The National Academies of Sciences, Engineering, and Medicine issued a report in August, titled “Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health,” recommending that the U.S. Environmental Protection Agency conduct an ecological risk assessment (ERA) of ultraviolet (UV) filters, the active ingredient used in sunscreens.

Given the evidence that aquatic ecosystems in the U.S. and possibly endangered species are exposed to these UV filters, and given the importance of these ingredients in skin cancer prevention, this assessment is urgently needed and should be shared with the U.S. Food and Drug Administration for consideration in its oversight of UV filters, the report concluded.

UV filters used in sunscreen have been found in numerous aquatic environments, and in water, sediment, and animal tissue. The report focused on the 17 UV filters used in the U.S. Ecological risk assessments compare the concentration at which exposure to a chemical is expected to occur with research on its toxicity, defining the particular settings and conditions under which an environmental stressor might cause ecological impacts. The environmental risk of UV filters is complex, the report noted, because of the variability among filters, environments, filter concentrations, and sensitivity of exposed species.

“An ecological risk assessment will help inform efforts to understand the environmental impacts of UV filters, and potentially clarify a path forward for managing sunscreens,” said Charles Menzie, former executive director of the Society of Environmental Toxicology and Chemistry, principal at Exponent Inc., and chair of the committee that wrote the report. “At the same time, it is clear decision-makers need more information as they navigate protecting both the environment and human health. Federal agencies and industry should fund and pursue research to fill these information gaps.”

An EPA assessment should focus on environments that are more likely to be exposed and that may contain sensitive species, the report said. These could include coral reefs in shallow environments near shorelines with heavy recreational use and limited flow of seawater, or reefs where wastewater and urban runoff enter the water. Slow-moving freshwater systems with heavy swimming and recreational activity or wastewater are another priority for assessment.

Interaction with other environmental stressors, such as climate change, rising ocean temperature, and pollution and other local conditions, should also be considered in an ecological risk assessment. Given the diversity of important species potentially exposed to UV filters, the assessment should include a broader range of species and biological effects than the standard species normally included in toxicity studies.

Because products often contain a mix of multiple UV filters, the ecological risk assessment should examine the impacts of UV filters not just individually, but also when mixed together.

The report also confirmed with a high level of certainty that consistent use of high SPF (30 and above) broad-spectrum sunscreens reduces risk for skin cancer, sunburn, and photoaging. Behavioral studies show that sunscreen use is generally inadequate; sunscreen is not used by all who should use it, too little is used, and it is not reapplied frequently enough.

Reduced availability of sunscreens preferred by consumers may lead to reduced use, which would be expected to have a negative impact on health, the report said. However, changes in sun protection behavior are not easily predicted with current information, and may be dependent on which UV filters are available in a given situation and whether they can provide broad-spectrum protection in a cosmetically appealing product.

The Personal Care Products Council released a statement saying the report “makes clear the environmental and public health data gaps are complex and will require close cooperation among governmental agencies, sunscreen manufacturers and UV filter manufacturers to conduct the needed research. As a science-driven industry, we have been and continue to be committed to advancing robust and reliable research to address these data gaps in both environmental and public health research.

“Our industry’s research aims to develop UV sunscreen environmental monitoring data, a validated standardized toxicity testing model for coral and a multi-tiered ERA model for sunscreen UV filters that realistically reflects what occurs in nature.

“PCPC member companies remain firmly committed to providing consumers with access to a wide variety of safe, effective and innovative sunscreens. Together, we hope sunscreens will remain as much of a public health habit as wearing your seatbelt.”

Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville said the trade group is supportive of the recommendation for stakeholders to work alongside government agencies to generate actionable information for an ecological risk assessment on all currently marketed UV filters.

“Importantly, for consumers, CHPA is also encouraged to see the report reinforce the public health benefits associated with the use of broad-spectrum sunscreen and the importance of formulation flexibility to drive consumer use. As we continue to closely monitor this issue, CHPA remains committed to ensuring consumers have access to safe and effective ingredients that meet their varying preferences for sun protection.”

---

More news and insight into the global nutrition and cosmetic beauty markets …

Mibelle Biochemistry Launches FenuKale Nu Ingredient

Swiss ingredient supplier Mibelle Biochemistry has launched FenuKale Nu, a dietary ingredient formulated to protect the skin from both air pollution and UV rays. The ingredient is suitable for tablets, capsules, beverages, and other applications.

The antioxidant-rich powder contains blue fenugreek and kale extracts to combat the effects of UV rays, ozone, CO2, and particulate matter, which are linked to accelerated skin aging, collagen diminution, skin barrier dysfunction, and chronic inflammation, according to the company. These environmental factors can also have an impact on DNA and change the epigenome.

According to Mibelle Biochemistry, preliminary research on this ingredient provided signs that it may benefit skin health from the undesired effects of air pollution through an interplay of three different mechanisms.

The ingredient may detoxify skin cells from unwanted free radicals, a factor associated with aging. This also reduced the levels of carbonylated proteins in the skin cells, which is a marker for cellular damage.

Further, it was shown the ingredient may reduce the negative impact that air pollution has on the epigenome of skin cells, improving the modification pattern of proteins when treated long-term with urban dust.

Additionally, the ingredient reduced the release of the cytokines IL-8 and CCL-2, potentially leading to a reduced risk of chronic inflammation and improved skin barrier function.

A placebo-controlled human clinical study, which took place in a highly polluted area, found that supplementation improved a number of skin parameters in a pool of participants, according to the company.

After taking 350 mg of FenuKale Nu over a period of 56 days, participants experienced a significant improvement in trans-epidermal water loss, indicating an improvement in skin barrier function. Further, the participants who took FenuKale Nu as opposed to a placebo saw significant improvements in self-reported skin hydration, luminescence, and texture.

---

Topical Black Seed Oil Cream Shown to Improve Skin Appearance

A study published in the SOFW Journal demonstrated that TriNutra‘s B’utyQuin ingredient—a unique breed of Nigella sativa (black seed) oil standardized to 3% thymoquinone—was able to improve multiple characteristics of aging skin, including hydration, elasticity, firmness, and luminosity.

Thymoquinone is a main active in black seed oil recognized for its ability to support balanced inflammatory response, improve mitochondrial activity including ATP production, and deliver excellent antioxidant capacity.

The randomized, placebo-controlled trial was conducted with male and female subjects aged 35-65 with various skin types. Subjects received a standardized topical treatment containing 3% Nigella sativa seed oil (B’utyQuin) and a placebo cream. Study participants applied both products, one on each half of the face, and were assessed at baseline and over the course of the 28-day study using a variety of examinations.

“With a minimum of 3% thymoquinone and very low free fatty acid content, B’utyQuin has shown its ability to impact skin appearance positively,” said Morris Zelkha, CEO of TriNutra. “In addition, B’utyQuin was found to be safe and compatible with all skin types of the study participants. Because of its ability to address skin aging at a cellular level, B’utyQuin can help the body’s natural functions to keep the skin healthy.”

The study determined that the topical application of a cream containing 3% B’utyQuin improved hydration, elasticity, firmness, and luminosity in a statistically significant fashion compared to that of the placebo cream. These results support the mechanisms related to mitochondrial function revitalization expressed in ATP production, linked to efficient energy production, improved respiration, and metabolism of sugars and fat.

Zelkah continued, “additional dermatology research is currently being conducted on B’utyQuin, and we look forward to sharing the results soon.”

Cosmetic applications for B’utyQuin include, but are not limited to, creams, oils, lotions, and serums for the face, body, hair/scalp, oral care, and intimate care.

---

Replenology Hair System Shown to Restore Hair Growth in Women

A 24-week randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the patent-pending Replenology hair system from Arbor Life Labs, which is designed to promote healthy hair growth, prevent hair loss, and activate dormant hair follicles, was published in The Lancet’s EClinicalMedicine journal.

Although scalp hair loss or alopecia is perceived to be a normal sign of aging, it can be a socially debilitating and psychologically distressing condition in women. Losing hair as a woman, especially if young or at a vulnerable time in life, can harm appearance and confidence. Dermatologists agree that there is an unmet need for safe and effective solutions to treat hair loss.

Recent developments in molecular, stem cell, and hair biology have opened a window of opportunity for the development of the Replenology hair system as a natural multi-target solution, the Toronto-based company said.

The trial enrolled 46 women 24-64 years of age with conditions including female patterned hair loss, hair thinning, or diffuse hair loss. Subjects were given a masked treatment regimen of oral capsules, shampoo, conditioner, and follicle serum for daily administration.

The researchers found this Replenology hair system increased total scalp hair density by 33.9 hairs/cm2 and 18.6% more than the placebo. This result is a four-fold improvement in hair growth and response rates in 24 weeks when compared with clinical trials of currently available hair loss products, the company claimed. Researchers also found hair regrowth accelerated during the trial. The publication concluded that a woman may restore her normal hair density with extended use of the Replenology hair system.

“The clinical significance of this trial’s results is a major milestone for the company,” said Peter Feldman, CEO of Arbor and first author of the publication. “Since 1995, scientists have said that there is no single molecule, either orally or topically delivered, that can solve the problem of hair loss. Likewise, it has been stated that there is no single botanical that can target all aspects of hair follicle health. The Replenology formulation, however, is a nutrient combination that supports the requirements of healthy functioning hair follicles.”

The Replenology formulation has been developed to support seven categories of hair follicle health, including growth factors, circulation, anti-androgens, follicle protection, hair stem cell stimulation, immune regulation, and nutrition. Replenology uses active ingredients that have all been well documented in scientific literature as being associated with aspects of healthy hair growth.

As an example, DHT—the most active form of testosterone—is known to disrupt hair cycles and cause hair thinning. Five of Replenology’s ingredients have anti-DHT and other
helpful properties.

“Hair loss can be a life-altering experience for women of all ages,” said Deborah Cahan, executive vice president of Arbor and co-author of the publication. “They’re looking for safe and effective natural solutions that they can trust. The Replenology hair system is clean label, natural, vegan, and free from GMOs.”

Based on a personal journey to find a natural solution to reverse the emotionally devastating effects of dramatic hair loss, Arbor has spent the last 15 years researching and developing multi-molecular targeting approaches to activate stem cells and restore normal physiology to aging tissues and organs. Replenology has been formulated to target 21 molecular pathways associated with healthy hair follicles and works by restoring levels of nutrients that are not normally found in a regular diet and/or hair care products.

---

Gencor Receives Patent for Ageratum Conyzoides Extract

Gencor has obtained a U.S. patent for HairAge Vitae, a single-herb extract for stimulation of hair growth, control of hair loss, dandruff, and certain infections. The patent gives Gencor the rights to use this botanical ingredient, Ageratum conyzoides, in its products. Ageratum, also known as floss flower, is typically a blue flower that can also vary in shades of white, pink, lavender, and red. When extracted and used as a supplement, the flower has clinically-proven mechanisms of helping with hair growth, improving hair health, and preventing hair loss, according to the company.

“We are very pleased to have received the patent on another outstanding product that will help our customers achieve the results they need to prevent hair loss, increase perception of healthy hair, as well as promote healthy hair growth, naturally without harsh chemicals or medicine,” said Gencor’s President Jith Veeravalli. “It is an exciting new addition to our portfolio of life-changing supplements.”