Hemp seed lip balms fall under federal oversight, but not in the same rigorous way as pharmaceuticals or medical products. In the United States, they are categorized as cosmetics, meaning they are regulated by the Food and Drug Administration (FDA) primarily after entering the market. Manufacturers, not the agency, bear the responsibility for ensuring their safety, proper labeling, and the accuracy of any claims made. Unlike drugs, cosmetics do not require pre-market approval from the FDA, except for certain color additives. Therefore, products marketed as “FDA-approved” lip balms are often misleadingly labeled.
Recent legislative changes have increased oversight. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expanded the FDA’s authority over cosmetics for the first time since the 1930s. Under this new framework, cosmetic manufacturers are required to register their facilities, list their products, maintain safety documentation, report serious adverse events, and follow forthcoming Good Manufacturing Practice (GMP) regulations. For hemp seed lip balm makers, this shift introduces higher expectations for transparency, manufacturing standards, and safety compliance.
The legal standing of hemp itself also plays a role. The 2018 Farm Bill legalized hemp by removing it from the federal definition of marijuana, provided that it contains less than 0.3% delta-9 THC. Hemp seed oil, a common ingredient in lip balms, meets this definition and does not produce psychoactive effects. While this legislation made it easier for companies to use hemp-derived ingredients, it did not exempt them from cosmetic regulations or guarantee safety approval. Manufacturers still must ensure their formulations meet cosmetic labeling and safety standards under FDA guidelines.
The area where regulation becomes particularly strict is in marketing and product claims. If a hemp seed lip balm is advertised to “heal cracked lips,” “treat eczema,” or “repair cold sores,” those claims imply therapeutic benefits and move the product into the drug category. Unless a product meets an established over-the-counter (OTC) monograph, these claims can result in the product being classified as an unapproved drug. The FDA and the Federal Trade Commission (FTC) have issued numerous enforcement actions and warning letters to companies that promote unsubstantiated health claims for hemp-derived cosmetics or topical products.
Aside from marketing claims, hemp seed lip balm manufacturers must also ensure accuracy in labeling and ingredient lists. The product must be safe for consumer use, free from harmful contaminants, and compliant with all applicable labeling requirements. Under MoCRA, companies are now expected to maintain adverse event reports and be prepared for potential product recalls.
In short, hemp seed lip balms are regulated under the same framework as other cosmetic products—through manufacturer accountability, post-market monitoring, and claim enforcement. They are not pre-approved by the FDA, but companies must adhere to strict labeling and marketing rules. The greatest regulatory risk lies not in the ingredient hemp seed oil itself, but in how the product is marketed to consumers.
Learn More: Hidden Additives: What to Avoid in Hemp Seed Lip Balms