Questions & Answers
Why is it almost “legal” for CMOs to put magnesium stearate in products without telling brand owners?
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 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.
Why doesn't the FDA require all excipients be declared on the label?
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.
What’s BSL-2? Why is it important for brands?
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.
A laboratory should have a BSL-2 microbiology lab ON LOCATION to effectively and safely test if laboratory equipment can detect pathogens, particularly when only a small proportion, such as 1 out of 100 samples, is positive for pathogens. This setup is crucial for several reasons:
- Controlled Environment for Pathogen Testing: To confirm the functionality of detection equipment, it is necessary to inoculate a controlled sample with known pathogens. A BSL-2 lab provides the appropriate containment and safety measures required for handling such infectious agents. This ensures that the testing process is conducted under controlled conditions, minimizing the risk of contamination and ensuring accurate results.
- Safety Protocols and Containment: BSL-2 labs are equipped with safety protocols and containment measures designed to handle moderate-risk pathogens safely. These labs have specialized equipment, such as biosafety cabinets and autoclaves, and follow strict procedures to prevent accidental release or exposure. This level of containment is essential to protect lab personnel and the surrounding environment from potential exposure to harmful pathogens.
- Preventing Bacterial Spread: Without the proper containment provided by a BSL-2 lab, there is a significant risk of spreading bacteria within the facility. This can endanger lab staff and compromise the integrity of other samples and experiments. A BSL-2 lab’s design includes features like restricted access, decontamination protocols, and personal protective equipment (PPE), all of which mitigate the risk of pathogen spread.
- Regulatory Compliance and Best Practices: Operating in a BSL-2 lab aligns with regulatory standards and best practices for laboratory safety and pathogen handling. This compliance is not only a legal requirement but also a commitment to maintaining high safety and quality standards in laboratory operations.
In summary, utilizing a BSL-2 lab is imperative for safely testing laboratory equipment’s ability to detect pathogens, ensuring that any potential risks are effectively managed and contained.
Why is it important to test microbiological analytical equipment with live pathogens?
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.
A laboratory should have a BSL-2 microbiology lab ON LOCATION to effectively and safely test if laboratory equipment can detect pathogens, particularly when only a small proportion, such as 1 out of 100 samples, is positive for pathogens. This setup is crucial for several reasons:
- Controlled Environment for Pathogen Testing: To confirm the functionality of detection equipment, it is necessary to inoculate a controlled sample with known pathogens. A BSL-2 lab provides the appropriate containment and safety measures required for handling such infectious agents. This ensures that the testing process is conducted under controlled conditions, minimizing the risk of contamination and ensuring accurate results.
- Safety Protocols and Containment: BSL-2 labs are equipped with safety protocols and containment measures designed to handle moderate-risk pathogens safely. These labs have specialized equipment, such as biosafety cabinets and autoclaves, and follow strict procedures to prevent accidental release or exposure. This level of containment is essential to protect lab personnel and the surrounding environment from potential exposure to harmful pathogens.
- Preventing Bacterial Spread: Without the proper containment provided by a BSL-2 lab, there is a significant risk of spreading bacteria within the facility. This can endanger lab staff and compromise the integrity of other samples and experiments. A BSL-2 lab’s design includes features like restricted access, decontamination protocols, and personal protective equipment (PPE), all of which mitigate the risk of pathogen spread.
- Regulatory Compliance and Best Practices: Operating in a BSL-2 lab aligns with regulatory standards and best practices for laboratory safety and pathogen handling. This compliance is not only a legal requirement but also a commitment to maintaining high safety and quality standards in laboratory operations.
In summary, utilizing a BSL-2 lab is imperative for safely testing laboratory equipment’s ability to detect pathogens, ensuring that any potential risks are effectively managed and contained.
What is Prop65? Should brand owners know about it?
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.
Why is there carrageenan in some HPMC capsules?
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 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.
How often do farmers and milling companies boost botanicals?
Are bulk raw materials not mandated to be tested?
FDA 21 CFR 117
FDA 21 CFR 111 does not specifically require importers and raw material suppliers to test raw materials.
For this reason, importers of raw materials used in supplements often bypass conducting their own testing, instead relying on Certificates of Analysis (COAs) provided by overseas manufacturers. Unfortunately, these tests often employ incorrect methods or be manipulated, resulting in inaccurate or misleading results. This practice poses significant risks, as it may lead to discrepancies in the identity, purity, and potency of the raw materials, ultimately affecting the quality and safety of the final supplement products.
The reliance on potentially flawed testing methods can result in the use of contaminated or substandard materials, which can have serious health implications for consumers. Without proper verification, harmful substances may go undetected, compromising consumer safety and damaging the brand’s reputation.
Hundreds of raw materials, including popular items like turmeric, are increasingly being sold by the pound directly to consumers without adequate testing, posing significant health risks. If you are a brand owner, MAKE SURE YOUR MANUFACTURER DOES NOT USE THOSE!!! They are not tested, and could contain lead either naturally in the soil or added to enhance the color of turmeric.
The lack of thorough testing and quality assurance for bulk raw materials underscores the critical need for brandowners awareness and caution. They should make sure their manufacturers follow FDA 21 CFR 111.
- 100% of all lots of botanicals should be tested for ID on HPTLC
- Microbiological tests should be conducted
– including pathogen testing in a BSL-2 lab - Heavy metal analysis should be conducted
- Potency should be analyzed as appropriate
FDA 21 CFR 111
FDA 21 CFR 111 is a critical regulation that mandates proper testing of raw materials used in dietary supplements. This regulation requires manufacturers to verify the identity, purity, strength, and composition of their raw materials to ensure they meet specified standards. By conducting thorough testing, manufacturers can maintain the quality and safety of their products, preventing contamination and ensuring that the final product accurately reflects its labeling.
The testing requirements under 21 CFR 111 are essential for safeguarding consumer health and maintaining the integrity of dietary supplements. Compliance with this regulation helps manufacturers avoid the use of substandard or contaminated materials, reducing the risk of adverse health effects for consumers. By adhering to these standards, manufacturers not only protect consumer safety but also uphold their reputation for quality and reliability in the marketplace. Overall, 21 CFR 111 plays a vital role in ensuring that dietary supplements are safe, effective, and compliant with regulatory expectations.
What is the difference between 21 CFR 117 and 21 CFR 111? Why should a brand care about that?
FDA 21 CFR 117
FDA 21 CFR 111 does not specifically require importers and raw material suppliers to test raw materials.
For this reason, importers of raw materials used in supplements often bypass conducting their own testing, instead relying on Certificates of Analysis (COAs) provided by overseas manufacturers. Unfortunately, these tests often employ incorrect methods or be manipulated, resulting in inaccurate or misleading results. This practice poses significant risks, as it may lead to discrepancies in the identity, purity, and potency of the raw materials, ultimately affecting the quality and safety of the final supplement products.
The reliance on potentially flawed testing methods can result in the use of contaminated or substandard materials, which can have serious health implications for consumers. Without proper verification, harmful substances may go undetected, compromising consumer safety and damaging the brand’s reputation.
Hundreds of raw materials, including popular items like turmeric, are increasingly being sold by the pound directly to consumers without adequate testing, posing significant health risks. If you are a brand owner, MAKE SURE YOUR MANUFACTURER DOES NOT USE THOSE!!! They are not tested, and could contain lead either naturally in the soil or added to enhance the color of turmeric.
The lack of thorough testing and quality assurance for bulk raw materials underscores the critical need for brandowners awareness and caution. They should make sure their manufacturers follow FDA 21 CFR 111.
- 100% of all lots of botanicals should be tested for ID on HPTLC
- Microbiological tests should be conducted
– including pathogen testing in a BSL-2 lab - Heavy metal analysis should be conducted
- Potency should be analyzed as appropriate
FDA 21 CFR 111
FDA 21 CFR 111 is a critical regulation that mandates proper testing of raw materials used in dietary supplements. This regulation requires manufacturers to verify the identity, purity, strength, and composition of their raw materials to ensure they meet specified standards. By conducting thorough testing, manufacturers can maintain the quality and safety of their products, preventing contamination and ensuring that the final product accurately reflects its labeling.
The testing requirements under 21 CFR 111 are essential for safeguarding consumer health and maintaining the integrity of dietary supplements. Compliance with this regulation helps manufacturers avoid the use of substandard or contaminated materials, reducing the risk of adverse health effects for consumers. By adhering to these standards, manufacturers not only protect consumer safety but also uphold their reputation for quality and reliability in the marketplace. Overall, 21 CFR 111 plays a vital role in ensuring that dietary supplements are safe, effective, and compliant with regulatory expectations.
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