Why We Use Manufacture On Date Instead of Expiration Date
The question has arisen several times as to why Doctor Wilson’s Original Formulations uses a “Manufactured On Date” on its dietary supplement bottles rather than an “Expiration Date”. This is a good question and deserves an answer.
First let’s look at the legal requirement. 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).
Any company that does use an Expiration Date (or “Shelf Date” or “Best Used By Date”) on their products must have data to support that date (see 72 Fed Reg 34752 at 34855). In a FDA warning letter to Biogenix USA LLC 12/11/14, the agency stated, “Any expiration date or equivalent term a company places on a product label should be supported by data that demonstrates the product’s shelf life.” – citing 72 Fed Reg 34752, 34855 (Jun 25, 2007).
In Fed Reg document 34855, the FDA stated, “We recognize that there are current and generally available methods to determine the expiration date of some dietary ingredients, such as Vitamin C. However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients. We did not propose to require expiration dating because we had insufficient scientific information to determine the biological activity of certain dietary ingredients used in dietary supplements, and such information would be necessary to determine an expiration date. Further, because official validated testing methods (e.g. Association of Official Analytical Chemists [AOAC International]), for dietary supplements are evolving, especially for botanical dietary ingredients, such methods are not always available to assess the strength of a dietary ingredient in a dietary supplement.” The FDA concludes by stating, “Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a best if used by date) should be supported by data.” In other words, there is no requirement to place a date of expiration on a product. A dietary supplement company may use either the date of expiration or of manufacture. Either is acceptable for cGMP compliance.
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. This leaves a large gaping hole in the ability of any dietary supplement company to determine a valid Expiration Date for its products.
There are several approaches dietary supplement companies have taken to creating an Expiration Date. They may have selected a single ingredient in a multiple ingredient formula to test for shelf life, or tested multiple ingredients and averaged their shelf life or chose one to be representative. However, this may be quite misleading. For example, a mineral has an almost infinite shelf life, much longer than that of most vitamins, but the consumer does not know which ingredient(s) determined the Expiration Date for the product.
There is no requirement by the FDA for frequency of shelf life testing or how many lot numbers can expire between tests, or for ascertaining any other data that would normally be considered useful in determining shelf life. There is not even an FDA requirement that the tested ingredient(s) retain full potency for the entire shelf life. It is therefore more or less up to the company whose name is on the label to determine what it believes to be an adequate representation of shelf life. The only caveat is that the company is supposed to make the information it used to determine the Expiration Date available if someone inquiries. In our experience, that information is rarely forthcoming upon public request.
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:
- The specific ingredient(s) tested to determine an Expiration Date for the product
- 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
- The acceptable outcome(s) for that particular ingredient(s) and test(s) according to industry standards
Because an Expiration Date omits so much information and creates the possibility of a false illusion of product quality, Doctor Wilson’s Original Formulations has chosen to use the more precise and unambiguous “Manufactured On Date” on product labels. But our commitment to quality goes way beyond using an accurate date. Each of our products is formulated by Dr. James L. Wilson, an internationally known leader in the alternative and natural health industry who has decades of clinical experience, a background in science and proven expertise in formulating. Because there are many ways to cut corners in manufacturing dietary supplements, even among cGMP certified manufacturers, we only work with select manufacturers of impeccable integrity who meet our high standards as well as being cGMP certified. We believe the health of our customers is too valuable to sacrifice quality on any ingredient. So one of the ways we eliminate inferior ingredients is to work only with known quality raw ingredient suppliers to provide the best ingredients in our products. 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. If it does not meet our specifications, that product is returned to the manufacturer.
Only after each product meets all of our quality control specifications is it released from quarantine and ready for distribution. Once a product enters our warehouse, it is kept in a climate controlled environment at 68-70°F with a relative humidity of 10-15% to preserve product freshness. We carefully control our supply chain and our product turnover is high so products do not stay on the shelves for extended periods. In addition, all of our staff are trained in cGMP procedures and our company is certified to be cGMP compliant by a third-party, independent company who is a member of the American Society for Quality (ASQ) and whose inspectors are Certified Quality Auditors (CQA).
We design our products to have maximum clinical effectiveness, which is why over 80% of our professional 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 Manufactured On 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. At ICA Health and Future Formulations, our commitment is to produce the highest quality, most clinically effective products possible. They are formulated by a doctor from the perspective of what will provide the greatest benefit to the person taking them. Each team member is dedicated to the same high values, as well.
As a way of saying we believe in our products and the quality built into them, we offer a no questions asked, 90 day money-back guarantee on all our products – a rarity in the dietary products industry.