The Short Answer: No, Lemme Gummies Are Not 'FDA-Approved'
The direct answer is no, Kourtney Kardashian's Lemme gummies are not FDA-approved. This is consistent with how the U.S. Food and Drug Administration (FDA) handles all dietary supplements, as they do not approve them for safety or effectiveness before they are sold. Lemme includes the standard disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease".
Understanding the FDA's Role: Drugs vs. Dietary Supplements
The FDA applies different regulatory standards to drugs and dietary supplements.
- Drugs require rigorous pre-market approval, including clinical trials to demonstrate safety and effectiveness.
- Dietary Supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), treated more like food. Manufacturers are responsible for ensuring product safety and truthful labeling. The FDA primarily acts after a product is on the market if it is found to be unsafe or mislabeled.
Lemme: A Look at the Brand and Its Products
Kourtney Kardashian Barker's Lemme is a wellness brand selling various gummies and capsules for different health goals like sleep and gut health. The brand emphasizes using "clinically-studied" ingredients and avoiding certain artificial additives. Production facilities may be cGMP certified, which relates to manufacturing quality standards, not an FDA endorsement of health claims.
Controversies and Criticisms
Lemme has faced scrutiny and lawsuits. Class-action lawsuits in 2025 alleged false advertising of the "GLP-1 Daily" supplement as an alternative to FDA-approved weight-loss drugs. Health experts have also questioned the effectiveness of products like 'Lemme Purr' and pointed out potential issues with ingredients in 'Lemme Debloat' and low effective doses in 'Lemme Matcha'.
Drug vs. Dietary Supplement Comparison Table
| Feature | Prescription Drugs (e.g., Ozempic) | Dietary Supplements (e.g., Lemme) |
|---|---|---|
| FDA Pre-Market Approval | Required; must prove safety and efficacy through clinical trials | Not required |
| Intended Use | To diagnose, treat, cure, or prevent a specific disease | To supplement the diet; cannot claim to treat a disease |
| Efficacy Review | FDA evaluates clinical trial data to confirm effectiveness | Manufacturer is responsible for claims; FDA does not evaluate efficacy before sale |
| Safety Standard | Proven safe before being sold to the public | Manufacturer is responsible for safety; FDA monitors for adverse events after it's on the market |
| Label Disclaimer | N/A | Must include "This statement has not been evaluated by the Food and Drug Administration" |
Conclusion: Consumer Awareness is Key
Lemme gummies are not FDA-approved, although they may be made in facilities adhering to FDA manufacturing guidelines (cGMP). Consumers should be critical of health claims, especially with celebrity-endorsed products. Always consult a healthcare professional before adding any new supplement to your routine.
For more information directly from the source, you can visit the FDA's page on Dietary Supplements.
