Best Before and Expiry Dates for Food and Drugs

Best Before and Expiry Dates for Food and Drugs2016-11-30T11:43:59+00:00

Most of us with gastrointestinal maladies such as IBD (Crohn’s disease or ulcerative colitis), reflux disease (GERD), IBS (Irritable Bowel Syndrome), or one of the myriad others, know from first-hand experience the price paid for ignoring warnings about taboo foods or inappropriate drug regimes. We may pay the price in pain, with increased lethargy, inadequate nutrient absorption, diarrhea, fever, disorientation, and fatigue. These are the penalties for indulgence in the forbidden.

But what about those foods and medicines that are okay; the ones you need and that your body can handle? What can you be doing to ensure that these foods remain nutritious and safe, and that the drugs remain effective? Read the labels. Pay particular attention to the “best before” or “expiry” dates. These indicators of shelf life can help to safeguard your health and provide some assurance that okay will really be okay.

 

What do the dates on the labels mean?

Food – “Best before” Date

The durable life dating

[“best before” date] of food products is defined by the Canadian Food and Drugs Act and Regulations.1 Durable life is the period, starting on the day a food is packaged for retail sale, that the food will retain its normal wholesomeness, palatability, and nutritional value, when stored under conditions appropriate for that product. Dating information and instructions for proper storage are required on most foods, which have a shelf life of 90 days or less.

It is up to the manufacturers and retailers to determine the durable life of foods they manufacture and sell. The dating information they provide indicates quality not food safety.2 Any pre-packaged food product having a durable life of 90 days or less must have a durable life date on the label, expressed as the “best before” date, and instructions for proper storage. Look on the label for the statement “best before” coupled with the month and date, for example, best before OC 15. It may not say “best before” if there is an explanation of the significance of the durable life date somewhere else on the label. Expiry date is not a term used with food in Canada. The only exception is infant formula, which does carry an expiration date.

Products packaged at the retail store with a durable life of 90 days or less may be labeled with either a durable life date and any necessary storage instructions, or a packaging date and accompanying durable life information, on the label or on a poster next to the food. Fresh fruits and vegetables are exempt from this labeling but meat must follow the regulations.

The federal government’s Canadian Food Inspection Agency (CFIA) enforces the federal labeling requirements for pre-packaged foods under the Food and Drugs Act and the Consumer Packaging and Labeling Act. Among the basic labeling requirements for pre-packaged foods are the common name, net quantity, ingredients, “best before date”, and responsible party by or for whom the packaged food is manufactured or produced. Inspectors review food labels for accuracy, investigate complaints, and charge offenders.3

The Canadian Food Information Council (CFIC), a national, non-profit organization that works with the food, nutrition, health, and scientific communities, and with media to provide information on current food, food safety and nutrition issues, in an article written for the Health Canada information website, states that “durable life dating” is critical to safe food handling by the consumer. A glance at many meat counters today and you will find “best before dates” in use more frequently than “packaged-on dates”.4 Both are based on durable life standards established by Health Canada.

Should I throw out food past the “best before” date? The durable life date is valid only for unopened products. Once opened, the product should be consumed at once. Foods susceptible to spoilage should not be consumed if the “best before” date is passed. Even if a food shows no signs of spoilage, it can harbour pathogenic microorganisms that can cause foodborne illness. Foods that are not susceptible to spoilage can usually be consumed past their “best before” date. These foods may have lost some of their original flavour and nutritional value. Use your senses (sight, smell) and common sense to decide if it is appropriate to eat it.2

When in doubt, throw it out.

 

Drugs – “Expiry” Date

For drugs and natural health products, an “expiry date” indicates the shelf life and the stability of the product. Read the label to make sure the expiry date hasn’t passed. Like foods, drugs and supplements should not be used after their expiry dates. Look for the DIN (Drug Identification Number) or GP (General Product) number, usually on the front label, which shows that the product was approved by Health Canada.

The Act and its regulations apply equally to the distribution by manufacturers of drug samples to medical professionals for use with patients. Samples may be distributed only when labelled in accordance with the Regulations. There has been an incorrect perception that the labelling requirements for a sample are less stringent than those required for other package sizes of prescription or non-prescription drugs. The lack of a clear guideline has created inconsistency in labelling. Health Canada has recently issued new guidelines to clarify these requirements.

Health Canada’s Therapeutic Products Directorate is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to receiving market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy, and quality as required by the Food and Drugs Act and Regulations.5

 

Should I throw out drugs past the “expiry” date?

For the vast majority of drugs, the legislation only stipulates the testing procedures that must go into determining shelf life, leaving it up to the manufacturer to submit what they believe to be a reasonable variance in the potency and efficacy of each product. The approved shelf life of a specific drug, therefore, may be based on any of a wide variety of criteria, including stability of active ingredients over time or maintenance of potency beyond the expiry date by a high percentage of the product. An example found in research by the Alberta College of Paramedics stated, “95 per cent of batches tested maintained at least 90 per cent of listed potency (beyond the recommended shelf-life)”.6

The one common thread that was found throughout the various Health Canada guidelines and good manufacturing practices documents was that a drug’s shelf life is based primarily on its effectiveness. This conclusion was further supported by consultation with practicing physicians and pharmacists carried out by the Alberta College of Paramedics. A spokesman for the Alberta College of Pharmacists stated that although he wasn’t aware of any specific regulation enforcing it, a general rule of thumb is that a drug, on expiration, will maintain about 90 per cent of its initial effectiveness. His opinion was that a drug’s expiry date should be interpreted as the latest date on which the manufacturer will warrant its effectiveness.6

Some readers may be getting the impression that drug expiry dates are not very important if the worst that can happen is they become a little less effective, however, failure to observe the shelf life of a drug or IV solution is not without its risks. Aside from any possible danger to the patient resulting from the administration of a product that may not have the expected effect, there could be an increased risk of liability for the practitioner who uses an outdated product, regardless of whether or not it actually contributed to the adverse patient outcome. The College of Paramedics points out that even though the use of a drug or IV past its expiry date may cause no harm to a patient, the fact it was used may suggest that the practitioner is less than diligent. A legal advisor whom they consulted for comment on the issue said, “While that argument is not tenable in and of itself, it may find favour with some on the bench and isn’t worth the risk or aggravation.”6

There is considerable debate around the issue in the US as well. The US Food and Drug Administration, on behalf of the Department of Defense, tested 100 prescription and over-the-counter drugs. The results indicated that 90% of them were safe and effective far past their original expiration date, at least one for 15 years past it. In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Mr. Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn’t mean, or even suggest, that the drug will neither stop being effective after that, nor that it will become harmful. “Manufacturers put expiration dates on for marketing, rather than scientific, reasons,” says Mr. Flaherty. “It’s not profitable for them to have products on a shelf for 10 years. They want turnover.”7

Richard Altschuler, a health consultant for American universities conducted research on the issue for an article on expiration dates for medications. He states that although an expiration date has been required by law in the US since 1979, the expiry date specifies only the date the manufacturer guarantees the full potency and safety of the drug – it does not mean how long the drug is actually good or safe to use.8

Altschuler quotes Joel Davis, a former FDA expiration-date compliance chief, who said that with a handful of exceptions – notably nitroglycerine, insulin, and some liquid antibiotics – most drugs are probably as durable as those the agency has tested for the military. “Most drugs degrade very slowly,” he said. “In all likelihood, you can take a product you have at home and keep it for many years, especially if it’s in the refrigerator.”8

Consider aspirin. Bayer AG puts two-year or three-year dates on aspirin and says that it should be discarded after that. However, Chris Allen, a vice president at the Bayer unit that makes aspirin, said that the dating is “pretty conservative”. When Bayer has tested four-year-old aspirin, it remained 100% effective. So why doesn’t Bayer set a four-year expiration date? Because the company often changes packaging, and it undertakes continuous improvement programs. Each change triggers a need for more expiration-date testing, and testing each time for a four-year life would be impractical. Bayer has never tested aspirin beyond four years.8

Drug manufacturers acknowledge that expiration dates have a commercial dimension, but they say relatively short shelf lives make sense from a public-safety standpoint. New, more-beneficial drugs can be brought on the market more easily if the old ones are discarded within a couple of years. Label redesigns work better when consumers don’t have earlier versions on hand to create confusion. From the companies’ perspective, limiting the period during which a consumer might misuse or improperly store a drug diminishes any liability or safety risk.

However, there is much speculation on how many drugs are discarded and destroyed that are still perfectly good. For drug plans, for example, does the discarding of still-potent and safe drugs increase the reimbursement of medication costs? The World Health Organization has concerns about third world countries spurning donations from drug companies of much needed medications that are too close to their expiry dates. This potentially wastes effective solutions to overwhelming drug shortages unnecessarily.

“People think that, upon expiration, drugs suddenly turn toxic or lose all their potency,” says Philip Alper, professor of medicine at University of California, San Francisco. In his own practice, Dr. Alper says, “I frequently hear – from patients who can’t afford medicine – that they have thrown away expired drugs.” He says companies should be required to test drugs for longer periods and set later expiration dates when results warrant.9

It isn’t known how much of the $120 billion-plus spent annually in the US on prescription and over-the-counter medicines go to replace expired ones. However, in a poll done for The Wall Street Journal by NPD Group Inc., 70% of 1,000 respondents said they probably wouldn’t take a prescription drug after its expiration date; 72% said the same of an over-the-counter remedy.10 Dr. Gabriel M. Maliha, Dean of the School of Pharmacy, Lebanese American University, concluded her article on the subject, “It should be noted that health professionals’ primary responsibility is to serve the public and to provide their patients with the best possible care. Data from drug manufacturers as well as from the US military are both economically motivated. The manufacturers are looking for a fast turnover, the US military trying not to discard its expired stocks. No pharmacy, or a “home drug-cabinet”, would at anytime, contain a costly stock of expired medications. Therefore, it would probably be safer for patients to dispose of any expired medications.”11

While it is simple to find the expiry date on the package of over-the-counter medications, when you have a prescription filled at a pharmacy, often your medication is no longer in the manufacturer’s container. To be certain about your medication, it is a good idea to ask the pharmacist to write the product expiry date on the bottle at the time your prescription is filled. Finding out later may be too difficult.

 

Don’t Chance It!

Do you really want to take the chance? What if the foods eaten past their durable life dates are contaminated? What if the drugs have lost some (or all) of their potency? Even though very rare, what if they do become toxic?

We all know that we need to be careful about the way we treat our bodies, the way we cope with our conditions, and the way we ensure that we stay as healthy and fit as possible. Reading the labels can help us do this. Ignoring their warning is foolhardy.


Claudia Roberts, MBA, CGA
First published in the Inside Tract® newsletter issue 139 – September/October 2003
1. Health Canada [2002], Food and Drugs Act and Regulations,
2. University of Guelph Website – Food Safety Network, www.foodsafetynetwork.ca
3. Canadian Food Inspection Agency (CFIA), [2000], Guide to Food Labelling and Advertising, www.inspection.gc.ca/english
4. Canadian Food Information Council, Reducing Risks – from farm to table, www.inspection.gc.ca/english
5. Health Canada, Therapeutic Products Directorate, www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt
6. Alberta College of Paramedics, Newsletter, Spring 2001, www.collegeofparamedics.org
7. Wall Street Journal [March 29, 2000], reported by Laurie P. Cohen
8. Richard Altschuler, Do Medications Really Expire – Try an Experiment with Your Mother-in-Law, Redflagsweekly Newsletter, September, 2002, www.Redflagsweekly.com
9. Ibid
10. Wall Street Journal [March 29, 2000], reported by Laurie P. Cohen
11. Dr. Gabriel M. Maliha, M.D., Ph.D., Dean – School of Pharmacy – Lebanese American University, How Safe & Effective are Drugs beyond their Expiry Date? School of Pharmacy Newsletter, www.atebba.org/mag8/expiry.htm