At LifeVantage, we are overachievers. We provide the best products from the best company to the best people. Today we talk about the manufacturing process and how it is that we bring you products that not only meet the standards, but exceed them!
The U.S. Food and Drug Administration (FDA) regulates both finished dietary supplement products and dietary ingredients under the Dietary Supplement Health Education Act (DSHEA). This is a different set of regulations than those covering “conventional” foods and medicinal products.
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. This means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
When it comes to dietary supplement manufacturing, there are requirements that a manufacturer must follow in order to comply with industry regulations. Some of these requirements are the same as those used in the pharmaceutical industry, including multiple verifications and signoffs during production. At LifeVantage, in addition to those standards, we conduct additional testing, auditing, and reporting in order to provide you with the highest quality products.
Testing Finished Goods
The FDA requires manufacturers to perform the following tests on finished goods:
- Microbiological contaminants
In addition to those required by the FDA, LifeVantage goes further and performs the following tests:
- Heavy metals
- Pesticides and herbicides
- Banned substances
After products have been manufactured, tested, and shipped to us by our suppliers, we use a third-party lab to test and verify that every batch of product meets our strict quality standards. Our testing takes place in a clean, laboratory environment following standard Good Laboratory Practices (GLPs) in order to avoid any potential environmental contamination.
As part of the dietary supplement regulations, the FDA allows for “subset testing” (testing a representative number of samples), usually one in every five or ten lots of material received or produced. In developing a subset testing plan, a manufacturer uses statistical sampling to determine the amount of samples necessary to approximate the quality of the product.
While subset testing may save an immense amount of time and money, here at LifeVantage we’re more interested in quality, than quantity – so we don’t perform subset testing. We want to ensure that everything we produce is of the highest quality.
So we test every lot of every product.
We refuse to use or sell products that do not meet our distributors standards.
Auditing Foreign Suppliers
The industry standard for auditing foreign suppliers is generally known as the “one up, one down” system. Manufacturers must know the safety information of who is supplying their materials (one down), and must also know who they supply materials to (one up). The industry standard follows three requirements (below).
We improve upon these three requirements using a “total supply chain management” system to verify where every lot of raw material comes from and where we send our products.
|FDA Minimum Requirement||LifeVantage Standards|
|The FDA requires a company to know who their supplier is and to verify through testing that the materials they receive meet established specifications. A physical audit of suppliers is not required. Instead, manufacturers can rely on subset testing of the material and a Certificate of Analysis (C of A) which is “proof” that all materials meet specifications.||Improving upon the FDA requirements, LifeVantage physically audits domestic and international raw material suppliers and manufacturers. LifeVantage also performs thorough testing (as noted above) to verify the information on the Certificate of Analysis (C of A) and ensure that every lot of material meets quality specifications.|
|The FDA requires a company to know exactly who products were sent to in case of a recall.||The LifeVantage total supply chain management system tracks all lots of finished product, who received them, and exactly what lots of raw materials were used in the production of each lot. Our system provides complete traceability from beginning to end.|
|The FDA requires a company to audit supply and manufacturing companies that they do immediate business with.||LifeVantage audits the entire supply chain: immediate partners, contract manufacturers, U.S. distributors of raw materials, international raw material manufacturers, and warehousing/fulfillment companies.|
Assuring No Foreign Matter
We want to assure that all aspects of our production are accounted for. That’s why we use a total supply chain management system; to verify exactly what is being produced and how it is getting to you.
To ensure that no foreign material enters the manufacturing process, raw material manufacturers pass the material through mesh screens and magnets prior to packaging. These two processes help to ensure that no foreign matter enters the product.
LifeVantage improves upon these practices by including additional procedures during the manufacturing process. LifeVantage audits our raw material suppliers and contract manufacturers to assure that:
- Raw materials pass through metal detection, magnets and fine mesh screens to prevent any potential contaminants.
- Tablets and capsules pass through metal detection immediately after being pressed into tablets or filled into capsules.
- Finished product passes through metal detection after packaging.
Our additional procedures ensure that no foreign materials have inadvertently entered the materials or production process. These additional measures implemented by LifeVantage provide you with the safest, most effective products possible.
Reporting Adverse Events
In the dietary supplement industry, the FDA mandates that we collect all health complaints and report all serious health complaints to the FDA through the MedWatch system. LifeVantage meets this requirement by partnering with SafetyCall, the “world’s largest 24/7 Adverse Event Call Center.” SafetyCall receives and reviews all of our health complaints, helps to evaluate and monitor trends, and provides assistance for complaints that require reporting to the FDA. This allows us to actively address any problems that arise.
LifeVantage has one of the most comprehensive quality assurance systems in the industry. LifeVantage is a pioneer in QA (quality assurance) to the point that other companies are now requesting the same level of quality from their manufacturers and suppliers. We are proud of what we’re doing to help raise industry standards and provide to you the safest, most effective products on the market.
* The views expressed in this article are those of the author
s and do not necessarily reflect the official policy or position of LifeVantage or any other agency, organization, employer or company
** LifeVantage’s Marketing team may from time to time publish blog articles reporting information and research from third-party sources. The views and opinions expressed by these third-party sources as reported in LifeVantage blog articles are those of the authors and experts quoted therein and do not necessarily reflect the official policy or position of LifeVantage.