Abstract

One of the biggest differences between drugs and cosmetics is the amount of information available to determine the constituents of the product. Drugs are explicitly labeled with the number of milligrams contained in the pill. Tight quality control is enforced globally by government regulatory agencies to insure that manufacturers adhere to ingredient purity and formulation accuracy. While there are many rules that apply globally to cosmetics, dose is an issue that has not been felt to be pertinent. Now with the development of active cosmetics, better known to dermatologists as cosmeceuticals, the amount of the active ingredient in the formulation has become more important. It is necessary to recognize that the concept of dose is foreign to cosmeceuticals because cosmeceuticals is a regulatory unrecognized term and unrecognized category in the United States. Many cosmeceuticals use botanical ingredients to provide skin benefits such as antioxidant, anti-inflammatory, emolliency, and moisturization. While cosmetics are required to disclose ingredients in order of decreasing concentration, it is not possible to determine the exact amount of any individual ingredient. Even the cosmetic manufacturer may not know the exact concentration and type of catechin in a green tea extract. Raw material suppliers develop and manufacture extracts, but characterization is difficult, given the variability of substances grown in an outdoor environment. The amount of sun, water, and soil nutrients can affect the amount of catechins present in a green tea. Further, the location of the farm and the season of harvesting can have additional effects. It would be challenging to standardize plant materials in the same manner as drugs. It is my belief, however, that cosmeceuticals cannot scientifically advance until the dose is better characterized and standardized. The development of plant bioreactors has made the ability to determine the “dose” for plant extracts within reach. Plant bioreactors use stem cells as living machines to generate botanicals in a controlled environment allowing more accuracy in the characterization of these plant materials. Stem cells are pluripotential cells that can differentiate into many different structures derived from many different plant parts including berries, leaves, stems, twigs, and roots. Antioxidant botanicals are commonly derived from plant leaves, as the leaves are the site of photosynthesis and require excellent oxidative stress protection. Plant materials obtained from outdoor cultivation may contain a variety of contaminants to include heavy metals, pesticides, and fungal toxins. When the plant material is concentrated, so are the contaminants. One of the biggest concerns with frequent green tea consumption is the possibility of pesticide intake, as pesticides are used to prevent leaf damage in the fields. It is not possible to remove the pesticides completely from the leaves, and tea represents a concentrated use of the dried leaves. Utilizing stem cells eliminates this type of concern by allowing the plant material to grow under controlled laboratory conditions increasing purity. Stem cell-derived materials also have greater consistency of contents. The plant materials are cultured under optimal conditions to yield a more standard composition than those grown outdoors that may vary based on weather, soil condition, fertilizer application, etc. Consistency is key to obtaining botanical materials that have a standardized dose of ingredients. This is an important step in moving the science of cosmeceuticals forward. This new technology will be very important to cosmetic dermatology as active cosmetics advance in their efficacy and safety. Only through this type of ingredient development can dermatologists better understand how much patients are getting by using botanical extracts in skin care products.

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