PRODUCT NEWS

Why We Use a Manufacture Date Instead of an Expiration Date

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We have switched to a “Manufacture Date” (MFG) instead of an “Expiration Date” or “Best By” date on our dietary supplements and skincare products.

Because an Expiration Date omits so much information and creates the possibility of a false illusion of product quality, we’ve chosen to use the more precise and unambiguous “Manufacture Date” on product labels.

The dietary supplement industry is regulated by the Food and Drug Administration (FDA). As a part of that regulation, all segments of the dietary supplement industry are regulated under the final rules found for the Current Good Manufacturing Practice (cGMP) in the Code of Federal Regulations, 21 CFR Part 111, regulating Dietary Supplements. The Dietary Supplement cGMP final rule found in 21 CFR Part 111 does not require expiration dating for dietary supplements (see 72 Fed. Reg. 34752 at 34855 June 25, 2007). Homeopathic remedies are also exempt from expiration dating (see 21 CFR Section 211.137).

Not only does the FDA eschew requiring an Expiration Date and specific methods for determining one, but also notes that there are currently no reliable methods to measure the shelf life of many of the ingredients found in dietary supplements.

An Expiration Date provides no assurance of quality, activity, potency, bioavailability, effectiveness or any other parameter the consumer might use to evaluate the dietary supplement. Therefore, an Expiration Date, in itself, is relatively meaningless without knowing how it was derived. When asked, the company should provide the following information:

1. The specific ingredient(s) tested to determine an Expiration Date for the product
2. The laboratory processes and instruments used to test shelf life (e.g. accelerated aging) and details about those processes, such as temperature, duration and pressure used
3. The acceptable outcome(s) for that particular ingredient(s) and test(s) according to industry standards

Our steadfast commitment to quality goes way beyond using an accurate date. All of our products are expertly formulated, pure, potent and science-backed. We only work with select manufacturers of impeccable integrity who meet and even exceed our high standards as well as being cGMP certified.

Before an ingredient is allowed in our formulas, the supplier must provide a certificate of analysis (COA) certifying the potency and purity of that product. In addition, each ingredient must pass a microbiological and heavy metals test. Only if the pretests are acceptable, is it allowed as an ingredient. After each product is manufactured, it is tested by the manufacturer before being shipped to us. Once we receive a product, it goes immediately into a quarantine area where it is held until it is again tested by a third-party, independent Clinical Laboratory Improvement Amendments (CLIA) certified lab using the appropriate tests for that product. In addition, the finished product undergoes a final third- party independent testing for microbiological and heavy metal safety.

We design our products to have maximum clinical effectiveness, which is why many of our customers are medical doctors and pharmacists. They have found from their own experiences that they can rely on our commitment to producing the best quality products possible for their patients and clients. This translates into clinical effectiveness in their clinics and pharmacies. Because they understand that an Expiration Date on the bottle of a dietary supplement has little meaning without detailed information about the process each company uses to determine expiration dates, they typically prefer the more specific and accurate Manufacture Date.

In summary, there is much more that goes into product quality than the expiration or manufacture date. When you buy a product, you’re really buying a company. You are buying its philosophy, mission, commitment, integrity, orientation to business, quality control, product quality, leadership, formulating skill, and a number of other factors to make a product what it is.