Welcome to part two of “How to Really Read a Supplement Label.” In part one, we covered the different parts of the label and the information that must be included in the label. In part two we’ll look at the types of claims that might be included on a label and how they are regulated.
Claims are usually short statements that say how the supplement can benefit you. They serve two purposes: to provide information about the product and to help promote the product so you’ll buy it. Claims are not required to be included on the label, but when they are, there are regulations specifying how they can be used. Keep in mind (as discussed in “A Common Misconception about Herbal Supplements”) that supplements are regulated as a special kind of food and not as a drug.
The Three Types of Claims
The first type of claim is one that doesn’t need pre-approval or to be authorized by the FDA in order to be used on a supplement label. In the table below are the different claims or statements that fall into this category.
|Types of claims||Definition||FDA says||Examples|
|Structure/function claim||Describes the role of a substance intended to maintain the structure or function of the body.||Does not need pre-approval by the FDA to be included on a supplement label||– Helps maintain intestinal flora – Helps promote urinary tract health – Supports the immune system – Improves memory|
|General well-being claim||Describe general well-being from consumption of a nutrient or dietary ingredient||Does not need pre-approval by the FDA to be included on a supplement label||– Contributes to general good health- Helps you feel good|
|Nutrient deficiency disease claim||Describes a benefit related to a classical nutritional deficiency disease||Does not need pre-approval by the FDA to be included on a supplement label, but must include statement on how widespread the disease is in the United States||Vitamin C helps reduce the risk of scurvy. Scurvy affects x% of people in the USA.|
While these claims don’t need to be pre-approved for use, a company must
- Have relevant evidence that verifies that the statement is truthful and not misleading.
- Notify the FDA no later than 30 days after the product first goes on the market that the statement is being used.
- Include the disclaimer statement on the label/container adjacent to or linked by a symbol to the claim. The disclaimer must say (depending on how many claims are being used), “This/These statements has/have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The second type of claim is one that must be pre-approved by the FDA before being used on a supplement label.
|Types of claims||Definition||FDA says||Examples|
|Health claim||Describes the effect a substance has on a disease or health related condition||Must be authorized by the FDA to be included on a supplement label. Claim must be supported by significant scientific agreement.||– (Supplement) reduces the risk of (disease) – (Supplement) provides relief from symptoms associated with (health related condition)|
|Qualified health claim||Supported by less scientific evidence than an authorized health claim, but still meets the rest of the general requirements for a health claim||Must be pre-approved by the FDA for use. Recommends that the claim be accompanied by a disclaimer (or otherwise qualified) to explain the level of the scientific evidence supporting the relationship so that consumers are not misled by the nature of the evidence.||– Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive.|
For a claim to be pre-approved for use as a health claim, it needs to meet what’s called a significant scientific agreement (SSA) standard. Basically that means that with all of the publically available relevant, reliable scientific evidence taken into consideration, there is significant agreement among qualified experts that the claim is supported by the evidence. If approved, the claim needs to be accompanied by qualifying language that is provided by the FDA.
Last but not least, we have the type of claim that can never be used for a herbal supplement.
|Type of claim||Definition||FDA says||Examples|
|Disease claim||States that the product or ingredient(s) can diagnose, cure, mitigate, treat or prevent disease||Must be pre-approved by the FDA to be included on a label. Supplements cannot include disease claims on their label.||– Protective against cancer – Lowers cholesterol – Treats heart disease|
Enforcement for Claims
The FDA works together with the Federal Trade Commission (FTC) in evaluating claims on supplements. The FTC is a governmental agency whose responsibility is to prevent business practices that are anticompetitive or deceptive or unfair to consumers. The FTC has oversight for claims used in supplement advertising (e.g. print and broadcast ads, internet advertising) while the FDA oversees the regulation for claims included in supplement packaging, product inserts and point-of-sale information.
The FDA can evaluate claims individually and all claims together as a whole for a product to determine if the manufacturer is abiding by the regulations. The FDA can also look at the expressed benefit as well as the implied benefit of the claim. If the FDA determines that a product’s claims “cross the line,” the product can then be considered misbranded and in violation of the regulations. However, the FDA must be able to prove that claims are unsubstantiated before they can take action. If they do so, the company can then be subjected to warning letters, product seizures and mandatory recalls.
So What’s a Consumer to Do?
The types of claims typically allowed on herbal supplements talk about maintaining and supporting the healthy function of the body. Claims that typically aren’t allowed refer to treating and preventing diseases in the body. I say typically because when you dig into the regulations, a lot of how the FDA comes to its determination about claims is ‘it depends on the context.’ Bottom line – if you see an herbal supplement that talks about curing or preventing a disease, a red flag should go up in your head.
If you research the herb(s) you’re looking for before you go shopping, the claims most likely won’t provide you with any information you don’t already know. If you choose not to research beforehand, you may be relying on the claims to help you decide on your purchase. If that is the case, remember that even with the regulations, there is very little to stop a company from putting out a supplement with inaccurate or misleading claims about its product.
Consumers have a way to report directly to the FDA any issues they have with reactions to an herbal supplement or concerns about the safety or quality of a supplement. It’s called the Safety Reporting Portal (SRP) and you can learn more about it here. If you feel that a herbal supplement has been advertised falsely, you can report it directly to the FTC’s Complaint Assistant and also to your state Attorney’s General office. Reports from consumers can help alert the FDA and FTC to issues in the marketplace.
Next article – Types of Herbal Preparations
Links to Learn More
- FDA website – Health Fraud for Consumers – Consumer updates on health fraud, includes information for supplements. Also check out the “Protect Yourself” menu on the right hand side of the web page for more information
- FDA website – RSS feed on tainted dietary supplements
- FTC website – Supplement Marketers Will Relinquish $1.4 Million to Settle FTC Deceptive Advertising Charges
- FDA website – Guidance for Industry: A Food Labeling Guide – Information on the different kinds of claims
- FDA website – Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final – Detailed information on what the FDA looks for in scientific evidence for health claims
- Congressional Research Service – Regulation of Dietary Supplements, May 6, 2013