What Does the FDA Have to Say About Supplements?

Many people voice concern about the notion that supplements aren’t regulated by the U.S. Food and Drug Administration. While it's true the FDA doesn’t regulate vitamins and supplements in the same way the federal agency regulates food and prescription medications, the 1994 Dietary Supplement Health and Education Act (DSHEA) created a new regulatory framework for dietary supplements, including regulations about the safety and labeling of supplements.

Although dietary supplements do not need FDA approval before they are marketed to the public, under the 1994 act, manufacturers and distributors of supplements are responsible for ensuring the safety of their products, and must have evidence based on clinical studies or other research that supports any claims they make about what a supplement does or is designed to do.

The DSHEA also requires supplement manufacturers to properly label their products. Labels must include a complete list of ingredients and nutrition labeling that includes a “Supplement Facts” panel. The label must also provide a descriptive name of the product that clearly states it is a “supplement” as well as the name and address of the manufacturer, packer or distributor. Manufacturers are required to notify the FDA when introducing a “new dietary ingredient,” which requires the ingredient to be reviewed for safety before it hits the market. This is a process Kaneka Corporation went through when it brought its KanekaQH™ Ubiquinol to the market in 2006. Manufacturers also have to register with the FDA before producing or selling supplements.

Kaneka developed and patented KanekaQH™, the world’s first and only Ubiquinol available for use in supplements. Ubiquinol is the reduced, active antioxidant form of Coenzyme Q10 (or CoQ10), a nutrient your body naturally produces then converts into Ubiquinol. Your body needs Ubiquinol for its cellular energy production process. Ubiquinol also helps maintain the health of your heart, liver, kidneys and brain and can boost energy levels. As the most powerful known fat-soluble antioxidant, Ubiquinol can protect your cells, tissue and organs from damage caused by oxidative stress and free radicals.

CoQ10 supplements have been available for more than 30 years, but study after study has demonstrated that Ubiquinol is actually more effective than CoQ10, especially for anyone over the age of 30.As we age, our bodies become less efficient at converting CoQ10 to Ubiquinol. With Ubiquinol supplements, the conversion from CoQ10 has already been done outside your body, so the Ubiquinol is ready for immediate use. Every study to date shows that individuals can more easily absorb and use Ubiquinol than conventional CoQ10.

Today, there are many brands of Ubiquinol supplements on the market, but all of them use Kaneka’s patented Ubiquinol in their products. Although each manufacturer must follow FDA regulations regarding supplements, it’s up to you as the consumer to evaluate the individual brands to decide which is best for you.

So how do you determine which supplement, Ubiquinol or otherwise, is best for you? Read the label, familiarize yourself with the list of ingredients and check the “Supplement Facts” panel on the bottle or box. Kaneka QH™ Ubiquinol is the main ingredient in more than 135 brand-name supplements. Companies that make and sell Ubiquinol supplements include Nature Made, Nature’s Plus, Doctor’s Best and Puritan’s Pride. Several national retailers, including The Vitamin Shoppe, GNC and Trader Joe’s, also make and sell their own store brands of Ubiquinol supplements.

Ubiquinol supplements are widely available at pharmacies, vitamin shops and in the supplement aisle or health section of most grocery stores. When shopping, you should be aware that Ubiquinol is often labeled as “CoQ10 Ubiquinol” and is usually stocked on the same shelf or in the same area as conventional CoQ10 supplements. To avoid confusion, check the FDA-required Supplement Facts label on the bottle for “Ubiquinol (Kaneka QH™).” Authentic Ubiquinol products include the Kaneka QH logo, so you can be certain you are buying the right form of CoQ10.

The recommended daily maintenance dose of Ubiquinol is 100 mg per day, with some experts recommending 200-300mg a day for those who need it most. Many Ubiquinol supplements contain 100 mg per serving (i.e., per softgel or capsule), but check the amount on the Supplement Facts label to be sure as many brands now offer 200 or 300 mg softgels to reduce the number of pills you need to take. 

Although vitamins and dietary supplements do not need approval from the FDA before they are sold to the public, consumers can have confidence that the FDA has regulations for supplement manufacturers and distributors. Pay attention to the Supplement Facts label and other important information on the bottle to help make an informed decision about what supplements are right for you!

This article is for general educational purposes only and is not intended to be used as or substituted for medical advice.  Always seek the advice of your physician or qualified health care provider with any questions about your health or a medical condition.  Never disregard or delay seeking medical advice because of something you have read on the internet.