What makes a microsphere FDA-approved?
In order to tell whether the microsphere can be used in cosmetics, food, or medical devices it is important to look at the raw materials that are incorporated into the microsphere during manufacturing process.? For example, unpigmented or clear polyethylene microspheres supplied by Cospheric in sizes from 10 micron to 1000 micron meet the quality requirements of the US FDA as specified in 21 CFR 172.888 and 21 CFR 178.3720.? Specific grade of polyethylene used in manufacturing of these microspheres is? FDA-approved for food applications in chewing gum base, on cheese and raw fruits and vegetables, and as a defoamer in food.
Color additives are subject to a strict system of approval under U.S. law (FD&C Act), sec. 721; 21 U.S.C. 379e. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. If a product contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:
- Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.
- Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
- Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
- Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.
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