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The analytical testing requirements for the safety, identity, and potency of dietary supplements vary depending on the specific product and ingredient composition. Here are the general requirements:

• Safety Testing: Dietary supplement manufacturers and distributors are responsible for ensuring that their products are safe for consumption. This can include toxicological testing, microbiological testing, and heavy metal testing to ensure that the product does not contain harmful substances.
• Identity Testing: Identity testing is performed to confirm that the ingredients listed on the label are what your supplier says they are. This is the minimum test requirement that must be conducted on all dietary supplement products. This can include tests such as high-performance thin layer chromatography (HPTLC), enzyme-linked immunosorbent assay (ELISA), Fourier transform infrared spectroscopy (FTIR), and many more.
• Potency Testing: Potency testing is performed to confirm that the product contains the claimed amount of active ingredients. This can include tests such as HPLC, ICP-MS, and gas chromatography-mass spectrometry (GC-MS).

It’s important to note that the FDA does not currently have specific analytical testing requirements for dietary supplements, but companies are expected to establish their own specifications per product and dietary ingredient with respective quality parameters and testing methods. Companies are also expected to follow good manufacturing practices (GMPs) and to ensure that their products are safe, accurately labeled, and of high quality. Companies can partner with FC&T for all of their testing needs to validate the quality and safety of their products.

Dietary ingredient testing refers to the evaluation of raw materials used in the manufacture of finished products to determine the identity, purity, potency, and composition of the ingredients. The purpose of dietary ingredient testing is to validate supplier-provided certifications and ensure that the raw materials meet the required quality standards prior to use in the manufacturing of dietary supplements.

The testing typically involves a combination of analytical methods that may be unique to the dietary ingredient. The tests can be used to determine the presence of contaminants, potential adulterants, heavy metals, allergens, microorganisms, identity, and potency of the ingredient.

It is important for dietary supplement manufacturers to conduct regular testing on their ingredients to ensure that they meet all the necessary regulatory requirements and to provide consumers with safe and high-quality products.

Potency testing refers to the process of determining the purity or the amount of active ingredient(s) of a product or raw material. This testing is performed to validate the materials from a supplier or ensure that a product meets label claim.

Potency testing typically involves the use of analytical techniques such as atomic absorption spectroscopy, inductively coupled plasma mass spectrometry (ICP-MS), and high-performance liquid chromatography (HPLC). The chosen method depends on the specific active ingredient being tested, the physical properties of the material (powder, liquid, etc.), and the specification of the ingredient or product.

The process of potency testing typically involves the following steps:

1. Sample preparation: This involves collecting a representative sample of the material and preparing it for analysis.
2. Method selection: This involves choosing the appropriate analytical technique for measuring the potency of the material.
3. Method validation: This involves verifying the accuracy and reliability of the analytical method by comparing the results of the analysis to known standards. The method must be validated to ensure that it provides consistent, reliable results.
4. Analysis: This involves running the sample through the analytical method and determining the concentration of the specific active ingredient.
5. Comparison to purity or label claim: The results of the analysis are compared to the purity or label claim to determine if the dietary ingredient or product meets the stated amount of content.

Potency testing helps to build consumer trust and confidence in the product, protect the company during regulatory audits, protect the company from unreliable suppliers, and helps to validate that the product is effective.

Identification testing is the process of verifying the identity of the specific raw material or active ingredient(s) in a product. This type of testing is important for ensuring that the raw material is of the correct origin or the product contains the correct ingredients that are listed on the label.

Identification testing typically involves collecting a sample of the product and analyzing it using techniques such as high-performance thin layer chromatography (HPTLC), spectroscopy (IR, NMR, UV), and mass spectrometry (MS). These techniques can be used to identify the specific compounds in the product or material and to verify their identity.

The results of identification testing can provide important information about the quality and accuracy of the labeling of a raw material or product. If the test results indicate that the material does not contain the ingredient(s) that are listed, it may be misbranded and may not be suitable for use in manufacture or consumption.

Microbiological testing is the process of testing for the presence of harmful microorganisms such as bacteria, pathogens, yeast, and mold in the product. This type of testing is important for ensuring the safety and quality of dietary supplements, as the presence of harmful microorganisms can cause foodborne illness or other health problems.

Microbiological testing typically involves collecting a sample of the product and analyzing it for the presence of specific microorganisms using methods such as culture-based techniques, polymerase chain reaction (PCR), and other molecular methods.

The results of microbiological testing can provide important information about the safety and quality of a dietary supplement. If the test results indicate the presence of harmful microorganisms, it may indicate that the product has been contaminated and may not be suitable for consumption.

Heavy metals testing is the process of testing for the presence of heavy metals such as lead, mercury, cadmium, and arsenic in the product. This type of testing is important for ensuring the safety of products, as exposure to heavy metals can cause serious health problems.

Heavy metals testing typically involves collecting a sample of the product and analyzing it for the presence and potency of specific heavy metals using methods such as inductively coupled plasma-mass spectrometry (ICP-MS), atomic absorption spectrometry (AAS), and other analytical techniques.

The results of heavy metals testing can provide important information about the safety of a product. If the test results indicate the presence of high levels of heavy metals, it may indicate that the product has been contaminated and may not be suitable for consumption.

The US Food and Drug Administration (FDA) recognizes nine major food allergens, which are responsible for most food allergies in the US. These allergens are:

• Milk
• Eggs
• Fish (such as bass, cod, flounder, and others)
• Crustacean shellfish (such as crab, lobster, and shrimp)
• Tree nuts (such as almonds, pecans, and walnuts)
• Peanuts
• Wheat
• Soybeans
• Sesame

The FDA requires that these allergens be declared on food and supplement labels if they are present in the product, either as an ingredient or as a result of cross-contact during processing. The declaration of these allergens on food and supplement labels, helps to protect consumers who are sensitive to these allergens and to provide them with the information they need to make informed decisions about the products they consume.

If you need assistance navigating these regulations, or have a facility that handles any of the allergenic ingredients above (including gluten) and require certified environmental or product testing, partner with FC&T. Our team of experts are here to help.

Shelf life testing is the process of determining the length of time that a product can be stored without losing its potency, safety, and quality. This information is important for consumers, major distributors such as Amazon, and helps companies determine the expiration date for their products.

A finished product can be impacted during a shelf life test due to several factors such as:

• Chemical Degradation: Active ingredients can degrade over time due to chemical reactions with other ingredients, light, heat, or moisture. This can result in a loss of potency of the active ingredient(s).
• Microbial Contamination: Microorganisms such as bacteria, yeast, and mold can grow, which can cause a change in the composition of the product. This may indicate a reduction in safety of the product due to the growth of harmful substances.
• Physical Changes: Physical changes such as oxidation, discoloration, and particle size changes can also occur during a shelf life test. These changes can impact the end user experience or product stability.

The shelf life of a product can be influenced by a number of factors, including the type of ingredient(s), pH, preservative profile, water activity, storage conditions, and the packaging used. The data obtained from either real-time or accelerated testing is used to create a stability profile for the product, which can then be used to determine its shelf life.

The quality of a dietary supplement can be impacted by several factors and shelf life testing is an important part of ensuring that the product remains safe and effective. Companies can choose to undergo stability testing to demonstrate the quality and safety of their products to regulatory bodies and major distributors.

Are you looking to meet the standards set by Amazon Seller Central for your dietary supplement products? Our experts are well-versed in the latest Amazon guidelines and can assist you with all aspects of testing. We offer comprehensive testing services to prove the safety, potency, and absence of adulterants in your products.

Our testing services are designed to help you build consumer trust and confidence in your products. By demonstrating the safety and purity of your supplements, you can increase customer satisfaction and grow your business on Amazon.

Proving the absence of adulterants in sexual enhancement, weight management, weight loss, bodybuilding, and sports nutrition supplements in accordance with Amazon Seller Central guidelines involves a comprehensive testing plan. The goal of this testing is to meet Amazon’s criteria that the product is safe, pure, and free from adulterants so that it can be sold on their platform.

The process of proving the absence of adulterants typically involves several steps:

• Sample collection: This involves collecting a representative sample of the product for testing.
• Method selection: This involves choosing the appropriate analytical techniques and methodologies to test for specific adulterants. The techniques used depend on the specific product type and the list of chemicals outlined on Amazon Seller Central.
• Analysis: This involves running the sample through the analytical tests and determining the presence or absence of specific adulterants.
• Generation of COA for Comparison to Amazon guidelines: The results of the analysis are documented on a Certificate of Analysis (COA) and are compared against the guidelines set by Amazon Seller Central to determine if the product meets the standards for safety and purity.

Not all labs have the capabilities to test for each specific compound, which would require additional resources organizing unique samples and having them tested at various locations. FC&T is proud to offer a one-stop solution as we are able to provide certified testing to meet all of your needs.

Contact us for a free initial consultation now and take the first step towards ensuring the success of your products on Amazon. Let us help you meet the rigorous standards set by Amazon and grow your business with confidence.

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California law that requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm. If you need assistance navigating these regulations or require certified heavy metals testing, partner with FC&T. Our team of experts are here to help.

Proposition 65 requires that products sold in California not contain heavy metals, such as lead, mercury, cadmium, and arsenic, at levels that exceed the maximum allowable limits set by the law. To ensure compliance with Proposition 65, manufacturers and distributors of dietary supplements must test their products for heavy metals and ensure that the levels of these substances are within the limits.

The testing process typically involves collecting a representative sample of the product, selecting an appropriate analytical method, analyzing the sample to determine the levels of heavy metals, and comparing the results to the Proposition 65 limits.

The specific heavy metals and the maximum allowable limits can vary, it is the responsibility of the manufacturer or distributor to stay informed of the current requirements and perform regular testing to ensure compliance.

By performing regular testing for heavy metals and ensuring that their products are in compliance with Proposition 65, manufacturers and distributors of dietary supplements can protect the health of their customers, maintain distribution channels throughout the country, and avoid costly fines and legal action.

Probiotic enumeration testing is the process of counting the number of live and active probiotic bacteria in a dietary ingredient or product. This testing is important to determine the potency of a probiotic and to ensure that it contains the specified amount of probiotic bacteria. The following are some common methods used for probiotic enumeration testing:

• Plate Counting: This method involves spreading a sample of the probiotic product onto a growth medium and counting the number of colonies that form. This method is simple and inexpensive, but it can be time-consuming and is not suitable for probiotic strains that are slow-growing or difficult to culture.
• Flow Cytometry: This method uses laser light and fluid dynamics to count individual cells. It is a fast and precise method that can accurately count even rare and slow-growing probiotic strains.
• PCR: This method uses polymerase chain reaction (PCR) to detect the presence of specific probiotic strains in a sample. It is a highly sensitive and specific method that can accurately quantify the number of probiotic bacteria in a sample.
• Turbidimetry: This method uses changes in the optical density of a solution to determine the number of bacteria present. It is a fast and simple method that is suitable for large-scale probiotic testing.

If you need assistance with probiotic product formulations or require certified dietary ingredient or product testing, partner with FC&T. Our team of experts are here to help.

Water quality testing is an essential step in manufacturing to ensure that the water used in the production process is safe, pure, and free of contaminants that could harm consumers. The following are some common methods used for water quality testing and are frequently used together:

• Physical Testing: This type of testing involves measuring the physical characteristics of water, such as temperature, color, turbidity, and odor. Physical testing is a quick and simple way to determine if the water is suitable for use in the manufacture of dietary supplements.
• Chemical Testing: This type of testing involves measuring the chemical composition of water, such as pH, total hardness, and total alkalinity. Chemical testing is important to ensure that the water does not contain substances that could interfere with the production process or harm consumers.
• Microbiological Testing: This type of testing involves measuring the presence of microorganisms in water, such as bacteria, pathogens, and fungi. Microbiological testing is important to ensure that the water is free of microorganisms that could cause illness or spoilage.
• Residual Solvent Testing: This type of testing involves measuring the presence of solvents in water, such as alcohols, glycols, and ethers. Residual solvents testing is important to ensure that the water does not contain contaminants that could be harmful to consumers.

These validated testing methods are essential to ensure the safety and quality of your staff, equipment, processes, and products. Contact us today to learn more about how we can help you with water quality testing!

Environmental testing is an important step in the production process to ensure that the manufacturing environment is safe, clean, and free of contaminants that could harm the product, staff, or consumers. The following are some common methods used for environmental testing and are frequently used together:

• Microbiological Testing: This type of testing involves measuring the presence of microorganisms in the manufacturing environment, such as bacteria, viruses, and fungi. Microbiological testing is important to ensure that the environment is free of pathogens that could cause spoilage or illness.
• Particulate Testing: This type of testing involves measuring the presence of particulates in the air, such as dust and mold. Particulate testing is important to ensure that the air is clean and free of contaminants that could harm the product or consumers.
• Air-Pressure Testing: This type of testing involves measuring the presence of water, microbials, and particulates in the air-pressure system, to ensure it is free of contaminants that can harm the product or equipment.
• Surface Testing: This type of testing involves measuring the presence of contaminants on surfaces, such as work surfaces, equipment, and packaging materials.

It is also important for manufacturers to maintain good manufacturing practices (GMPs) and regularly perform environmental testing to ensure that their manufacturing environment is clean and safe. Contact us today to learn more about how we can help you with environmental testing!

Developing an analytical method to test a novel compound means creating a specific process for measuring the strength or potency of that unique raw material or active ingredient within a product. Having potency results for raw materials and active ingredients within products can be referred to during an audit or be used to bolster marketing material.

The process of developing an analytical method may require an extended amount of time and typically involves several steps:

• Sample preparation: This involves collecting a representative sample of the product and preparing it for analysis.
• Method selection: This involves choosing the appropriate analytical technique for measuring the potency of the active ingredient, such as high-performance liquid chromatography (HPLC), spectroscopy (IR, NMR, UV), and mass spectrometry (MS).
• Method validation: This involves verifying the accuracy and reliability of the analytical method by comparing the results of the analysis to known standards. The method must be validated to ensure that it provides consistent, reliable results.
• Method optimization: This involves adjusting the parameters of the analytical method to ensure that it provides the most accurate and reliable results possible.

Once the analytical method has been developed and validated, it can be used to test the potency of the compound from batch to batch, or over time to determine if its stability has changed or decreased. This information may be used to determine the shelf life of a raw material or product and to ensure that it remains safe, effective, and of high quality.

In the case of a method that fails to test a compound adequately, it is important to identify and address any limitations or shortcomings in the method. This may involve revising the method, modifying the sample preparation or instrumentation, or even seeking alternative methods.

Reviewing analytical methods involves evaluating the method to determine its accuracy, precision, and reliability in measuring the concentration of the active ingredient in a sample. This review helps to ensure that the method accurately reflects the potency of a compound and that the results are consistent and reproducible.

The development and review of an analytical method can play an important role in validating a raw material or product’s label claims that the consumer is receiving the intended dose or the product itself is safe for consumption. Are you having trouble getting reliable results? Companies can partner with FC&T for assistance in method development and review to demonstrate their dedication to the quality and safety of their products.