FDA Clinical Study Sounds Alarm for CBD Cosmetics Industry

A landmark clinical trial led by the U.S. Food and Drug Administration (FDA) has raised significant safety concerns for the CBD cosmetics industry. This randomized controlled trial (RCT), published on July 7, 2025 in JAMA Internal Medicine, confirms for the first time that commonly used doses of Cannabidiol (CBD) by consumers may lead to elevated liver enzymes in healthy adults. Meanwhile, global CBD regulatory policies are also tightening.

This is the first time that an authoritative institution has conducted a placebo-controlled RCT on "over-the-counter (OTC) dose" of CBD since its widespread use in skincare, beauty, and health products, providing empirical evidence for a market long lacking safety data. The study also observed elevated eosinophils in some participants, suggesting potential immune reaction risks. Although no clinical liver damage was detected, the research team cautioned that CBD to not be absolutely safe as advertised, especially in the case of long-term use at moderate doses.

A total of 201 healthy adults aged 18 to 55 were included in the trial, using a double-blind, randomized, placebo-controlled design. CBD was administered at a dose of 5 mg/kg/day, divided into two oral doses (2.5 mg/kg/time), for 28 days. The median weight of the subjects was 79.4 kg, and the calculated average daily intake dose was approximately 397 mg, which is basically consistent with the dosage range for self use of CBD essential oil and beauty products purchased by most consumers in the U.S. on the market.

While prescription drug Epidiolex demonstrated liver enzyme risks at high doses (25 mg/kg/day), safety data for medium-to-low long-term doses (200–400 mg/day) were previously absent. However, more and more consumers in the market are consuming 200 to 400mg of CBD daily, but there is a lack of clear risk guidelines. This study is filling this gap.

The experimental results showed that among 151 CBD recipients, 8 (5.6%) developed ALT/AST >3× upper limit of normal (ULN) during the third to fourth week of use. Among them, 5 cases had peak levels exceeding 5 times ULN, 2 even exceeded 10 times ULN, and the highest was 18 times. One case reported mild abdominal discomfort symptoms.

Seven individuals with elevated liver enzymes were accompanied by elevated eosinophils, suggesting that the metabolism of CBD may trigger a hepatitis-like stress process. All abnormal indicators gradually recovered to baseline levels within 1-2 weeks of discontinuation, without causing clinical liver injury.

Meanwhile, there was no significant difference in the impact of CBD on the endocrine system. The changes in Testosterone and Inhibin B in males, as well as Thyroid Hormone in all subjects, were similar between CBD and placebo group.

Several European countries have also begun to tighten their regulatory authority over CBD.

In February 2025, the Portugal National Authority of Medicines and Health Products (Infarmed) recalled many cosmetics containing CBD, including face creams, essential oils, BB creams, mascaras and lipsticks. In April, the French Agency for Food, Environment and Occupational Health and Safety (ANSES) proposed classifying CBD as "Reproductive Toxicity Category 1B" under CLP regulations, which may damage fertility, harm fetuses, and potentially affect breastfed infants.

The UK has adopted a relatively balanced regulatory strategy. The UK Government Chemist has developed analytical limit guidelines for controlling Cannabinoids, allowing the use of CBD under specific conditions but requiring strict control over the levels of psychoactive Cannabinoids. In 2023, the UK Food Standards Agency significantly reduced the recommended daily intake of CBD from 70 mg to 10 mg.

In contrast, the China National Medical Products Administration (NMPA) explicitly prohibited the use of ingredients including CBD, industrial hemp leaf extract, and seed oil in cosmetics as early as 2021, removing them from the "Catalogue of Used Cosmetic Raw Materials". Hong Kong, China followed closely and listed CBD as a dangerous drug in February 2023, with a maximum sentence of 7 years in prison and a fine of 163,000 US dollars. South Korea has also followed up with similar bans in recent years, prohibiting the import of cosmetic ingredients containing CBD.

Currently, CBD remains legal only in non-drug products in the U.S., Canada, and some European countries, provided that the Tetrahydrocannabinol (THC) content is below 0.3%.