Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, April 15, 2016

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!



Sunday, February 8, 2015

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!