Label Red Flags: Miracle Claims and Undeclared Ingredients

If you may have been harmed, start here

If you have side effects from a supplement, NCCIH advises stopping the supplement and contacting your health care provider. [1] Do not stop or change a prescribed medicine on your own; ask the prescriber. For severe symptoms such as trouble breathing, chest pain or fainting, call 911 (US). If a child may have swallowed a supplement, call Poison Help at 1-800-222-1222 (US) or 911; see poisoning: what to do first and, outside the US, Poison Help by country.

FDA says you or your health care provider can report a suspected adverse event through its Safety Reporting Portal. [2] Keep the product and label.

Why red flags matter

FDA does not have the authority to approve dietary supplements before they are marketed. [2] It also does not test them before sale. [2] Because of that, the label and ad are what you have to go on, and some products carry ingredients that are not on the label. This page covers US sources from FDA and NIH. Rules in other countries are not described in the sources we read.

Red flags in claims

Red flags on the label itself

• No maker named. US labels must carry the name and place of business of the manufacturer, packer or distributor. [2]
• No Supplement Facts panel or ingredient list. FDA lists a Supplement Facts panel (with some exceptions for small products) and an "Other Ingredients" list as required label items. [2] See the Supplement Facts panel.
• Blends that hide every amount. A blend limits what you can check; see proprietary blends explained.

Undeclared ingredients

FDA says hidden ingredients are often prescription drug ingredients, banned substances or harmful chemicals, and that under federal law products must list their ingredients accurately and cannot contain hidden drug ingredients. [4] NCCIH says products promoted mainly for weight loss, sexual enhancement and bodybuilding may contain prescription drugs not allowed in supplements or other ingredients not listed on the label. [1] It adds that FDA has found drugs such as the anticoagulant warfarin and the anticonvulsant phenytoin in products sold as supplements. [1]

1. How common were FDA warnings about adulterated supplements?

   Analysis of FDA's own warning database; shows warnings, not how common tainted products are overall

   A JAMA Network Open study counted 776 adulterated supplements identified by FDA from 2007 through 2016 [5]

2. What kinds of products?

   Same

   Most were marketed for sexual enhancement, weight loss or muscle building [5]

3. Does it continue after warnings?

   Same

   The authors said active pharmaceuticals continue to be identified, especially in sexual enhancement and weight-loss products, even after FDA warnings [5]

4. Do labels match contents?

   Summaries by NCCIH of single studies of one ingredient

   NCCIH reports a 2017 test of 31 melatonin supplements in which most amounts did not match the label [6]; and a 2023 study in which 22 of 25 melatonin gummies were inaccurately labeled [6]

5. Do athlete products match?

   Narrative review; sports products

   A narrative review of 16 studies found labeling differed from actual amounts [7]

One example FDA gives: laboratories found hundreds of weight-loss products, illegally marketed as supplements, that contained sibutramine, a drug later withdrawn after studies linked it to heart attack and stroke risk. [3] The JAMA authors noted that hidden drugs can cause serious harm through misuse, overuse or interaction with other medications. [5]

FDA's Health Fraud Product Database includes unapproved products subject to FDA health fraud violations, but FDA says it covers only a small fraction of such products and that absence from it does not mean a product is safe. [8][4]

Who should be most careful

People who take prescription medicines are pregnant or breastfeeding, have kidney or liver disease, are older, are giving a product to a child or are scheduled for surgery should ask a clinician or pharmacist before using products in the high-risk categories above. FDA advises consulting a health care professional before using any supplement. [2] See medication interactions.

What to do

• Ask a pharmacist to look at the label; bring the bottle.
• Contact the maker if something is unclear; FDA recommends this for more information than the label provides. [2]
• Read unsafe products and warnings, contamination, adulteration and recalls and quality testing and certifications. Testing marks check identity and contaminants; they do not prove a product works.