Here are the answers of the most common questions we are asked from our valued customers.

A. Tablets and Capsules: MOQ 300,000, lowest quantity is 100,000

Powder and Liquid: MOQ is 3,000 bottles, lowest quantity is 1,500

According to FDA 21 CFR Part 101.100, incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food are exempt from labeling requirements. This includes substances that are present due to being part of another ingredient, processing aids, and substances migrating from equipment or packaging. These additives must not contribute to the food’s taste, nutritional value, flavor, or color to qualify for this exemption.

EXAMPLE:
In our estimation a good example of this is the widespread use of HPMC capsules, they are frequently just labeled as HPMC capsules or Veggie Capsules or Vegetarian Capsules. However those capsules contain multitudes of ingredients consumers never hear about. We have it on good authority (industry insider in the empty capsule business) until 2 years ago about 100% of all HPMC capsules contained carrageenan and surfactants. Currently many of the major capsule manufacturers manufacture without those ingredients and claim to only use HPMC capsules. 

We at PureNSM have received a guarantee that the only ingredient used in our HPMC capsules is HPMC. We source from a North American brand and have analyzed the capsules repeatedly for purity. We know for a fact that many capsule manufacturers still use carrageenan. In our estimation about half the HPMC capsules on the market contain carrageenan. Furthermore, 99% of brand owners have no idea that their HPMC capsules may contain carrageenan. 

MAGNESIUM STEARATE

Under FDA regulations, specifically 21 CFR Part 101.100, magnesium stearate would generally need to be declared on the label of a dietary supplement. This is because magnesium stearate is typically used as a flow agent or lubricant in supplement manufacturing, which means it has a technical or functional effect in the product. Therefore, it does not qualify as an incidental additive that can be exempt from labeling.

For it to be exempt, it would need to be present at an insignificant level and not have any technical or functional effect in the finished product, which is not typically the case for magnesium stearate in supplements.

The only thing the manufacturer needs to claim is that the Magnesium Stearate is NOT added into the product for TECHNICAL reasons. In our estimation about 99% of all manufacturers add about 3% Magnesium Stearate into all customers products WITHOUT ever disclosing that fact to label owners, even if the label owner asks on email if magnesium stearate is added many factories will hide the fact at all costs. The situation is so bad that a guarantee is now needed from manufacturer:

100% Money Back Plus $10,000: If you find we have used magnesium stearate in your product without your permission

PureNSM offers this guarantee. https://purensm.com/quality-transparency-guarantee/ 

If you are concerned about your CMO using magnesium stearate without your permission then send us your products and we can help you analyze if magnesium stearate is in the product. We do so with major ISO certified laboratories we work with. They use many methods but one of them is High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS). These techniques are highly sensitive and can typically identify concentrations as low as 3% or even lower, depending on the specific setup and calibration of the equipment. The sensitivity of these methods makes them suitable for detecting minor components in complex mixtures, such as dietary supplements.