Expiration dates vs. Manufacture dates affects price and freshness

This coming June, all manufactures of dietary supplements must have in place the FDA’s updated compliancy regulations called cGMP’s. What does this mean to you, the consumer? Within these lengthy new regulations come several confusing surprises. One of these new surprises is the use of Manufacture date verses Expiration date. You will see either an Expiration Date or Manufacture Date on your supplements. Since the FDA published their Final Rule on 21CFR Part 111 in 2007 for current good manufacturing practices (cGMP’s) they have given manufactures the option of using either an Expiration Date or a Manufacture Date on their finished products.

The FDA declined to add a requirement for expiration /shelf-life dating, although the agency encourages its use. It seems the FDA believes there are not generally available methods for all ingredients sufficient to determine expiration dating, especially for botanical dietary ingredients. Manufacturers that do use an expiration date must now have scientific data/studies to support the selection of this date. If they do not have the supporting data the FDA could, at their discretion, impose fines, sanctions, recalls or closures on the company who manufactures the product.

Expiration and manufacture dates: What’s one to think?

The FDA guidelines do not include methodology or suggested procedures for the supporting data/studies; instead, they suggest “This is an evolving model.” What this means is that additional extensive stability studies must be undertaken that can last sometimes well over 6 months and will eventually increase costs sharply that will be passed on to the consumer. Most manufacturers are already burdened with the task of keeping the costs of products down on a regular basis.

• But as far as FDA Regulations are concerned, any company who chooses to use expiration dates on their products must conduct these additional stability studies and provide the scientific data /studies to them before the product can be released to the market place.

With respect to Stability Testing of Dietary supplements & Nutraceutical Formulations, –From the FDA’s preamble text:

• No requirements for dissolution, disintegration, bioavailability, or expiration dating occur because “scientific studies are still evolving…”
• The agency considered whether to propose requirements in this proposed rule for expiration dating, shelf life dating, or best if used by dating, but is uncertain whether there are current and generally available methods to determine the expiration dating especially botanical dietary ingredients. We are not proposing expiration dating at this time because we have insufficient scientific information to determine the biological activity of certain dietary ingredients. . . Further, because official validated testing methods (i.e., AOAC or FDA) for dietary supplements are evolving, especially for botanical dietary ingredients, few official methods are available to asses the strength of a dietary ingredient in a dietary supplement

While all this information could be confusing for some, there is a light at the end of the tunnel with respect to Manufacture Date verses Expiration Date. Here are some Pros & Cons of this Proposed Rule:

CON:

When a product is bottled & labeled for distribution if the manufacture chooses to use the “Expiration Date,” additional holding time for stability studies must be added on before it can be sold at the consumer level. The finished product is then about 6-12 months old before it is even released for sale to you the consumer reducing freshness and overall efficacy, the very thing you want in your health products has now been decreased.

PRO:

The consumer may not be aware that most ‘Raw’ product manufacturers perform stability studies. They must hold & test their products usually somewhere between 1 and 6 months before they ship the “raw” unfinished goods to the manufacture.

While the FDA is caught in a quagmire of undetermined testing and validity, freshness and reliability is available via Manufacture dating. With Manufacture dating the finished product is ready to be sold at the consumer level without the extra-added 6-month wait. As a result, the product you purchase will not be decreased in freshness or efficacy.

We at AMERIDEN® have chosen to use the “Manufacture Date” on our finished products instead of the Expiration Date, as of February 2010, so you will receive the freshest product available when you order and will not incur an increased product cost that Expiration Dating would cause.

AMERIDEN® guarantees their products to be good for 3 years past the Manufacture Date.