What the FDA’s New Ruling Means for Caffeine Supplements


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Most of us need a little boost from a caffeinated beverage to get through the day, whether that boost comes from coffee, soda or energy drinks. For those who want a pick-me-up from another source, nutraceutical companies have been happy to supply alternatives. In powders, liquids or tablets, there are plenty of ways to add a jolt to your day besides java. However, recent headlines about dangerous caffeine levels in supplements and subsequent action by the U.S. Food and Drug Administration (FDA) might have some manufacturers and consumers a bit worried.

What’s Safe

Odds are, your daily source of caffeine doesn’t present a health risk to you. According to Mayo Clinic, healthy adults can take in up to 400 milligrams (mg) of caffeine daily1. To gauge how much you take in, a cup of coffee has about 95 mg, a 12-ounce can of soda has between 34-55 mg and an energy shot (depending on the brand) can have about 75 mg. When taken in moderation, these do not present a health hazard.

Some dietary supplements happen to contain caffeine, but they aren’t purely caffeine. A perfect example of this is a supplement containing green tea extract. The amount of caffeine in these supplements is very different from brand to brand, but they may contain as low as 4 mg or as high as 160 mg per serving. If the packaging clearly tells consumers how much caffeine they’re ingesting, the caffeine in these supplements shouldn’t present a health risk.

What’s Dangerous

The FDA’s ruling doesn’t apply to the sources mentioned above. The FDA is concerned with highly concentrated or pure caffeine products, which contain an extremely high amount of caffeine in either a small amount of liquid or powder. Good things come in small packages, but that packaging also makes it easy to overdo it. Just a half cup of a concentrated liquid caffeine supplement can contain 2,000 mg of caffeine and a single teaspoon of a powdered caffeine supplement can contain 3,200 mg2. And since the FDA recommends only ingesting 200 mg of caffeine from these sources, a little goes a long way. Unfortunately, that long way leads to dangerous places.

Caffeine energizes you and makes you more alert. But you can have too much of a good thing. Surpass the recommended amount and that alertness turns into nervousness, irritability and restlessness. Go far enough and you’ll experience tachycardia, ventricular arrhythmia, seizures or even death. This is part of what prompted the FDA to take action — two otherwise healthy adults who died due to an excessive dose of caffeine from the very supplements we’ve been discussing. The FDA worries that requiring consumers to exactly measure out a small amount of liquid or powder could cause problems, especially if they do not have the tools to do so. For example, 1/16 of a teaspoon of a powdered caffeine supplement meets the 200 mg suggestion, but most consumers do not have a way to measure such a small amount.

Where’s the Line?

The FDA’s guidance on the matter acknowledges that certain “powdered [or liquid] caffeine product[s] sold in bulk could be permissible under the FD&C Act,” but generally speaking, these products are considered adulterated3. A big part of the concern is that these supplements are sold in bulk. Information that the FDA gathered online suggests that consumers tend to share the supplement among themselves, but this is part of FDA’s concern since it would mean most of the users wouldn’t have access to the warnings or instructions on the label. This is also why including some sort of scoop or measuring spoon is considered insufficient, since there would only be one which couldn’t be shared among other consumers. Basically, even if a company takes the following precautions, the FDA would still consider it adulterated under section 402(f)(1)(A):

  • The product specifies a serving size that is safe for human consumption.
  • A scoop/measuring spoon is provided that matches that serving size.
  • The product’s label includes a warning to not exceed the serving size.

There is middle ground here. A company manufacturing supplements that currently do not conform to this guidance can make a few tweaks to its formulation or packaging and become compliant. Since this will protect consumers as well, it’s in the company’s best interest to make these changes.

  1. Concern: Consumers must be extremely accurate when measuring out a dose.
    Solution: Selling the supplement in a solid dosage form, such as a tablet or capsule, or selling the powder in serving-size packets.
  2. Concern: The supplement is so concentrated that overdosing is likely.
    Solution: Bulk powders or liquids can be diluted to the point that a larger serving delivers the same amount of caffeine.

Making a Change

The solutions listed above may sound simple, but in practice they present manufacturers with their own challenges. Fortunately, the more automated a nutraceutical company’s processes are, the easier these changes are to make. An electronic quality management system (QMS) comes equipped with tools designed to make changes such as this easier.

The first challenge is re-writing a company’s standard operating procedures (SOPs). That in and of itself isn’t much of a challenge. However, making sure that the current version is the one in use is a challenge. Paper-based SOPs make it hard to track changes, distribute the current version and make sure all personnel are familiar with the current version. A QMS remedies these problems and allows for external parties to access the changes as well as onsite personnel. Changes can be tracked and electronic signatures allow users to see who made what change when. Since the SOPs are all kept in a centralized location, everyone is accessing the same version and by automatically archiving older versions, only the current version is used.

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Making sure everyone is trained on the new version is the next challenge. A well-connected QMS that offers robust training management capabilities can automatically send out notifications when employees need to review a new SOP. It can further allow managers to administer a test to make sure the SOP was read, or a manager can track how much time was spent reading the SOP.

One of the most common violations that the FDA encounters is that nutraceutical companies cannot show evidence that they conducted testing on the finished supplement to ensure its composition matches what is outlined in the SOPs. A bonus from using a QMS is that all documentation is easily tracked and compiled when needed. This makes audits or inspection by the FDA much smoother than it would be with a paper-based system.

The FDA’s new guidance shouldn’t make companies shy away from producing caffeine supplements. It should make them rethink the way they manufacture these supplements and adapt new processes that better protect consumers. These are big changes in how the product is packaged and, in some cases, how the product is formulated. To ease the transition, nutraceutical companies should use a QMS that is equipped to handle these changes.


References

  1. Mayo Clinic. “Caffeine: How much is too much?” March 8, 2017. https://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/caffeine/art-20045678
  2. Food & Drug Administration. “FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine.” April 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604485.htm
  3. Food & Drug Administration. “Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry.” April 2018. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf



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Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, Utah. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.