Why Are There Ingredients Overages in Vitamins and Supplements?
Many of the brand owners that contact us about supplement manufacturing services ask us lots of questions about overages. They specifically want to know what they are, why they are important, and how underages can hurt their business. For these reasons, I decided to write the following blog article. I encourage you to read it or listen to the podcast I recorded about this topic.
When considering issues of product quality, testing, and manufacturing, you don’t often hear anything about ingredient overages in vitamins and supplements — and yet they are vitally important to help ensure product potency and efficacy as well as expiration dating. This article will provide an overview of overages, defining what they are, why some manufacturers purposely provide underages, the price your brand can pay if it fails to meet label specs, and most importantly, what you can do to protect yourself.
What Are Overages in Dietary Supplements?
An overage is the amount of a nutraceutical that is included beyond the amount claimed on your label when your supplement is being manufactured.
How Do You Calculate Vitamin Overages?
For example, let’s say the Supplement Facts Box on your product lists vitamin C at a level of 100 mg and it has been determined that the overage should be 10%. Since 10% of 100 mg is 10 mg, that would be your overage, and the total amount of vitamin C included in your product would be 110 mg — although the Supplement Facts Box would still state 100 mg.
Now, if you’re wondering why it's important to include an overage in the first place, the answer is that overages help to compensate for any decline in the level of that nutraceutical that may occur during the lifespan of the product — and nutrient levels do decline with age. So as a dietary supplement sits in the warehouse or on retail shelves, the nutrient levels will lessen over time. That means that if you have an expiration date of two years after the manufacture date, you will need an overage of the nutraceuticals provided for the product to maintain its full potency during those two years.
How Are Vitamin and Supplement Overages Determined?
Dietary supplement contract manufacturers (CMs) routinely conduct stability testing to see if a product is able to maintain its potency through the expiration date. If it doesn’t, then the CM will increase the overage for those declining nutraceuticals until they maintain their full potency. After many years of stability testing hundreds of dietary supplements, CMs have been able to ascertain the best overage levels for different nutraceuticals — and some need a higher percentage overage while others are fine with a smaller percentage overage.
Recommended Overages for Vitamins
For example, a 3% overage may be fine for calcium, but a 10% overage is a better choice for vitamin C. Of course, if you have a probiotic, you may need an overage that is 100% or more. An experienced supplement contract manufacturer like NutraScience Labs can help determine appropriate percentage overages for each nutraceutical. In fact, we’ve helped over 2,300 dietary supplement brands around the globe manufacture and bring customized, high-quality nutraceuticals to the market, so we know a thing or two about this topic.
Do All Contract Manufacturers Use Overages? What About “Underages"?
In case you’re wondering if all contract manufacturers include overages when producing dietary supplements, the answer is that they should be doing it — otherwise the product will not maintain its potency and there are ramifications for that (more about that below.
So, why would a contract manufacturer choose NOT to use overages? Even worse, why would they even go so far as to use "underages" — meaning that they purposely put in less of a nutraceutical than it states on the label?
The unfortunate answer is that it allows them to be more price competitive. If they’re putting in 5% less of this, and 10% less of that, in the end, they’ll be able to come back with a lower price for the finished product. This may save a few bucks on the front end, but when your product doesn’t meet its specification, it quickly becomes evident that it was a penny-wise and dollar foolish decision.
What Are the Ramifications of a Supplement Not Meeting its Label Specification?
There are actually a few different ramifications. First, let’s assume you have a well-formulated product that is supposed to provide a clinically relevant dose of one or more nutraceuticals. If so, then failure to meet the spec means that your product lacks the full potency to provide the benefit it is supposed to provide to the consumer. Sooner or later (often sooner), consumers will notice that the product isn’t working as expected, and will stop using it. This is not good for your business.
Secondly, a third-party organization may have your product tested for its potency, and when it comes up short, you’ll have egg on your face—especially when the results of the testing are publicized. This is happening more and more frequently.
A third very real possibility is that you may find yourself in the midst of a routine FDA inspection. If, during that inspection, the agency determines that your product doesn't meet product specifications, you may receive a Form 483, indicating that your product is in violation of the Food Drug and Cosmetic (FD&C) Act and related Acts. Since Form 483 is listed on the FDA's website, this means that anyone, including your customers and competition, will have access to your dirty laundry, which can do significant harm to your brand's reputation.
How Can You Avoid These Problems and Protect Your Dietary Supplement Brand?
The good news is that you can protect yourself against these problems. Your best strategy for avoidance is to have your products manufactured at a reputable CM that routinely includes overages in the supplements. If you wish, you can also request third-party testing to verify that your products provide the correct amount of each nutraceutical. If you’re concerned about budgetary considerations, you can even contain costs by rotating nutraceuticals testing rather than testing all of them at once. For example, if there are four nutraceuticals in the formula, you can have one tested with the current lot, then have another nutraceutical tested with each of the three subsequent lots.
Wrapping Up the Discussion of Ingredient Overages in Vitamins and Supplements
To summarize the key points:
- Overages are important because they help ensure product potency and efficacy as well as expiration dating;
- Ramifications of your product failing to meet label specifications can include that consumers stop using them and the FDA may identify your sub potent product on their website for all to see;
- You can protect yourself by working with a reputable supplement contract manufacturer like NutraScience Labs. We can ensure your product is manufactured with the appropriate overages, and even help coordinate third-party testing.
For more information about our custom contract manufacturing capabilities, minimum order quantities, and more, call 855-492-7388 to speak with one of our knowledgeable specialists. Alternatively, complete our secure manufacturing price quote form to receive a free, no-obligation price estimate for your project.