Ingredient adulteration—what you need to know now!

By definition, adulteration means, “to make impure by adding extraneous, improper or inferior ingredients.” The FDA/USDA considers “adulteration a legal term if a food product fails to meet federal or state standards. This usually refers to noncompliance with health and safety standards as determined in the US, by the FDA and the USDA.”
In a recent FDA warning letter to TerraVare, Inc., dated 7/12/16, the FDA stated: “These violations cause your High Frequency Super Food Formula dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements.”
Adulteration can happen in many forms. One example is adulteration with illegal or tainted substances. Other issues may include heavy metal contamination; high level microbiological counts; and residues like pesticides or solvents. Testing is the key to knowing exactly what is in your products, although not every adulterant can easily be found. However, if you are testing for known contamination and adulteration potentials, this is a great place to start finding any problems.
Case in point—in 2013, an enzyme recall occurred after chloramphenicol, an antibiotic drug residue, was found in digestive enzyme products. No one would have ever expected an adulterant or illegal substance in this type of product. As a result, many enzyme manufacturers now screen incoming raw materials for chloramphenicol, as it’s now considered an adulterant to watch for in these types of products. Subsequentially, testing for chloramphenicol residue in enzymes is now a normal quality check, performed routinely in our lab.
When choosing what testing is needed for your materials, you must evaluate the product for known contamination risks. Since botanical or herbal ingredients are grown outside, potentially coming in contact with pesticides for insect control, a pesticide residue screen would be able to verify that the botanical is clean and free from any pesticide residue. For botanicals labeled organic, this is even more critical, as unintended contamination from pesticide runoff in other fields could have occurred. The pesticide residue must be monitored to ensure that the material would not be considered adulterated
Plant material and anything grown in the soil, is also susceptible to higher heavy metal and microbiological counts in countries with crude waste disposal or poor water quality. Botanical ingredients must be tested to ensure that they are safe for human consumption. Also, since microbiologic counts could be high in botanical materials, processors may use irradiation treatments to help lower the bacterial counts. In many countries, including the US, materials that have been irradiated must be labeled as such. USP <2250> Pulsed Photo Simulated Luminescence (PPSL) was added to the USP in 2015 as a testing method to detect irradiation of ingredients. Testing to determine if your material has been irradiated will allow you to label your finished product correctly.
Adulteration of products is serious business, as many high-profile supplements have been abruptly yanked off the shelves by the FDA because they included illegal ingredients. It is imperative to make sure your product matches your label claims and is free of any unintended ingredients. Your quality team will be tasked with deciding what testing is needed for each material that will be used in manufacturing, and knowing who to call for your testing needs is paramount. Just know, SORA Labs is always here to help with testing any of your testing needs—let us be an extension of your quality team!
 
 
 
 
 

Why we soar above the rest!

Don’t use an imitation—use the original. Experience counts!

Our lab qualifications:
We are one of the only labs with enzyme assays on our ISO 17025:2005 Scope of Accreditation. This means we:

  • Have a stringent proficiency testing program in place. We want to ensure that our testing is accurate, reliable and repeatable.
  • Use Reference or Check Standards with each method we run. The test results must be within a certain RSD% for the run to be reported. Not all testing labs use standards. See our blog for additional information on what mistakes your testing lab may be making.
  • Have been chosen as a testing lab for the U.S. Pharmacopeia to verify some of the reference standards that they sell. Our reputation and quality testing are used by the top of the industry.
  • Run enzyme assays every day, as this is a large volume of our business. With 25+ years of experience , these USP enzyme methods are long and tedious and have been perfected over time. Unlike HPLC methods that can easily be adapted to any lab, these are more complicated wet chemistry reactions to measure the activity of the enzyme, not just the amount used in the product. Read more here.
  • Focus on customer service and partnership with your company. We want to be here for the long term, not just one sample. We gladly communicate about the results or answer any questions that you have about your
  • Have annual ISO external audits and also conduct annual ISO internal audits. We strive for continual improvement and perform preventive and corrective actions.

Top Quality Testing=Top Quality Products

 

SORA Labs expands Quality Control team

Forsyth, MO—SORA Labs recently welcomed Quality Supervisor, David Gauwitz to their accomplished QC team. David brings nearly 35 years of proven, award-winning experience to further enhance the level of excellence that SORA is known for. As Quality Supervisor, David will be working on the continual improvement of ISO process management while supporting the lab to meet the highest quality standards.
Leading the quality team is Lab/Quality Manager, Bob Williams and Technical Manager, Ramona Clemens.  Ensuring accurate results takes continual verification of generated data. As the lab continues to grow, calibrations and data testing, along with “Out of Specification” investigations and analysis, become a larger undertaking to maintain the same high quality standards.  David will further enhance SORA’s ability to meet customer deadlines, along with ensuring every piece of the quality control process fits together.
Known for its consistently accurate and precise results, SORA Labs has a quality system in place that will withstand even the toughest scrutiny.  SORA Laboratories is registered with two different internationally recognized ISO standards: an ISO 9001:2008 certification and ISO 17025:2005 accreditation. These standards represent quality, accurate testing, designed to give customers peace of mind.
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For over 20 years, SORA Labs has been specializing in enzyme assays, probiotic testing, nutraceutical and agricultural testing methodology, along with being the foremost expert in testing for quality and potency in natural ingredients, raw materials and finished products.  SORA Labs has dedicated itself to perfecting methodologies, performing analytical tests and developing procedures to be a one-of-a-kind testing facility.  For more information, visit soralabs.com.

Probiotic testing challenges—the right lab makes all the difference!

Probiotic testing can be complicated. Here’s why—most of the testing methods available are for single strain raw materials. Additionally, many methods come from the manufacturer and are specific to their material. And if that didn’t create enough confusion about what testing was appropriate, the Food Chemical Codex (FCC) has also added several probiotic monographs. These monographs have procedures for identification, enumeration assays and specific Whew! So how can you decide which testing method to use—the answer lies within using a lab that is experienced in probiotics.
An experienced lab like SORA, will know that the identification portion of the FCC monograph is for nucleic acid-based identification using PCR or other genetic identification methods. The assay portion of the monograph uses various growth media and specific aerobic or anaerobic conditions for optimal growth of the probiotic strain. The specific test section will have testing recommendations for that particular strain of probiotic.
Since these procedures require specialized equipment, and specific agars and broths to perform the testing, this can be challenging due to the high growth counts of this material. Typically in a microbiology lab, the samples being tested have very low plate counts, but with probiotic material, high counts in the millions or even billions of cfu/g are expected. Lab contamination is also a concern when working with probiotics, so proper sample handling is very important to ensure that the testing environment and air quality stays clean. Because of these challenges, working with probiotics in a separate section of the lab and at separate plating times is often required to avoid microbiology contamination of other samples in the testing lab.
While finding the best assay method may be difficult when working with blended probiotic strain products, reviewing the individual strain methods and looking for overlapping testing is generally a good starting point. And, since there may not be one “ideal” method, the testing lab may need to attempt several probiotic methods and perform method development before exact testing can be determined for the specific product.
With so many challenges, it may seem daunting to make sure your product is being properly tested! However, choosing a lab that is accustomed to handling probiotic material and performing specialized testing such as SORA Labs, can take the stress out of making sure your product meets label claims—choose wisely.

What mistakes is your testing lab making?

Is your lab using reference standards when performing testing? We’ve found that not all labs do this—in fact, we tested against one lab recently that was not using a reference standard with their FIP Lipase method. What a mistake! Without a reference standard, how do you know if your method is working appropriately and providing accurate results for the unknown sample? You don’t! Purchasing reference standards and performing proficiency testing gives a lab credibility and is an investment in quality—which as a testing customer, you should expect.
Another big mistake is not using positive and negative controls when performing microbiology We have spoken to several labs that do not test each method using a negative control, which is compared to a positive control test. While these microbiology quality control pellets are expensive, they are highly beneficial for accurate results—it’s unfortunate that some labs do not fully understand the benefit. SORA performs a positive and a negative control test with each microbiology method daily. These test results prove that our method is working that day.
Throughout the year SORA participates in microbiology and chemistry proficiency testing studies. We perform various methods on identical samples, testing against other labs or peer groups. These results are statistically calculated to determine our proficiency with the method tested. Proficiency testing builds confidence with the lab technicians and customers and demonstrates that the method is being performed accurately. Is your testing lab doing this?
And while this is just a couple of ways a testing laboratory can invest in quality control, these steps pave the way for accurate results. There’s a reason that some labs charge unusually low prices—and it’s a good idea to ask questions before purchasing services that may not provide you with the most accurate results. Ask about reference standards, microbiology controls and proficiency Are they actually spending the time and money required to give accurate results? If not, go elsewhere! “Quality means doing it right when no one is looking”—Henry Ford.

Need an extra hand…or two?

Ever felt like you could use an extra hand or just needed an extra team member who could provide specialty services that you desperately need from time to time? SORA Labs wants to be a valuable extension of your quality control department. How can we do this for your team? By providing fast, reliable testing services that are available when you need them.
The FDA CFR 111 requires that a manufacturer establish product specifications for identity, purity, strength and composition for the limits of those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. To prove that the material is within specification, testing must be conducted.
Identity testing is the first step in verifying that you have the correct ingredient in your product.
Using compendia like the USP, FCC, BP or organizations that provide validated methods like the AOAC or ACS is a great place to start when determining your testing needs. Also, using reference standards to verify ingredient identity is also invaluable. The USP, for example, offers many testing recommendations such as:

  • Gelatin testing- ID-A and ID-B are listed for standard gelatin and ID-C is listed for non-gelling ID. The USP lists specific tests and contamination testing recommendations for microbial and heavy metals.
  • Ginkgo Extract- TLC ID and HPLC retention time peaks are listed for identification. Composition testing is for the active marker assays including Flavonol Glycosides and Terpene Lactones. The contaminate testing includes pesticides, residual solvents and microbial limits
  • Wheat Bran- Microscopy is listed as the ID. Composition testing includes the amount of total dietary fiber and contaminate testing shows insect infestation and microbial limits.
  • Biotin shows ID-A as FTIR; ID-B is Optical Rotation; and ID-C is HPLC retention time peaks. The assay uses HPLC and measures the active marker of Biotin.
  • Papain is determined by a wet chemistry enzyme activity reaction with a UV-Vis end-point. There are some specific tests listed and the USP reference standard is noted.

Based on the wide variety of testing recommendations for just these few ingredients, it’s easy to understand the amount of equipment and expertise it takes to effectively test these products. Since setting up an analytical and microbiology testing lab requires a large capital investment and, for some companies, may be cost prohibitive, this is an excellent reason to use a quality third-party lab, such as SORA Labs. This gives us the opportunity to be that extra bit of help when you need it the most.
Another reason to use a qualified and accredited testing lab is to help avoid FDA warning letters like this recent one addressed to Pacific Nutritional. On April 15, 2016, the FDA wrote “Once you have established finished product specifications, you must verify that the specifications are met, as required by 21 CFR 111.75(c), and you must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). In addition, you must make and keep records in accordance with 21 CFR 111.95(b).”
From testing the initial raw material to the completed finished goods, SORA is here to help. As an ISO 9001:2008 certified and ISO 17025:2005 accredited testing lab, let us be a valuable part of your quality team!