Supplement and Drug Expiration Dates - Myth Or Fact?
Here’s a scenario: You get stung by a bee. You know, a jerk with wings. You rush to your medicine cabinet for some Advil and Benadryl, and find one or both of them went expired back when Obama was president. That was a long time ago, or at least feels like it.
Are these outdated medicines going to work? Will an expired medicine hurt me? Or, is the medicine expiration date another in a long line of Big Pharma (and Supplement Mega-Corporation) tactics to get you to spend more money?
There are numerous articles out there that discuss this, but I feel they are missing a few important points. I wish to talk about expiration dating in supplements and medicines, adding a little extra to the conversation. By doing so, I hope you’ll make better decisions around expired medications and supplements.
What Is An Expiration Date?
Simply put, a drug or supplement expiration date is a point in which the manufacturer can’t guarantee you have the same thing you originally bought. It’s clear with real food. There is no question when milk, apples, or fish is past expiration. Processed stuff, not so much. Wait, is this the secret behind the McDonalds french fry that's still wedged in between your car seat that looks EXACTLY the same as it did when you bought it 2 YEARS AGO?
It’s less clear with medicines or supplements. For the most part, they do look the same. However, expiration dating is going beyond how something looks (though that is important), and is looking at the actual molecules of the compound.
An expiration date is the point where an active ingredient has degraded below the legal limit for minimum potency.
This is an interesting concept for most of us. When we think of medicine, we think of them as stable and consistent, when in reality they are always changing. Medicines and supplements are under constant attack by things like light, temperature, and humidity causing them to lose their potency. A 500mg dose of amoxicillin will slowly decay. One day it may have 498mg. Over time it will keep decaying, usually down a slow curve like so:
A company is required to take a sample from their batch and put it through special testing processes to determine when, exactly, the product degrades below those legal limits.
With drugs, there’s an acceptable range. For example, a drug can be considered potent if it has anywhere from 90% to 110% of the labelled amount.
With supplements, though, there’s a stricter rule, known as the 100% rule. Know why? Dietary supplements are required to have 100% of their potency through the set expiration date. It’s so literal.
Here’s the REAL kicker with dietary supplements… The FDA does not require supplements to have expiration dates at all.
It’s not to say that vitamins don’t expire. Quite the opposite. But, a supplement has to only put the date it was manufactured. Many brands choose to do expiration date testing, as consumers demand it.
The Food and Drug Administration says it’s not required, but if supplement manufacturers use an expiration date, they have to provide sufficient data to prove that expiration date is real. They won’t tell you what constitutes sufficient data, though, as they said expiration dating is not required. The rules are weird.
Stability tests cost money. You better believe there are companies that decide that a 1 or 2 year expiration date is good enough because a 3 or more year test is cost prohibitive.
Are Expiration Dates Real?
I mean, they’re not the tooth fairy. It seems, though, that they are arbitrary based on “legal thresholds” and the cost-benefit analysis a company does on the testing around expiration dating.
Many people have said to me, “So what if it’s not 100% effective, I’ll just take more.” In theory this is right, but I’m not aware of any contact lenses or Google Glass that allows you to look at a pill and know exactly the potency of that one dose.
Expiration dates ARE real, but what I think many people mean when they ask this is, do products really expire? If they’re just weaker, why can’t I still use them?
A bigger point: many people have heard that drugs really don’t degrade that quickly at all! That’s probably because there’s a lot of media around some interesting studies done by manufacturers and government agencies about expiration dates.
For example, the FDA tested over 100 OTC and prescription products and found about 90% of them were safe and effective as long as 15 years past expiration.
Anecdote time: I worked for the VA before I opened the store. We knew that there were a few pallets full of pain meds and antibiotics in the event of an anthrax outbreak. These pallets had been there for decades. When tested, they had upper 90% potency.
The likelihood of your medicine or Vitamin C lasting as long as your new puppy is influenced by many factors. Let’s dig in to the things that determine a medicine or supplement’s expiration date.
What Effects A Medicine Or Supplement’s Expiration Date?
There are things that affect how fast a product slides down the decay curve, or how steep or dramatic this curve is:
- The active ingredient itself. Some are very easily destroyed or degrade very quickly.
- The formula. Inactive ingredients could impact the stability of the active ingredients, so it’s important that products are formulated with this in mind!
- Light. Excess exposure to our energy-dense sunlight can destroy an active compound.
- Temperature. Like small children in the summer, chemicals break down in the heat.
- Humidity. The number one killer of a chemical is water. Water is constantly attacking and breaking apart chemicals in a process called hydrolysis.
- Dosage form. Water’s the big bad daddy in active ingredient smashing, so in general, most water-based products will degrade much faster than powder in a capsule. A future blog article will discuss why I’m not the biggest fan of liquid supplements (especially vitamins), but the big reason is stability.
- The packaging. The bottle, jar, or bag the product is in will allow some level of heat, light, and moisture in, so we have to use the best package to ensure stability.
There are similar themes to all of those things: light, moisture, temperature. We have to do everything we can to protect our medicines and supplements from them to ensure best potency.
A medicine or supplement exposed to high heat, humidity, or light will degrade to an unusable level well before its expiration date.
Do NOT store your medicine in a hot, humid environment. Your medicine cabinet in the bathroom is best for your aftershave, razors, perfume, etc - not medicines. Even the kitchen, like near the sink or stove, can get very hot and humid. Pick the least worst place and try your best for a stable environment.
In general, controlled room temperature is about 70 degrees and about 40% humidity or less.
So here’s my big point about the expiration date articles: almost all articles discussing expiration dating say that it’s probably fine. You won’t get hurt, and in many cases the products don’t degrade to unusable for a long time - decades in some situations. The thing they neglect to discuss is that most of the real data around these super-long, real life expiration dates are in situations where the products are stored under optimal conditions.
Almost none of us will store our medicines or supplements in optimal conditions. The idea that your products are protected enough to have decades-long potency is pretty inaccurate.
Back to my VA anecdote: we had temperature and humidity monitors on it 24/7.
The Role Of Good Packaging In Expiration Dates
The package a supplement or medicine is placed in is the last barrier between the active compounds and the environment.
Bottles are normally made of a specific type of plastic or glass, a specific thickness, and a specific color.
There’s a reason prescription bottles are that weird color (blue, green, red, or amber like most have seen) - it protects the pills from light damage.
We have a big problem with supplements that come in clear packaging. I know mason jars are having a moment right now (looking at you, hipsters!) but save them for your pickling hobby instead.
Whether it’s a bottle or clear bag, that product WILL degrade quicker due to the light. Typically, a brand that is using transparent bags probably have a quality department that are either mostly sedated and napping at work or didn’t take basic pharmaceutics classes.
I had a patient once come to a pharmacy we owned holding a clear glass bottle with a loose fitting top containing a bunch of medicine in it, with no pharmacy label. She insisted we mixed up her pills, despite it being in a container more appropriate for catching lightning bugs. The transparent glass, the glass itself, and the lid all show the package was done incorrectly and it was a BIG concern for the stability of her meds. The big take home for her (and you): leave your medicines and supplements in the original containers to protect them and keep them as potent as you can.
The seal of the bottle matters. Not only are the bottle materials important, but the tops too. Inside bottles, often there are dessicants - little packages that you are not allowed to eat that absorb moisture in the air to prevent the pills from going bad.
Another pharmacy story: we had someone who called us two days after getting her medicine complaining she didn’t feel well. She said there was a packet that said “do not eat” and hasn’t had a meal since she started taking the drugs. Ba-dum-tiss.
You CAN throw those away, especially if it will convince you to not take in any calories. Some recommend keeping them around to help further lower the risk of moisture. Up to you.
Here’s a little tidbit about pharmacy bottles. The pharmacy stock bottles - the stuff that comes from the manufacturer - are tested for the expiration date. The pharmacy prescription bottles or “vials”- the stuff we give you with the pills in it - are NOT tested for that same length of time. They are tested for a general protection, and as such, most states require expiration dates to be no longer than 1 year once the pills are moved into prescription vials. Our stock bottle may say your ibuprofen 800mg is good until 2023, but the prescription we fill for you should be discarded after 1 year, because those bottles aren’t guaranteed to protect it the same.
More Supplement Expiration Caveats
Who wants more unique information about expiration dates and supplements? Don’t all answer at once!
The 100% Rule is pretty strict for supplements, but what we overlook is the super literal translation of this 100% Rule.
You have to have 100% of what you claim or what you are selling. If you are selling an acerola cherry powder, you must have 100% acerola cherry through expiration. The Vitamin C that’s naturally occuring, can degrade like crazy. As long as a supplement has 80% of naturally occurring actives in a food based product, it’s still considered potent. What’s a way to skirt the 100% rule? Claim your product is a food or is food-based.
When you buy bulk herbs, they’ll often be in transparent bags, normally with a poor seal, if any seal is present. Think of those bulk herb bins at health food stores. The 3 amigos show up to cause havoc on those herbs - temperature, light, moisture. But, it technically doesn’t expire, because the manufacturer is only claiming the whole herb itself, not the active constituents that actually do anything. You know, the reason you are buying it.
It’s these technicalities that supplement companies strategically exploit to get you to buy things that aren’t what you believe they are that bothers me most.
Can An Expired Product Hurt You?
If we think about what an expiration date is telling us, we see it is mostly about potency, or how much of the original dose are we actually getting. What we are asking, though, is it possible for the decayed/deactivated/expired part of the product to harm us in any way?
The usual answer is no, an expired product will not hurt you. There’s a single case report of a tetracycline expired product causing kidney failure in a patient, so people are pretty gun-shy with that product still, though many researchers don’t think much about the report.
In general, the only thing that happens as a product decays is it becomes less active over time.
A Forgotten Feature - The Gross Factor
Becoming less active or completely inactive is the part we all focus on, but I think it’s the least important part.
“So why can’t I use my super-outdated supplement or medicine?” Because it’s gross!
Bacteria, mold, and fungus can grow on organic materials. Think about the yummy gelatin capsules, the softgels, the inert ingredients that may feed microbes, and all that fun stuff.
It gets grosser when you move from synthetic compounds typically found in vitamins and supplements and move to more “natural” options - real food powders, botanicals, and even oils. These things will spoil and get gross REAL quick.
Would you eat 3-year-old cereal? Do I need any more examples illustrating this point? Why are there so many rhetorical questions in this post?
Testing For Expiration Dating
We normally think of just the potency when we think of expiration dating, but there’s so much to consider. Here’s what we think of or look at to do thorough expiration dating:
- Chemical tests to determine potency
- Water content, weight changes
- Gross checks - is there a different color, odor, taste, or texture?
- Physical appearance - are the tablets, capsules, or liquids physically the same as when they were first made? Or are they harder, crumbly, etc?
- They’ll check for the ability to disintegrate or dissolve. Powders are checked to ensure they don’t cake up.
- They check for bugs. Microbes like mold, fungus, etc.
And there’s more. The big take home, if it hasn’t become apparent: expiration dating is different than the media lets you in on. Much more!
Don’t Use Medicine Or Supplements Past Expiration Date
I’m in the camp that there is no good reason to use a medicine or supplement past expiration date, even if they could be potent. If you needed something for pain or allergies urgently, sure, but the next step is to get to a store to get a fresh supply.
No one listens to me, though. Especially not my kids. If you are going to use expired medicine, definitely NEVER EVER EVER use these types of medicines past expiration:
- Antibiotics, especially liquid antibiotics - do you want to use a subpotent antibiotic, improperly treating an infection, and perhaps leading to antibiotic resistance? You shouldn’t be self prescribing antibiotics anyway!
- Insulin, and in general, any hormone - Hormones are pretty unstable when exposed to heat, light, and moisture. They’re too vital to mess around with.
- Nitroglycerin, blood thinners, arrhythmia medicine - I mean, come on…
I would hope that everyone understands the big difference between mission critical medicines (inhalers, diabetes meds, heart drugs) and “comfort” meds (pain, swelling, etc).
Expiration Dates: It’s Fine, But It’s Not
The articles and advice online about expiration dating gives consumers the feeling of “Most expired drugs/supplements are fine.” That’s not an accurate statement. What they SHOULD say, is “most drugs/supplements are still potent after expiration when stored appropriately.”
An expiration date is the point in which a medicine or supplement no longer has the guaranteed amount of active compounds, determined by the regulations. An expired medicine still may have potency that’s acceptable despite being past expiration. Almost no products will degrade into something that will harm you.
There’s still much to consider when we take old medicines or supplements. The grossness is the biggest thing; we must consider microbial growth like mold and fungus.
The biggest consideration is mini-rant worthy: why? If it’s the scenario we highlighted in the opening here - you’re in an emergency situation and you need something right now, but all you have is an expired option, then it is probably ok. I’m most worried about your products being outdated because you’re not using them consistently.
The best medicine is prevention. Frequently clean out your medicine cabinet. Maybe the Wellness Pyramid needs a contingency for cleaning your medicine cabinet out regularly and keeping a list of must-haves in good dating, in the proper packaging, stored correctly. I’m on it!
So, yes, theoretically you can use a product after expiration date with little problem in most situations. But don’t, because it’s gross. Remember the french fry.
Just trying to keep it real...
Neal Smoller, PharmD
Owner, Pharmacist, Big Mouth