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Thursday, October 20, 2016

LifeVantage Goes Above and Beyond for Quality Assurance

Science

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At LifeVantage, we are overachievers. We provide the best products from the best company to the best people. When it comes to manufacturing our products, our goal is to exceed the minimum FDA requirements and surpass the industry norm. Read on to discover how we’ve raised the bar on the entire manufacturing process.

The U.S. Food and Drug Administration (FDA) regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under the Dietary Supplement Health Education Act (DSHEA) which 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. That 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. According to a recent Consumer Reports article, many supplement manufacturers don’t quite follow these industry regulations. At LifeVantage, we conduct additional testing, auditing, and reporting in order to provide you with the highest quality products.

Testing Raw Materials and Finished Goods

The FDA requires manufacturers to perform the following tests on raw materials and finished goods:

  1. Identity
  2. Microbiological contaminants
  3. Potency

In addition to those required by the FDA, LifeVantage goes further and performs the following tests:

  1. Heavy metals
  2. Pesticides and herbicides
  3. Banned substances

After the raw material has been manufactured and shipped to us by our suppliers, we use a third-party lab to test and verify that all purchased raw materials meet 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 about 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 material or product.

At LifeVantage, we do not perform subset testing. We want to ensure that everything we produce is of the highest quality. We test every lot of active raw material botanicals that go into each finished bottle of Protandim. We will not use or sell any material or product that does not meet our high quality 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 all of its 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 before being used in production.
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 supplier 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 will typically 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:

  1. All active raw materials pass through metal detection, magnets and fine mesh screens in order to trap any potential contaminants.
  2. All tablets pass through metal detection immediately after being pressed into tablets.
  3. The finished product passes through metal detection after packaging.

Our additional procedures ensure that no foreign material, including metal or physical contaminants have inadvertently entered the 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 reports EVERY serious adverse event that is reported to SafetyCall via the FDA MedWatch system.

LifeVantage has the most comprehensive quality assurance system in the industry. Because of our high quality standards, other companies are now requesting the same level of quality from their manufacturers and suppliers. We are proud of what we are doing to help raise industry standards and provide to you the safest, most effective products on the market.

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