Formula Review: Stem Cell Serum - Texture, Skin Type Suitability, and FDA Registration
Question
I have a serum formula for anti-aging, hydration, and brightening containing the following ingredients:
- Apple Stem Cell Extract (AppleCell™)
- Pep®-Coll (Palmitoyl tripeptide-5)
- Natto Gum
- Creatine
- NAT-RIBOSE™
- Vitamin B3, Niacinamide (Safe-B3™)
- n-acetyl glucosamine (GlucoBright™)
- Preservative 1%
I have three questions regarding this formula:
- To make this a serum, do I need to add anything else?
- Is this formula suitable for all skin types and ages?
- Can this formula be registered with the FDA (อย.)?
Answer
Formula Review: Stem Cell Serum
Your formula includes several excellent active ingredients known for their benefits related to anti-aging, hydration, and brightening:
- Apple Stem Cell Extract (AppleCell™): Known for helping to slow down skin aging and promote a youthful appearance.
- Pep®-Coll (Palmitoyl tripeptide-5): A peptide that helps stimulate collagen production to reduce wrinkles and improve skin firmness.
- Natto Gum: Provides intense hydration, potentially more than Hyaluronic Acid, and offers gentle brightening effects.
- Creatine: Supports collagen, elastin, and keratin production, helps protect skin cells, boosts cell energy, and improves moisture levels.
- NAT-RIBOSE™: Helps increase ATP (cell energy) synthesis, improving skin elasticity and reducing signs of aging.
- Vitamin B3, Niacinamide (Safe-B3™): A versatile ingredient that reduces wrinkles, hyperpigmentation, strengthens the skin barrier, adds moisture (stimulates collagen/ceramide), and can help control oiliness. Suitable for acne-prone skin.
- n-acetyl glucosamine (GlucoBright™): Works with Niacinamide for whitening and dark spot reduction, stimulates Hyaluronic Acid, and provides gentle exfoliation.
These ingredients collectively target the goals you mentioned: reducing wrinkles, firming skin, brightening complexion, and being gentle.
Addressing Your Questions:
1. To make this a serum, do I need to add anything else?
Yes, you will need to add a thickening or gelling agent to achieve a serum texture. The current ingredients dissolved in water would result in a very liquid consistency. Adding a water-soluble thickener will give it the desired viscosity of a serum.
The staff also recommended adding PE-1 Aqua at 3%. This ingredient acts as a penetration enhancer specifically for water-soluble actives. Adding it could help the beneficial ingredients absorb into the skin more effectively. Note that PE-1 Aqua has an INCI name of Fragrance, but its primary function here is penetration enhancement.
2. Is this formula suitable for all skin types and ages?
Based on the ingredients and the staff's feedback, this formula is best suited for normal skin types.
- It contains hydrating ingredients like Natto Gum, Niacinamide, GlucoBright™, and Creatine, but it lacks significant emollients or occlusives typically needed for dry skin.
- While Niacinamide can help reduce oiliness, the formula does not contain specific oil-controlling ingredients, making it less ideal for oily skin.
- The ingredients target signs of aging (wrinkles, firmness, brightness), making it suitable for mature skin. The hydrating and brightening benefits could also be beneficial for younger skin. It is formulated to be gentle, which is good for sensitive skin, but individual reactions can always occur.
Therefore, while gentle, it's not universally optimal for all skin types (specifically very dry or very oily) but is generally suitable for normal skin and various age groups concerned with aging and brightening.
3. Can this formula be registered with the FDA (อย.)?
Registering a cosmetic formula with the FDA (อย.) depends on several factors:
- Permitted Ingredients and Concentrations: All ingredients used must be allowed for cosmetic use in Thailand and be within their maximum permitted concentrations.
- Preservative System: You listed "Preservative 1%". It is crucial to ensure the specific preservative used is permitted and that the total concentration in the final formula is within the regulatory limit. For example, if the preservative is Phenoxyethanol, the maximum permitted concentration is typically 1%. Natto Gum already contains 0.7% Phenoxyethanol as a preservative. If your added 1% preservative is also Phenoxyethanol, the total concentration would be 1.7%, which exceeds the limit and would prevent FDA registration. You would need to adjust the preservative system to comply with regulations.
- Safety and Stability: The final product must be proven safe and stable over its intended shelf life under normal storage conditions.
- Manufacturing Practices: The product must be manufactured in a facility that adheres to Good Manufacturing Practices (GMP).
- Labeling: The product labeling must comply with all FDA requirements, including listing ingredients correctly (using INCI names), providing usage instructions, warnings, manufacturer information, etc.
In summary, the formula can likely be registered if all ingredients are compliant, the preservative level is correct, and the product meets safety, stability, and manufacturing standards, along with proper labeling. The preservative concentration is a key point to verify for compliance.
Recommendations:
- Add a suitable water-soluble gelling agent (thickener) to achieve the desired serum texture.
- Consider adding PE-1 Aqua (3%) to enhance the penetration of the water-soluble active ingredients.
- Carefully review and adjust the preservative system to ensure the total concentration of each preservative falls within the regulatory limits for FDA registration.
- If targeting dry or oily skin specifically, consider adjusting the formula by adding appropriate moisturizing or oil-controlling ingredients.
Related Products Mentioned
Pep®-Coll (Palmitoyl tripeptide-5)
Safe-B3™ (Vitamin B3, Niacinamide)
GlucoBright™ (Acetyl Glucosamine)
Natto Gum Extract
NAT-RIBOSE™
PE-1 Aqua
Creatine 100