement – https://www.infiniticreationsllc.com/fda-label-compliance/

Refund Policy – https://www.infiniticreationsllc.com/shipping-policies/

Quality Agreement – https://infiniticreationsllc.sharefile.com/share/view/sa53fa53c2dd41768

 

By purchasing product, you have read, understand, and agree to these conditions for sale and resale of product