Dietary supplements are a part of many Americans’ daily health regimen. More than 2/3rds of American adults and 1/3rd of children take supplements. Many people, especially pregnant women, take supplements on the advice of a health professional.
Yet, it seems not a week goes by without a news report that either questions the quality of dietary supplements or points to adverse events caused by them. Critics of the industry like to say supplements are unregulated, but that is not true. Dietary supplements are regulated; they are just not regulated like drugs.
Dietary Supplements are Regulated Like Foods, Not Drugs
Perhaps the confusion is understandable; dietary supplements look like medicines, are sold near medicines, and claim to support health. However, in terms of government oversight, dietary supplements are actually foods.
Unlike drugs, supplement manufacturers do not face market access restrictions (except in the case of a new dietary ingredient) or post market review. Supplement manufacturers do not have to prove to the Food and Drug Administration (FDA) that their products are safe or effective to be able to sell them. Instead, they are free to sell their products with the understanding that they have conducted their own tests and will have that information available if challenged by the FDA.
Many dietary supplement manufacturers adhere to good manufacturing practices as required by the FDA, but, there are some bad actors in the market that ignore laws aimed at protecting consumers because their only goal is to make as much profit as possible.
When Shopping for Supplements, Look for USP on the Label
So, how can a consumer identify and purchase quality supplements? One way is to look for the letters “USP” on the label. For over a century, manufacturers of medicines, vitamins and minerals have included the letters “USP” on their product labels to indicate they follow the quality standards set by the U.S. Pharmacopeia.
Unlike medicines, where compliance with USP identity standards is required by law, Congress made adherence to USP standards voluntary for dietary supplement manufacturers. Consequently, it is not as common to see the letters “USP” on dietary supplement product labels. Yet, some manufacturers do follow USP standards for dietary supplements and label their products “USP”.
Today, you are more likely to see the USP Verified Mark on the label of dietary supplements. USP offers participation in a voluntary third party quality assurance and testing program to manufacturers of dietary supplement ingredients and products. Manufacturers who participate do so to demonstrate the quality of their products by going above and beyond the current regulatory requirements. Products that successfully meet the stringent requirements of the USP Verification Program are awarded the distinctive USP Verified Mark.
The USP Verified Mark on the label indicates:
- What’s on the label is in the bottle;
- Ingredients listed on the label are present in the declared potency and amounts;
- The product does not contain harmful levels of specified contaminants;
- The product will break down in the body within a specified amount of time;
- The product is made using safe, sanitary and well-controlled manufacturing practices according to FDA and USP guidelines.
Leading Hospital Recommends USP Verified Supplements
Concerns about the quality of dietary supplement prompted the Children’s Hospital of Philadelphia to refuse to administer dietary supplements to patients unless they have been subject to third party quality testing. The hospital specifically recommends patients look for “USP Verified” supplements.
More recently, researchers from leading medical schools and Boston Children’s hospital have called on states to increase regulation of dietary supplements citing lax federal regulations. Until then, USP quality assurances are available to you where you shop.
Look for “USP” or the USP Verified Mark when shopping for dietary supplements. You can also ask your pharmacist for dietary supplements with “USP” or the USP Verified Mark on the label.
For more information about the USP Verified Mark visit www.uspverified.org
John Atwater is Senior Director of USP Verification Programs