Over the past few years, many manufacturers of herbal products have shifted from printing “expiration dates” on products to printing “manufacturing dates.” Across the industry, practitioners are noticing this change and wondering about its implications for product shelf life. Why the change in the industry standard and what does it mean for consumers?
Most practitioners assume that expiration dates are a required feature for product packaging that is intended to protect the consumer against dated product. However, in the eyes of the FDA, expiration dates are often used to benefit industry at the expense of the consumer. Many pharmaceutical companies have long used a practice of giving short expiration dates to products that have a long, stable shelf simply to encourage product turnover. Consequently, the FDA does not like to see products that are labeled with an expiration date unless there is scientific data to support that the product is good throughout its date and degrades beyond its date.
As of 2010, new cGMP requirements become mandatory for all dietary supplement manufacturers; thus many herbal medicine companies have also been researching labeling laws with renewed vigor. The FDA does not require herbal supplements to have expiration dates printed, and in fact the practice is discouraged unless the company has data to support that the product is not effective beyond its expiration date. Herbal products vary in the stability of their constituents; for example, Long Gu (Mastodi Ossis Fossilia) is unlikely to change over the next 10,000 years while Bo He (Menthae Herba) is quite volatile by comparison. It is likely that the shelf life of different products varies dynamically, but most of the products on the market have not been systematically tested for long-term stability.
How long do sealed, prepared herbal extracts stay fresh and effective? The question is difficult to definitively answer, but it is clear that sealed extracts last quite a long time. At least one large company has done stability testing to assess constituent levels on hundreds of sealed granule products, and their results showed minimal changes after even 7, 8, and 9 years. Based on the fact that hundreds of herbs have been tested way beyond the 3-5 year period of use that most companies specify, we can assume that the majority of extract products stay good well beyond their stated expiration date. However, the vast majority of individual products have never been subjected to long-term stability testing so we cannot be sure exactly how long they last.
In actual practice, often a factory will just ask the customer how long they want to date the product for, and that simple decision determines the expiration date. If we look at the same batch of granules from the same company, we may see a 4-year expiration date stated on the Asian market, a 3-year expiration date on the U.S. market, and a 5-year expiration date on the European market. The product is exactly the same but the expiration date is often arbitrarily based on the preferences of the target market.
Companies hesitate to put a long expiration date on their products because they fear that consumers will think the product is not fresh if its expiration dates extends 5-10 years into the future. At the same time, companies do not want to be responsible for products with 10-year expiration dates because they cannot be sure that each and every product would be able to scientifically show a lack of degradation a decade later. Multiple batches of constituent testing for every product would be expensive enough to cause price increases for practitioners and patients, and even if all companies began doing it tomorrow, the results wouldn’t be clear enough to interpret until 2020.
To be on the safe side, most companies put relatively short expiration dates on products because they know they can guarantee the product for say, three years. However, putting short expiration dates on products is problematic for practitioners. Practitioners cannot sell herbs to consumers when they are past their stated expiration date, and many practitioners hesitate to stock a wide range of formulas if they fear that they will eventually have to throw out the formulas that are less commonly used.
Given the absence of scientifically valid data that would firmly establish the ideal shelf life of each product on the TCM market, the FDA pressure to use manufacturing dates instead of expiration dates is ultimately a good thing for the field. In the past, manufacturers often felt that they needed to put expiration dates on their labels because other companies used them and no one wanted to stand out as an exception. Now that most companies are phasing out the expiration date model, practitioners will have less stress about discarding stock based on a stated expiry date that, in many cases, is somewhat arbitrary. Nonetheless, practitioners will need to be educated about the implications of this change so that they have an appropriate understanding of the situation.
Written by: Eric Brand, PhD
Originally published on June 22nd, 2010
Reproduced with permission from the author