Are You Testing Your Raw Ingredients?

In recent years, the FDA and other governing bodies have been tightening regulations for dietary supplement companies. Seen in the recent attacks by the NY attorney general and other agencies, they have criticized companies for mislabeling ingredients. It was unfortunate for the companies on the receiving end of these attacks because the agencies used non-traditional testing methods, which have not been proven to be effective at identifying the purity of raw ingredients. As a result, these companies faced loss of consumer trust in their products and it undoubtedly affected their bottom line. So how can you protect your company from events like this? Testing your raw ingredients is the best way to address this concern!

According to 21 CFR 111.120, companies are required to determine whether all components, packaging, and labels conform to specifications that are established in 21 CFR 111.70 (b) and (d).  These specifications are provided for each component (raw ingredient) that is used and must be established as follows:

                (b)

1.       You must establish an identity specification.

2.       You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met.

3.        You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(d)

You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

 

If you pay close attention to (b) you can see how the testing of your raw ingredients is mandatory. The minimum requirement is for ID, purity and strength to ensure your raw ingredients are what you are claiming. This documentation is also very important when you test your finished product and notice matrix interference occurring after testing has been completed. Matrix interference can cause certain analytes to be much higher or much lower than your anticipated label claim. When you have documentation of the quality of your raw ingredients, it allows for a written documentation detailing the unexpected results for reference if your product is ever under scrutiny.

Probiotic Testing Information

For the last couple of months our focus has been on the bad “bugs” that could be present in your supplements. However, not all bugs are bad! Probiotics are the good “bugs” that could be your consumer’s best friend. Probiotics occur naturally in our body, but certain factors such as antibiotics, stress, poor diet, and even aging can diminish their presence and our body. When this decrease occurs our bodies need a bit of a boost to keep a healthy balance. You may find yourself asking why these little organisms living in mainly our intestines are so important to our bodies. This is because they enhance the intestines’ barrier function, compete with and suppress pathogenic bacteria, and modulates and stimulates immune system activity.¹ So, when your consumers turn to your product to help provide the much needed probiotic boost are they receiving the product they think they are?

When you begin the discussion of probiotic testing, it can be a very worrisome topic; however, SORA Labs is here to help you out! Many probiotic testing methods are very vendor specific. This means that where and who you purchase your probiotic raw materials from is a major deciding factor as to how they are tested. Due to the many strains and their unique characteristics, there is not a single method that will provide an accurate, true representation of the enumeration of multiple strains in a finished product. Once they are blended together, you can try testing each strain by the method most suitable for it; however, some overlap may occur providing inaccurate numbers.  Therefore, SORA Labs recommends the testing of single strain raw ingredients to ensure that you are putting what you think you are into your products. SORA Labs has the capabilities of performing many of the vendor methods and we are always expanding our testing capabilities. If you have a probiotic product that needs to be tested, please feel free to contact us!

Reference:

1: Fedorak RN, Madsen KL. Probiotics and the management of inflammatory bowel disease. Inflamm Bowel Dis. 2004 May;10(3):286-99. VIA http://www.lifeextension.com/magazine/2009/1/optimize-digestive-health/page-01

2: http://www.webmd.com/digestive-disorders/features/what-are-probiotics

Let SORA Labs test your ingredients for Pesticides, Microbial counts or even Probiotic Enumeration!

SORA Labs Would Love To Be Your Team Of Investigators!

We still have open appointments for Supply Side West in Las Vegas, Oct. 5-8! Schedule your appointment now to learn how SORA Labs will be able to help ensure the quality of your products. Call Tammy at 417-251-3870 email: tblakemore@soralabs.com or Rashel at 417-545-0363 email: rpack@soralabs.com. We have Breakfast, Lunch, Dinner, and Booth appointments available!

SORA Labs will be attending Supply Side West in Las Vegas, NV October 5-8th. Find out how SORA Labs can be your team of investigators that ensure the safety and quality of your products. Reserve your Dinner or Booth Appointment today by contacting Tammy Blakemore at tblakemore@soralabs.com phone: 417-251-3870 or Rashel Pack at rpack@soralabs.com phone: 417-545-0363. We look forward to hearing from you!

Vendor Qualification

I just had an article published about Vendor Qualification.
It is here on the INSIDER site.

http://www.naturalproductsinsider.com/authors/tammy-blakemore.aspx

Let me know if you have any questions.
Thanks!

Tammy Blakemore or Rashel Pack

SORA Labs

15366 US Hwy 160

Forsyth, MO  65653

Office:  417-546-8075

Cell:  417-251-3870

Toll Free:  877-645-8767

TBlakemore@SORALabs.com

RPack@SORALabs.com

Are my ingredients irradiated?

We want to be your supplement testing lab!

www.SORALabs.com

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!