I promised you the calculations validated by our scientific and quality assurance departments.
The recent Fresh Breath recall concerns a regulatory declaration issue. It is not a safety issue. No adverse effects have been reported.
Due to my rigorous approach, I myself initiated a recall when a received mixture did not exactly match the declared percentages.
Once again: this is about declaration compliance, not a health risk. It is appropriate to submit a new marketing authorization application to reflect the exact percentages.
I prefer to recall and correct immediately rather than leaving room for doubt—or misinterpretations.
Some articles choose to conflate this recall with events dating back to 2018, unrelated to our current products. Merging distinct facts can create a misleading perception. I believe in fair, contextualized, and responsible information.
Maison Jacynthe has always acted with high standards, transparency, and integrity. Always.
Here is the promised calculation regarding methyl eugenol.
Prevention & Safety: We immediately point out that the issue is primarily a regulatory precaution and classification measure. The adjustment we made meets these requirements, and no acute toxic effect is associated with the product at current doses. This natural molecule is on Health Canada's watch list, and its use is regulated. To date, there is no indication of an immediate danger to consumers. This approach simply aims to ensure safety and prevent any potential long-term risk.
Methyl Eugenol: Understanding the Numbers and Regulatory Frameworks.
Two different frameworks = two different logics
Cosmetic Framework (Cosmetic Ingredient Hotlist)
The limit for methyl eugenol content in rinse-off cosmetic products and oral hygiene products is 2 ppm or 0.0002%.
The concentration is evaluated in the product itself, not the absorbed dose based on body weight.
If the formula exceeds 2 ppm, it is considered non-compliant, even if the amount actually absorbed is very low.
Fresh Breath falls into the cosmetic category. For Fresh Breath, Health Canada measured a methyl eugenol content of 152 ppm (equivalent to 152 mg/kg or 152 µg/g in the formula).
This exceeds the cosmetic limit of 2 ppm applicable to the formula as classified in the rinse-off cosmetic/oral hygiene category.
In the Canadian regulatory framework, the evaluation focuses on the concentration in the product as formulated and marketed.
When the product used is diluted, the applied concentration is reduced, but regulatory compliance remains linked to the registered formula.
We have already made adjustments to our formula as a preventive measure aimed at safety and regulatory compliance related to classification.
Ingestion Framework (NHP - Natural Health Product) - the rule is no longer the same.
For NHPs, the exposure limit is 200 µg per kg of body weight per day.
Here, the dose actually consumed is calculated according to weight. Without commenting on what is acceptable or safe, I invite you to see for yourself the relationship to the different specifications or ways of approaching and calculating (leaving the interpretation to professionals in the field and researchers):
For a person weighing 57 kg (126 lbs) - me (who has been consuming Fresh Breath and Cold & Flu Solution for 20 years) this represents:
57 kg x 200 µg/kg = 11,400 µg per day (11.4 mg).
What does one drop represent, concretely?
When pure clove essential oil is analyzed, we obtain:
480 ppm = 0.048% methyl eugenol
Knowing that one drop of essential oil weighs approximately 40 mg:
For one drop of pure clove essential oil (e.o.):
40 mg × 0.048% ≈ 19 µg
Three drops of pure e.o. ≈ 57 µg
Compared to my personal threshold of 11,400 µg per day, this represents less than 0.5% of the daily threshold.
Pure laurel essential oil can contain approximately 0.1% to 2% methyl eugenol, depending on origin and batch.
For illustrative purposes:
- 1 drop of pure essential oil (≈ 40 mg) containing 1% methyl eugenol would contain approximately 400 micrograms.
- When an essential oil is incorporated into a formula, it is generally done at a variable level, for example at 5%, 10%, or 20%. Thus, the quantity per drop of the mixture decreases proportionally.
Cold & Flu Solution (20% clove in the formula)
One drop of the mixture ≈ 40 mg
Clove = 20%
20% x 40 mg × 0.048% ≈ 3.8 µg of methyl eugenol per drop
Three drops ≈ 11 µg
This represents approximately 0.1% of my personal daily threshold.
Why the confusion?
- Fresh Breath is classified as a cosmetic/oral hygiene product, so the 2 ppm limit applies.
- Cold & Flu Solution is a natural health product, so the µg/kg/day logic applies.
The two frameworks use different units:
ppm = concentration in the product
µg/kg/day = absorbed dose based on body weight
Does methyl eugenol accumulate?
No.
According to toxicokinetic evaluations published by IARC (WHO) and the National
Toxicology Program (US)*, methyl eugenol is rapidly metabolized and eliminated by the body, mainly via the liver and urine. The available data do not describe a bioaccumulation phenomenon comparable to that observed with persistent substances.
Restrictions come from animal studies at very high and chronic doses, with significant safety margins. This is the standard way health authorities assess risks to human health.
Conclusion
Pure methyl eugenol is not authorized (this refers to the ISOLATED natural component, a chemical molecule - hence the mention of risk in the chemical category)
Its natural presence is regulated.
Fresh Breath exceeds the 2 ppm limit established by Health Canada for a cosmetic/oral hygiene product, which constitutes a regulatory issue that we managed very quickly! Even before a pan-Canadian investigation into the presence of methyl eugenol in cosmetics addressed MJ, I removed clove & laurel essential oil from the formula to comply with the regulatory framework related to its cosmetic classification.
For NHPs, the standards are different, and our Cold & Flu Solution product, even at 20% clove, represents an extremely low actual exposure per drop and fully complies with Health Canada's requirements.
Three drops of a 20% clove mixture ≈ 11 µg, very far from my personal threshold of approximately 11,400 µg per day.
Methyl eugenol does not accumulate in the body.
The question is therefore primarily a regulatory precaution and classification measure, and not a question of acute toxicity at the doses mentioned. No danger is identified.
Scientific References
International Agency for Research on Cancer (IARC).
Methyl eugenol. In: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 101: Some Chemicals Present in Industrial and Consumer Products, Food and Drinking-water. Lyon, France: IARC; 2013.
(See section Toxicokinetics and Metabolism.)
National Toxicology Program (NTP).
Toxicology and Carcinogenesis Studies of Methyl Eugenol (CAS No. 93-15-2).
NTP Technical Report Series No. 491. U.S. Department of Health and Human Services, 2000.
(Data on absorption, metabolism, and excretion.)
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