Ingredient
Safrole
A prohibition written widely enough to catch the plant, the tea made from it, and the derivatives someone might reach for instead.
- Also on labels as
- Oil of sassafras, Shikimol, Isosafrole
- Found in
- food, supplements
Part of Banned elsewhere · Medicines
Most prohibitions in this part of the regulation name a synthesised chemical. This one names a plant, and then works outwards from it, which makes it unusually instructive about how a rule is drafted to survive contact with the people it applies to.
The substance
The regulation describes it plainly: “Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, C 10 H 10 O 2. It is a natural constituent of the sassafras plant. Oil of sassafras is about 80 percent safrole.”
Natural constituent is worth pausing on. Nothing here was added by an industry. The prohibition is on a compound the plant makes.
The drafting is the interesting part
A narrow rule would have banned safrole. This one anticipates the workarounds and names them.
It covers food containing “any added safrole, oil of sassafras, isosafrole, or dihydrosafrole, as such”, so switching to a derivative does not help. And it reaches past the extract to the raw material: food containing those substances “e.g., sassafras bark, which is intended solely or primarily as a vehicle for imparting such substances to another food, e.g., sassafras tea, is deemed to be adulterated”.
The order it rests on was published in 1960, which places it a generation before most of the additive rules a label reader meets.
Where this touches a shopping decision
Not in the flavour aisle, where safrole has been absent since before most shoppers were born. Root beer in the United States has been made without it for decades, which is why the drink’s flavour is a construction rather than an extract.
It touches the herbal shelf. The regulation’s own example is a tea, and sassafras is still sold in various forms as a traditional preparation. A herbal product is not outside food law because it is traditional, and this is one of the clearer cases where a plant preparation is named in a prohibition rather than merely unapproved.
That is the general lesson of the supplements cluster: the rules that apply to a substance depend on what the product claims to be, and a tea is a food.
The limit of what is here
This page describes a prohibition and its scope. It does not describe a dose, a threshold, or a risk to a person, because the regulation states none of those and this site does not supply numbers its sources do not carry.
Hazard versus exposure is the guide for why that gap matters and why filling it with a guess would be the wrong kind of helpful.
Sources
- 21 CFR 189.180: Safrole US Food and Drug Administration, via eCFR · ecfr.gov Prohibits safrole, oil of sassafras, isosafrole and dihydrosafrole in food, and extends the prohibition to sassafras bark used as a vehicle, giving sassafras tea as the example.
- 21 CFR 189.1: Substances prohibited from use in human food US Food and Drug Administration, via eCFR · ecfr.gov States the grounds on which substances appear on the prohibited list, and that use of any of them adulterates the food.