Arsenic, Cadmium, Lead, and Mercury…Why Should You Care?

Heavy metals—What are they and why should you be concerned about them? The elements known as heavy metals include arsenic, cadmium, lead and mercury. These elements can be present in the soil that your materials are grown in or found in facilities where your products are produced. These contaminates can pose a health risk to your consumers and could even cause poisoning if they are consumed in high enough quantities. Due to their high health risk, the FDA requires testing for these analytes to be compliant with their GMP regulations. You may be asking yourself some questions regarding this testing and SORA Labs is here to answer them! Some of the most commonly asked questions and their responses are below:

Q: What stage of manufacturing can you test for heavy metals?

o   Raw Material

§  When you test your raw materials, you are more likely to catch a “bad” ingredient before you add it to your blend and ruin your entire batch. 

o   Finished Products:

§  Finished product testing confirms that the product meets required standards once all ingredients are blended and no heavy metal contamination occurred during the manufacturing process.

Q: Why Choose the ICP-MS method?

§  There are other methods that can be utilized for heavy metals analysis, however, ICP-MS allows the laboratory to achieve lower detection limits when compared to ICP-OES. This lowered detection limit allows for more accurate and precise data on your product.

§  Prop 65 requires certain limits of heavy metals to be met. Some prop 65 results can be obtained by ICP-OES; however, the serving size becomes a large factor. By using ICP-MS the factor of serving sizes becomes less of a deterrent. We are now able to achieve prop 65 levels on a larger variety of serving sizes.

If you have any remaining questions, please do not hesitate to contact us. SORA Labs would love to assist you with making sure your consumers are getting a top quality product! We offer ICP-MS heavy metal and mineral testing along with many other assays, ID and contaminate testing needed in the dietary supplement industry.  Visit our website today!

In the wake of the CBC retraction of the November 2015 dietary supplement report due to testing inaccuracy, questions are being asked about the function and processes of third party laboratory testing. With so many different labs offering testing, how is one to know if the accepted practices are being followed? What makes a lab trustworthy in their methods? What could have happened that caused the tests to go wrong?

 

What is required of a lab to receive their accreditation? There are many factors that go into receiving an ISO 17025 accreditation. These are just a few examples of some practices that must be followed for a lab to be accredited:

 

For a lab to be ISO 17025 accredited, they are required to do proficiency testing, which means testing the same sample by multiple analysts, preferably between different labs and comparing the RSD% (Relative Standard Deviation) of the results. There are tight ranges for these results that show proficiency.

 

ISO 17025 accreditation is specific to certain lab tests and not all tests that a lab runs are within their ISO 17025 scope of accreditation. The ISO 17025 certificate for each lab lists the accredited tests. This accreditation is considered to be the lab’s expertise.

 

The Preventive/Corrective Action system (PCAR or CAPA) is used for any lab issue to improve all company practices. ISO 17025 accreditation requires continual improvement, so when a lab error is found, a PCAR is then generated to solve the problem for future testing.

 

Out of Specification (OOS) results require a lab investigation as part of the ISO 17025 guidelines and Good Lab Practices (GLP). Each lab is responsible for accuracy, so when results are out-of-spec, the lab will double-check many things including: sample handling practices; reagent expiration dates; if equipment calibration is up-to-date; dilution factors; and testing calculations. In addition, the lab should verify that the method was followed as written and if it was valid for the sample matrix. Along with other considerations, it is important to ask if the sample appeared to go fully into the solution? If a lab error is found, retesting and retraining should be conducted. Since this investigation takes additional time, samples that are OOS will be delayed due to this process.

 

 

What steps should a lab take to make sure that their results are accurate? What are some suggestions for avoiding mistakes?

 

SORA double-checks the results of each testing run against a known "known or reference standard." For enzyme activity assays, this standard is just an extra sample of "known value" included the run to ensure that it is being performed according to procedural guidelines. This result is recorded and the RSD% is calculated. The result must fall within a range set by the validating method for the entire run. If the known or reference standard falls outside of the given range, the run is considered invalid and all results are thrown out—invalid results are not reported to the customer.

 

Labs should follow the practice of validating the method on a new sample matrix. This can be a long expensive process, with testing often expected on a fast turn-around time, so this process is rarely done. A quick check for method performance can be done on the new sample matrix using "spike recovery" testing. Spike recovery testing involves adding a known amount of the chemical you are looking for in the sample matrix and then seeing what your method recovers on the matrix. The results can help you decide if the method will work on the new sample matrix.

 

Issues can also occur during testing if the wrong method was used to run the sample. There may be several potential methods of testing for the same compound so it is always a best practice to ensure that the correct testing method is being used before beginning.

 

As Stuart Phillips, a scientist at McMaster University who studies the effects of protein supplements on humans, says: "Like anything else in life, I think when a lab gets something wrong, [it can happen for a number of reasons like] human error, contaminated dirty glassware, [or] machine malfunction." Though things could potentially go wrong, taking the proper precautions and following the accredited procedures will help keep mistakes to a minimum and help ensure correct testing results.

 

 

How do you choose a testing method?

Recently, news about dietary supplements being pulled from the shelves of New York chain stores, has left supplement users questioning product safety and quality.  And while there are many quality manufacturers and ingredient suppliers, it’s imperative that solid testing procedures are in place for every product.

Are you testing your nutritional ingredients and dietary supplement products?

Testing is required under the Code of Federal Regulations.  CFR, 111.75(c)(1) states, “you must select one or more established specifications for identity, purity, strength, composition” then CFR 111.75 (2) states, “you must conduct appropriate tests or examinations to determine compliance with the specifications selected.”

SORA Labs is here to help!  We want to be your testing lab!

We are an ISO 9001:2008 certified and ISO 17025:2005 accredited testing lab. The International Organization of Standardization holds companies, like ours, to the highest level of quality. Each year these independent auditors review our processes and procedures to ensure that our customers are receiving accurate, reliable, quality CoA results. We are continually growing; investing in the latest equipment; and adding capabilities to better serve our customers. We want to be your partner in quality. Let us be your best asset!

How do you choose a testing method?

There are many reliable and validated testing methods to choose from. Organizations like the USP, FCC, AOAC, as well as many peer-reviewed journals have published validated methods for testing ingredients and nutritional products.

Selecting a validated or peer-review method is extremely important. When purchasing an ingredient, it is critical to ask the supplier what method they used to identify, assay, or qualify their ingredient. Additionally, this will also provide information about the ingredient and how the supply has been verified.

Testing will prove the quality and purity of the ingredient and finished products. Working together, we can keep quality products on the store shelves!