A. Yes, if you ship directly from a supplier and supply COA.

A. Four to eight weeks, depending on production schedule.

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

A. All testing required by FDA’s GMP. This includes micro, heavy metal,
identity of raw materials, purity, and finished goods testing.

A. It’s a regulation designed to protect consumers from toxins,
unfortunately, it disproportionally affects botanical supplements and
unfairly so, since herbs often contain naturally occurring lead in the
product. The lead levels have to be tested, if not the label owner can
be on the hook for massive fines even if located outside of California.

A. They verify our GMP certification. Please request the details from us.

A. Allowable claims that stay within FDA’s GMP regulatory framework
and do not raise red flags with Amazon and other sales channels.

A. Yes, please visit
www.purensm.com

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.

With Us, You Get a Choice… Not a 3% Rule!!!

What is the 3% “Rule” About?

When it comes to manufacturing supplements, you deserve transparency, control, and flexibility. At PureNSM, we’re proud to offer you a choice that meets your unique priorities. Whether you aim to maximize cost savings or create truly pure products, we empower your brand with a transparent approach tailored to your goals.

Option 1: With Magnesium Stearate – Maximize Cost Savings

Magnesium stearate is a widely used additive in the supplement industry, acting as a lubricant to ensure smooth production processes, sometimes allowing encapsulations to go twice as fast. It significantly reduces manufacturing costs by speeding up production, preventing machinery clogs, and ensuring consistent capsules or tablets. For brands looking to make high-quality supplements at a lower cost, this option can be a strategic choice.

Please read answers to the above question:
Why is it legal for CMOs to put magnesium stearate in products without telling brand owners?

The rationale behind this regulation is to simplify food labeling by ensuring that only those additives that have a significant impact on the product are listed.

Incidental additives are considered to have no technical or functional effect in the food, meaning they do not alter the product’s qualities in a way that affects consumer decisions or safety. This regulatory approach helps reduce labeling complexity, making it easier for manufacturers to comply with labeling requirements while maintaining transparency and safety standards for consumers.

If a manufacturer does not have access to a BSL-2 (Biosafety Level 2) lab, they cannot ensure that their equipment is functioning correctly for detecting pathogens. The absence of a BSL-2 lab means that they lack the essential safety protocols and containment measures required for reliable pathogen testing. This deficiency can lead to several risks, including potential contamination of samples, inaccurate test results, and an inability to verify the effectiveness of their detection equipment.

Without the specialized environment and safeguards provided by a BSL-2 facility, manufacturers face significant challenges in maintaining the high safety and quality standards necessary for pathogen detection. This not only compromises the reliability of their testing processes but also poses a risk to lab personnel and the integrity of other samples. Therefore, having a BSL-2 lab is crucial for accurately assessing equipment functionality and ensuring safe and effective pathogen detection.

If a manufacturer does not have access to a BSL-2 (Biosafety Level 2) lab, they cannot ensure that their equipment is functioning correctly for detecting pathogens. The absence of a BSL-2 lab means that they lack the essential safety protocols and containment measures required for reliable pathogen testing. This deficiency can lead to several risks, including potential contamination of samples, inaccurate test results, and an inability to verify the effectiveness of their detection equipment.

Without the specialized environment and safeguards provided by a BSL-2 facility, manufacturers face significant challenges in maintaining the high safety and quality standards necessary for pathogen detection. This not only compromises the reliability of their testing processes but also poses a risk to lab personnel and the integrity of other samples. Therefore, having a BSL-2 lab is crucial for accurately assessing equipment functionality and ensuring safe and effective pathogen detection.

If a manufacturer does not have access to a BSL-2 (Biosafety Level 2) lab, they cannot ensure that their equipment is functioning correctly for detecting pathogens. The absence of a BSL-2 lab means that they lack the essential safety protocols and containment measures required for reliable pathogen testing. This deficiency can lead to several risks, including potential contamination of samples, inaccurate test results, and an inability to verify the effectiveness of their detection equipment.

Without the specialized environment and safeguards provided by a BSL-2 facility, manufacturers face significant challenges in maintaining the high safety and quality standards necessary for pathogen detection. This not only compromises the reliability of their testing processes but also poses a risk to lab personnel and the integrity of other samples. Therefore, having a BSL-2 lab is crucial for accurately assessing equipment functionality and ensuring safe and effective pathogen detection.

Proposition 65, commonly referred to as Prop 65, is a California regulation that mandates businesses to provide clear warnings about significant exposures to chemicals known to cause cancer, birth defects, or other reproductive harm. This law is critical for supplement brand owners because it dictates labeling and marketing practices, especially for products sold in California.

Notably, supplements often breach this law due to elevated levels of lead found in botanicals. Lead is a common contaminant in many natural ingredients used in supplements, and if its concentration exceeds the safe harbor levels set by Prop 65, warnings must be provided. Failing to do so can result in substantial legal and financial repercussions, including fines and lawsuits.

For brands selling supplements online, compliance with Prop 65 is non-negotiable. Despite a physical location in places like New York or Colorado, online sales inherently include California consumers. This means that brands can be held accountable under Prop 65, leaving them vulnerable to legal action from California-based law firms.

To avoid these risks, it is crucial for supplement brands to ask their manufacturers to calculate lead exposure levels for every production lot. This proactive measure ensures that products meet the safety standards required by Prop 65, helping to protect the brand from potential legal challenges and maintain consumer trust. By prioritizing compliance, brands can safeguard their reputation and demonstrate a commitment to consumer safety and transparency.

In our experience manufacturers receive either boosted or wrong species or wrong plant parts in botanical powders about 30% of the time. This risk is higher when manufacturers are not known to provide feedback as to the identity of botanicals to importers of those products. The risk goes down once bulk suppliers know that the factory runs an ID test 100% of the time.

Less scrupulous suppliers might add inexpensive ingredients like rutin, buckwheat, or other fillers to bulk up herbal products and increase their weight or volume, potentially to make more money. This practice can dilute the potency of the primary herb and mislead consumers about the product’s true content. It’s crucial for brands to work with reputable suppliers who provide transparent ingredient sourcing and rigorous quality control to ensure the integrity and efficacy of their herbal products. Regular testing and verification can help maintain product quality and consumer trust.

In some cases, it might be more prevalent in lower-cost products where margins are tight, and suppliers might be tempted to cut corners.