There are over 29,000 different herbal products sold throughout North America. Over $5 billion is spent on herbal supplements every year in the U.S. but not all supplements contain what they market.
Supplements and the FDA
Herbal supplements are considered to be dietary supplements and are not regulated by the FDA. The FDA isn’t even “authorized to review dietary supplement products for safety and effectiveness before they are marketed.” It’s the responsibility of the manufacturer and distributors to make sure their products are safe, aren’t false or misleading, and that they comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations.
The only thing that the FDA does is take action against those who have misbranded, have not followed the regulations, and when the product is found to not be safe. This appears to only happen if the product is reported. Otherwise, dietary supplements are not regulated.
Supplements and Their Ingredients
When you buy a supplement you expect the herb listed to be present. However, this is not always true.
In 2013, a group of Canadian Scientist ran DNA testing on 44 bottles of supplements found in Canada and in the U.S. to find what ingredients were present in the supplements. They found that one-third of the tested supplement did not contain the plant the bottle advertised. Not only did they not contain the marketed plant, but they were filled with fillers such as rice, soy, and wheat, which were not listed as ingredients on the bottles. Many of the supplements were diluted, contained fillers, and included ingredients that weren’t even listed on the bottle.
Another test was done on Walmart, Target, GNC, and Walgreens brand supplements. They also used DNA testing on 24 bottles of supplements. They found that all but 5 of the 24 supplements contained DNA from plants that the bottle did not market. Some contained wheat, beans, and other plants. Walmart scored the lowest of the four companies. These companies did receive a cease-and-desist letter in 2015 demanding that these products be pulled.
Choosing Quality Supplements
Fillers, lack of regulation, and unlabeled allergens, how do you know what supplements are safe or contain what they market?
First, know that dietary supplements cannot be marketed saying that they can treat, diagnose, prevent, or cure diseases. Only drugs can make these claims which are evaluated and regulated by the FDA, unlike dietary supplements.
1. Look for Independently certified supplements
The U.S. Pharmacopeial Convention (USP) and the National Sanitation Foundation (NSF) are both great independent companies that evaluate the quality and ingredients of supplements and more. Supplements with these certifications are guaranteed to have the ingredients listed on the bottle and no secret, unlisted ingredients.
USP is a scientific nonprofit organization founded in 1820. Their drug standards are used not only in the U.S. but in more than 140 countries.
Their mission: “To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”
Participation in the certification program is voluntary and involves a GMP audit, product testing, and manufacturing documentation review.
USP’s Verification Program only verifies that supplements contain the ingredients stated on the label, in the stated amounts, and that they meet acceptable limits for contaminants such as heavy metals, pesticides, dioxins, furans, PCBs, and microbes. The program also verifies that the products are manufactured using safe, sanitary, and well-controlled procedures.
NSF is a nonprofit organization founded in 1944. They develop standards and test and certify products and systems.
Their Mission: To protect and improve global human health.
NSF will conduct random product testing to verify that the products still comply with the certification.
There are three main components of the NSF dietary supplements certification program:
- Label claim review to certify that what’s on the label is in the bottle
- Toxicology review to certify product formulation (we don’t test for efficacy)
- Contaminant review to ensure the product contains no undeclared ingredients or unacceptable levels of contaminants
2. Ask your Doctor
Always check with your doctor first before taking supplements. You can also ask them for recommendations for quality supplement brands.
Keep yourself safe and know what’s in your supplements by purchasing quality brands. Supplements are not regulated by the FDA but certification from third-parties like USP and NSF can help you find quality supplements.
–FDA Dietary Supplements
–FDA What is the difference between a dietary supplement and a conventional food?
–Herbal supplements: What to know before you buy
–FDA Dietary Supplements: What You Need to Know
–Herbal Supplements Are Often Not What They Seem