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United States Office:
International Cosmetics & Regulatory Specialists, LLC
European/United Kingdom Office:
International Cosmetics & Chemical Services, Ltd
Regulatory Services for the Cosmetic and Chemical Industries
US: +1 310 545.3223
EU: +353 1 2343750 EX. 1512
UK: +44 (0)1753.680980

Clean beauty is creating quite a buzz right now. Many companies and brands are pushing for clean beauty products, but there is no legal or official definition of what clean beauty is. Because there is no official definition, brands are claiming “clean beauty” standards that align with their own agendas. The industry consensus is that clean refers to products that favor natural ingredients, but still include synthetic ingredients that have been deemed safe for people and the planet. These clean brands typically avoid ingredients or chemicals that can be irritants or allergens. Some brands define clean beauty as “natural” or “organic”, however, those buzzwords are not a requirement to be considered clean, and those claims can trigger other requirements. The FDA (U.S. Food and Drug Administration) does require companies have the ability to prove that their products are safe.

The European Union and the United States regulate their chemicals differently. For a US brand to market in the EU, it would have to adhere to the EU standards and vice versa. While each standard has a different approach, both the US and the EU have the same goal: to assure that products are safe for the consumer. 

If you are considering creating a clean beauty brand, remember that your product must be safe and have clear and transparent labeling. Labeling should be appropriate for all places that your products are marketed, as all countries, and even some individual states in the US have different requirements. All claims must be truthful and be able to be proven, as required by the Federal Trade Commission (FTC) in the US, and similar agencies overseas.  Also, while it is a good idea to be mindful of the ingredients in your products, it is important to monitor changes as the science continues to evolve. The cosmetics industry is continually innovating, and scientific studies continue to be done to assure that any and all changes within the industry continue its enviable track record in developing safe products.

Check back with us for more information on clean beauty, the Safe Cosmetics Act, CA Prop 65 and more! 

               Several studies around the globe have been conducted to test the efficacy of mouthwash as a way to reduce the spread of COVID-19. Some of these studies have been conducted by the American Physiological Society, Ruhr-Universität Bochum, and the Tropical Infectious Disease Research and Education Center (TIDREC) at the University of Malaya in Malaysia.

               In Malaysia, TIDREC confirmed the effectiveness of BETADINE Gargle and Mouthwash against SARS-CoV-2, which causes COVID-19. The study included testing BETADINE in two concentrations, undiluted and at a 1:2 dilution. In both cases, the testing demonstrated a strong in-vitro virucidal activity, with the tested products killing 99.99% of the virus in 15 seconds.

               In Germany, at the Ruhr-Universität Bochum, researchers tested 8 different mouthwashes with different ingredients. In their study, researchers mixed each mouthwash with virus particles and an interfering substance (to mimic saliva) and was shaken for 30 seconds to simulate gargling. All the tested preparations reduced the initial virus concentration (titer). 3 of the mouthwashes tested eliminated all trace of the virus. 

               The American Physiological Society published a study in a new journal, called Function, that looked at the viral lipid membrane disruption by widely available dental mouthwash components. The researchers say that the virus is highly sensitive to agents that disrupt lipid bio-membranes. They also write that the lipid envelope does not vary when a virus mutates, so if the strategy of using mouthwash to reduce the spread of COVID-19 is found to be effective, it should still work against the new strains that may emerge.

               It is important to remember that all of the results from these various studies show that mouthwash can be used in the short-term to help prevent the spread of the virus, but other preventative measures are still necessary. The use of PPE and washing your hands regularly are still considered to be the most effective way to prevent the spread of the virus. All the researchers are doing more work to determine if mouthwash can have any long-term applications regarding the SARS-CoV-2 virus.

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As COVID-19 rages on, many people in the cosmetic industry are worried about how their companies will fare. Many companies that produce cosmetic and topical over-the-counter drug necessities, such as shampoo, toothpaste and deodorant are expected to maintain their usual level of sales. Of course, hand soaps and hand sanitizers have seen a boom in sales. Consumer demand is lower in a few categories for the short term, but are expected to bounce back quickly, with items including skin care and hair care. Many consumers are looking for products that will assist them in relaxing and self-care practices. In fact, consumers are more engaged in the beauty industry than ever before. It’s the products they are purchasing that is shifting.

Technovio, a market research company, predicts that men’s skincare products market will grow by $1 billion USD between 2020 and 2024. Anti-pollution and multifunctional skincare products are expected to be the driving factors in the market growth.

Among younger generations, lip balm and lipstick are considered the most essential cosmetic product to purchase, followed by mascara and concealer, a study by Rising Consumers Market Research shows.

Although the world is going through an unprecedented pandemic and recession, “the beauty market is fairly recession-proof, and its products will continue to be desired by consumers—both for meeting basic needs as well as an indulgence”. Our company can help yours by ensuring your products stay on the market because they meet all the federal requirements. We can assist with labeling compliance, FDA registration, Good Manufacturing Practices, European Union product requirements, and much more. 

The Personal Care Products Council (PCPC) and the President of the American Academy of Dermatology respond to claims made in the Wall Street Journal article “Sunscreen Chemicals Accumulate in Body at High Levels”. The article, published July 17, 2020 by Jo Craven McGinty, states that the six chemicals, studied by the FDA, “absorbed into the bloodstream at concentrations far greater than the Food and Drug Administration’s safety threshold” which is 0.5 nanograms per milliliter. The author also compares the absorption of the sunscreen chemical concentrations, which ranged from 3.3 nanograms per milliliter to 258.1 nanograms per milliliter, to the concentration level of THC, the marijuana compound that gets a person high. The comparison stated that 4.0 nanograms of THC corresponds to a blood alcohol content of 0.04%, the equivalent of two beers for a person that weighs 180 pounds. PCPC responded on July 23, 2020 stating that the article is “misleading and unnecessarily alarming about the safety of sunscreen products on the market today”. In the response, PCPC explains that the 0.5 nanograms per milliliter threshold is set by the FDA to determine if additional testing is required to meet Generally Recognized As Safe (GRAS) standards. The most important thing to note is that the standard does not state that anything higher than 0.5 nanograms per milliliter represents unsafe levels. Additionally, PCPC recognizes that the comparison of the levels of the sunscreen chemicals to the levels of THC needlessly scared consumers and entirely inappropriate. Sunscreen is neither a controlled substance nor an alcoholic beverage and the comparison of the three is ridiculous. On July 27, 2020 Bruce H. Thiers M.D., President of the American Academy of Dermatology wrote a piece for the Wall Street Journal stating that “unprotected exposure to the sun’s dangerous ultraviolet rays is the most preventable risk factor for skin cancer” and that “sunscreen can help protect the public from harmful ultraviolet rays”. Cancer, and not chemicals found in sunscreen, is the biggest threat to people.

2020 has been a year that will go down in the books. We have experienced shortages of toilet paper, cleaning products and hand sanitizer. With these various shortages, manufacturers have been working especially hard to restock the shelves of our supermarkets and big box stores. This is nice and easy for the companies that were already manufacturing the products, but especially with hand sanitizer, many companies that traditionally made other products turned their focus to creating these out of stock products. Many alcohol distilleries have made the decision to produce hand sanitizer, among other companies. Because of non-industry companies wanting to help, the FDA created a Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (FDA). With these guidelines, and the World Health Organization’s easily available “Guide to Local Production: WHO-recommended Handrub Formulations” it is easier than ever for these companies to create approved hand sanitizer.

Unfortunately, some companies are taking advantage of the shortage and are using unapproved ingredients in their formulations that have major health consequences for the consumers. According to a press release from the FDA, they “have seen an increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but have tested positive for methanol contamination.” Methanol is a wood alcohol that is often used to create fuel and antifreeze. It can be toxic when absorbed through the skin as well as life-threatening when ingested. The FDA warns that methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. The people most at risk are children who accidentally ingest products containing methanol, and adults who drink hand sanitizer as an alcohol (ethanol) substitute. The CDC has reported several adverse health events associated with these methanol-based hand sanitizers, including at least four deaths from ingestion. A concern with this is how can the consumer tell that their product has methanol? The FDA has a list of over 100 brands that have been tested and were positive for methanol. Check out that list here. If you feel any of the effects listed above, make sure to report it to the FDA with as much information as possible here

If your company is interested in producing hand sanitizer, check out our hand sanitizer tab! We can help you get the correct license for hand sanitizer production!

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When you think of a cosmetic, do you think of your shampoo? How about your deodorant? Now, when you think of an over-the-counter drug, do you think of your fluoride toothpaste? How about your moisturizer with SPF? You may be surprised by what is considered a cosmetic and what is considered an over the counter drug by the FDA.

According to the FDA, a cosmetic is defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance”. It defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease… and articles (other than food) intended to affect the structure or any function of the body of man or other animals” (FDA).

Some commonly known cosmetics are eyeshadows, lipsticks, foundations, etc. Some cosmetics you may not have known were cosmetics include tattoo ink, henna, toothpastes (that do not include fluoride), and skin moisturizers (without SPF).

Some over-the-counter drugs that everyone knows about include aspirin, cold medicines, and cough drops. You might be surprised to learn that hand sanitizer, acne cleansers, and petroleum jelly are considered drugs by the FDA as well.

It is important to remember that this is according to the US definitions of cosmetics and over-the-counter drugs, and there are different regulations in other parts of the world. For example, in the EU sunscreen is a cosmetic, rather than an over-the-counter drug as defined by the FDA.

We are able to assist you in determining whether your product qualifies as a cosmetic or over-the-counter drug in the US and abroad, and then receiving the proper certifications for them as well! Check out our services page for a comprehensive list of all our services.

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Sunscreen is considered a summertime essential. As summer starts to hit its peak in the US, we want to discuss some fun facts about sunscreen. Did you know that it has been in existence since the 1940s, but sunscreen has only been regulated by the FDA since 1978 in the US (NBCNews)?

               Sunscreens are regulated as an over-the-counter drug in the US because they claim the prevention of sunburns, and if they are a broad-spectrum product, they also claim the prevention of skin cancer and early skin aging. In the EU, sunscreen is considered cosmetic, so it is regulated as such. However, the UV filters in sunscreen must receive pre-market approval in the EU (PCPC). As an FDA-regulated product, sunscreens must pass various tests before they can be sold in the US.

               Most people in the US and EU have been applying sunscreen for years, and yet somehow, many of us still get burned somewhere! Did you miss applying your sunscreen to one of these commonly forgotten areas? The ears, nose, lips, back of neck, hands, top of feet, and along the hairline and exposed areas of the head are most missed. Double check that you have applied your SPF on these areas and don’t forget to reapply! There is no such thing as waterproof sunscreen, so remember to take a look at the label on your package. Should you be reapplying your sunscreen every 40 or every 80 minutes while you are playing in the water or sweating? FDA requires this information on the label, so it should be there. Of course, at a minimum, you should be reapplying every 2 hours when you are lounging, so grab someone to help lather you up!

               While you are out enjoying your time in the sun, remember that your sunscreen has active ingredients, so it should not be left out in direct sunlight! You can wrap your sunscreen up in a towel if you’re at the beach, keep it in your backpack while you’re hiking, and even throw it in your cooler to add a refreshing factor on a hot day. Whatever you do, make sure you have plenty of sunscreen with you to protect yourself from those UVA and UVB rays.

               Let’s talk a little bit about those pesky UV rays. Your sun protection factor (SPF) value tells you how much sunburn protection is provided by your sunscreen. SPF value ONLY indicates your sunscreen’s UVB protection. UVB rays are the rays that cause sunburns, and UVA rays can cause skin cancer and skin aging. That is why it is important to look for sunscreens that are broad spectrum because they protect from both UVA and UVB rays. Remember to use at least SPF 15 to get the most protection out of your sunscreen!

               We hope that you enjoy your summer as much as you can and stay safe!Hawaii 2Hawaii 2

The FDA has issued a fresh warning to consumers about the risks of having a tattoo.

The regulator has launched the ‘think before you ink’ campaign to highlight the risk of potential infections from contaminated ink and bad reactions to the ink itself.

According to the federal agency, 363 reports were made regarding adverse events from tattoos 2004-2016

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