Regulatory Practices

nutraMetrix is committed to providing products of the highest quality.

Creating a superior supplement begins with quality ingredients. The raw materials used in nutraMetrix® products undergo a comprehensive evaluation by our manufacturers to ensure that they meet stringent purity and potency requirements. Verification and approval by a certificate of Analysis (CoA) is required for each raw material. Approved raw materials are subject to laboratory confirmation of physical characteristics and material potency, as well as an analysis for microbiological contamination and heavy metals. Each nutraMetrix® product is then carefully prepared following a written master manufacturing record and every batch is reviewed and approved by our manufacturer’s highly-trained quality control personnel. Products are also inspected at our warehouse for damage, label accuracy, appearance taste and identity prior to use.

Mark Lange

An Interview with Dr. Mark Lange Senior Director of Product Quality and Information for nutraMetrix and Market America, regarding Regulatory Practices.

1. What is the overall goal of the nutraMetrix Quality Control Department?

Quality Control (QC) is following procedures intended to ensure that manufactured product adheres to defined quality criteria or meets the requirements of the customer. In order to implement an effective QC program, manufacturing standards are set, and testing standards are established. But QC’s goals are much broader than simply testing product. If a product fails to meet specifications, corrective action is taken by the manufacturer to improve the production process before producing the next batch.

2. Market America/nutraMetrix ensures that certain regulatory standards are met before the products ever come to our facility. What sort of testing is completed prior to the products arriving at the corporate headquarters?

It depends on the nature of the product. Dietary supplements will undergo chemical testing to assure label claims are supported, in addition to micro and heavy metals content testing. Cosmetics and skincare products typically will be screened for microbiological contamination, pH, viscosity and color match. Dietary supplements will undergo chemical testing to assure label claims are supported, in addition to micro and heavy metals content testing. The testing records are kept on file for a minimum of one year past the product’s expiration date.

3. What are the regulatory standards that must be met by law?

All dietary supplements must conform to Federal regulations that control their manufacture, labeling, and advertising. In order to sell an herbal supplement, a manufacturer must meet many different Federal (and sometimes state and international) requirements. Since supplements are legally classified as a specifically defined type of food, supplements are required to be manufactured to the same high standards that are required of all foods. These mandated good manufacturing practices (GMPs) establish basic guidelines to assure that supplements are manufactured under sanitary conditions that result in properly identified products that are not contaminated or adulterated. Any supplement that does not conform to these basic guidelines is subject to regulatory action by FDA.

4. Since much of the testing is done in other facilities, does Quality Control ever visit these facilities?

Absolutely. In addition to reviewing documentation originating from the manufacturing facility, we need to be aware of what’s going on at contracted facilities. This is best done with eyes on the ground using knowledgeable people who will give firsthand information about their observations. Our Director of Quality Control, Lyn Hardway, is specifically trained and certified in quality systems. Her auditing typically takes two days and covers everything from sanitation to record keeping. We also have staff members who specialize in monitoring quality control in our international markets.

5. What sort of testing or sampling is done in-house?

Market America/nutraMetrix distributes manufactured products; therefore it makes sense that the actual testing of product be performed by the manufacturer before it leaves their facility. The manufacturer may use their in-house lab or an independent lab. But that’s just the beginning of the inspection process. When the shipment arrives at our warehouse, random samples are removed and brought up to the lab. Here, product is compared against previously manufactured lots for consistency and documentation from the manufacturer is matched up to confirm that proper testing was performed, and the product was packaged and labeled properly.

6. What other duties is Quality Control responsible for?

Quality Control plays an essential role in regulatory affairs, which is ensuring compliance with global regulations and laws. This means keeping abreast of international legislation and guidelines in all countries we export to. The licensing and authorizing of dietary supplements and cosmetics in foreign markets is complex. Quality Control is called upon regularly to develop and write clear arguments and explanations for new product licenses and license renewals. As you can imagine, there’s a great deal of paperwork that must be managed and we take pride in our filing and retrieval systems which can quickly locate needed documents.

7. How is testing for GMO performed?

Finished product is tested by an independent laboratory using PCR (polymerase chain reaction) for GMO detection. This sensitive test is able to detect GMO even in samples containing only minute quantities of DNA. Only a handful of techniques are currently used to genetically modify most plants. The laboratory is looking for the traces of genetic modification that is left behind by these techniques.

8. What other departments within Market America/nutraMetrix does Quality Control interact with, and how?

Quality Control interacts with many departments throughout a product’s life cycle. In the beginning, QC works with the Science Department in collecting and evaluating scientific data supporting the licensing and registration of a new product. The manufacturer’s GMP compliance responsibilities are outlined by QC for the Legal department to incorporate into contracts and agreements. The Warehouse holds received shipments until QC inspects and gives approval for accepting the product into inventory for distribution. If a received product is defective, it is quarantined. This impacts Inventory Control and Purchasing Departments because replacement product must be brought in to prevent a backorder. To keep everything moving, QC personnel must be exceptionally organized and pay keen attention to detail. One oversight can have detrimental effects on product safety or can delay a product’s release.