Have 5-hour ENERGY® shots been approved by the FDA?

Fact: No, they haven’t because 5-hour ENERGY® shots don’t need to be approved by the FDA.

The Food and Drug Administration, otherwise known as the FDA, is a facet of the US Department of Health and Human Services, and regulates dietary supplements, drugs, food, tobacco, and medical devices.

Many products exist in our daily lives aren’t FDA approved. It doesn’t mean that these products are unhealthy or “bad.” It only means that the US Department of Health and Human Services doesn’t require those specific items to be approved by the FDA to be sold or manufactured. This applies to plenty of everyday products: most food products don’t require FDA approval, nor do any dietary supplements, which 5-hour ENERGY® is categorized as.

The truth is, no existing dietary supplements are actually “approved” by the FDA, per se. (That includes items like multivitamins and probiotics) However, the fact that these items are not FDA approved does not mean that they aren’t heavily regulated—quite the contrary. All of our energy shots are stringently regulated by the FDA. In fact, they must comply with a regimented list of guidances and regulations.

What sort of regulations does 5-hour ENERGY® comply with?

5-hour ENERGY® shots are regulated by the FDA per the Dietary Supplement Health and Education Act of 1994, otherwise known as DSHEA. According to DSHEA, dietary supplements cannot contain anything that may have a “significant or unreasonable risk of illness or injury” when the supplement is used as instructed on the label. As of 2007, FDA rules also require the manufacturers of all dietary supplements to adhere to the Good Manufacturing Practices standard.

In order for all dietary supplements (including 5-hour ENERGY® products) to be distributed in the US, the products must:

  • Be produced in a quality manner
  • Be free of any contaminants or impurities
  • Be labeled accurately, with the actual ingredients in the product

Is there a correct amount to take?

For moderate energy, try taking half a bottle. For a fully maximized feeling, take the whole thing. While it’s okay to take two in one day, it’s highly encouraged to space them out between a few hours. It’s recommended not to exceed more than two bottles.

Do I need a doctor’s prescription to try 5-hour ENERGY® shots?

No, you don’t! 5-hour ENERGY® shots are available at most grocery stores, gas stations, pharmacies and superstores.

5-hour ENERGY® shots are shelf stable; they don’t require refrigeration until after opening. This makes them a great item for your bag or as a secret weapon in your work drawer. Once opened, 5-hour ENERGY® shots should be refrigerated and consumed within three days of opening.

Can anybody try 5-hour ENERGY® shots?

If you are undergoing any treatments, taking medications or have any physical conditions, it’s always a good idea to consult with your doctor before trying energy shots, or any dietary supplements. We do caution that 5-hour ENERGY® is not recommended for children, pregnant or nursing women.

Are you tired of feeling tired? Get the energy you need in a simple sip. Try 5-hour ENERGY® shots today!


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