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OTC Drug Monographs and Cosmetics Part 2

Monographs specify the active ingredients, levels of actives and permitted combinations of active ingredients that can be used in cosmetics that make OTC drug claims. Monographs also contain guidance on labeling and test methods to verify efficacy.

Components of the Drug Facts Label

  • Active Ingredient(s) – Active ingredients and the percentage of each in the product are listed. Generally these are weight percent but there are exceptions. For example the Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products used % volume.
  • Uses – Symptoms or disorders that the OTC drug is indicated for.
  • Warnings – When the product should not be used, what at physician or pharmacist should be consulted, factors that may alter the expected response to the product, and common side effects.
  • Directions – Dosage and frequency of use. Can be sub-dived by age group, size, or other factors that may affect response to the product.
  • Other information – Special instructions as needed. For example, storage conditions to preserve the shelf life of the product.
  • Inactive Ingredients – The ingredients that comprise the delivery vehicle of the product.

Test Methods

The appropriate test method is designated in each monograph along with details regarding laboratory validation, instrument calibration and standard materials to test against when appropriate. The final product must pass the test as described by the monograph to claim efficacy.

While monographs are lengthy and complicated, they exist to protect consumers. That’s why it is important to have a deep understanding of the monograph when working on formulating cosmetics that are also OTC drugs.

Click this link to see part one of over the counter drugs and cosmetics.

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We’ve looked at the definitions of cosmetics, drugs, and cosmetic drugsFDA-monographs in the past, and listed cosmetics that have FDA monographs.  So, we thought we’d give more background on monographs and what they mean for cosmetic formulators.

Historical background

Before the Federal Drug Administration (FDA) existed most drugs were available without prescription. Unscrupulous individuals could bottle anything and sell it as a miracle cure. In 1938 the Food, Drug, and Cosmetic (FD&C) Act gave the FDA authority to issue regulations and was amended to clarify the difference between over-the-counter (OTC) and prescription drugs. OTC drugs are thought to be generally safe and effective (GRAS) and can be sold without prescription.

The Monograph Process

The monograph process has three phases each requiring publication in the Federal Registrar (FR), the official publication of the United States government which contains t contains government agency rules, proposed rules, and public notices. The first phase is a review by advisory panels. The panels determine whether or not fit GRAS criteria and are safe for self-use. The panel also reviews claims and recommends labeling. The findings of the panel are published in the Federal Registrar as an advanced notice of rule making (ANPR) which is followed by a period of time is allotted for public comment.

The panel classifies ingredients into three categories:

Category I – Generally safe and effective for claimed therapeutic indication

Category II – Not generally recognized as safe and effective or unacceptable indications

Category III – Insufficient data to permit final classification

Phase two is an assessment by the FDA including the panel review from phase one along with public comments and inclusion of any new data that has become available. The agency then publishes its conclusions in the FR as a tentative final monograph (TFM). Again, there is a period of time set aside for additional comments and data to be submitted from the public.

The final phase is publication of the monograph. After the monograph is published, products containing active ingredients not included in the monograph require a new drug application or a time and extent application which requires that the ingredient have demonstrated safe use in markets outside the US for at least 5 years. While monographs can be updated, it’s often a very long process. There are currently 8 ingredients that have been waiting for approval for the sunscreen monograph, some since 2002.

In part 2 we will look at the parts of an OTC monograph.

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Market Research Basics for Cosmetic Chemists

In any big company there will be a group known as Marketing Research which every cosmetic formulator will have to interact with eventually. In this post, we’ll go through the most basic information about what the group tries to accomplish, how it will effect you and how you can use them to become a better cosmetic chemist.

What is Market Research

If you spent all your time in science classes you may never have had the chance to learn about market research. Essentially, it is the process by which companies find out useful information about their consumers, potential customers, and the marketplace. It is done using standard questionnaires, home use tests, or moderated focus groups.

Focus group — During the early phases of a new project, the market research group will organize focus groups of expected customers. These are round table discussions where a moderator talks to the customers and finds out what they think. In the meantime, you, your marketing group, and anyone else from the company who might be interested sit behind a two-way mirror, observing and taking notes about what is being said. Ideally, you’ll get a good sense about what people like, don’t like, and want.

Often these groups are convened after the consumer has tried one of your prototypes so this discussion can help you see exactly what is working and not. Focus groups can be extremely useful for finding new product ideas and helpful for figuring out what is good and bad about your formula. However, they can also be misleading as they represent only a small fraction of your customer base. Don’t put too much stock in the impressions you get from focus groups.

Home use test — These are formal tests where you create prototypes, send them home with consumers, and get feedback after they have used them for a few weeks. Home use tests can give you an excellent idea about how your new formula stacks up against competition or previous prototypes. Of all the types of market research you might encounter, home use tests are the most useful to cosmetic chemists.

But be cautious when analyzing the data generated from home use tests. The more detailed the question, the less accurate the answers. People often do not know why they like a formula or not and they are easily swayed by the halo effect. The most significant question asked in a home use test is whether or not the consumer liked the product. All other detailed questions should be taken less serious. For example, if your home use test demonstrates that your product doesn’t foam enough, be sure to see whether they liked the fragrance. Often if people don’t like the fragrance, they find other things wrong. It’s also important to run a control when doing a home use test but unfortunately, this costs extra money that companies don’t always want to spend.

Why use market research?

There are a wide variety of reasons that a cosmetic chemist would want to use market research. Here are just a few examples.

1. To figure out what your customers want — When you are trying to come up with a new product idea, asking consumers what they want is often a good strategy. Of course, consumers don’t really know what they want so you have to ask the right questions to get good ideas. The best things to focus on are the problems that consumers are experiencing. Once you know the problem, then you can come up with a solution that people might want.

2. To figure out what customers like — Market research is a great way to learn what people like. When you are formulating, you’ll generally create products that you like using. This is fine but you should remember that you are not making products for yourself. You are making them for consumers. Once you get a product you like, ask consumers whether they like it too. If they don’t, change it.

3. To make yourself feel better about a launch — Research studies are often done so late in the process that the information they provide can’t be used to modify the formula. This is an unfortunate reality. On the plus side, if your formula does well on the home use test, you can feel confident that your boss, their boss, and your marketing group will feel happy. And if the product doesn’t happen to be successful in the marketplace, no one will blame the formula.

4. To find potential problems — One of the best things about giving consumers your product to try before it gets launched is that you’ll quickly find any potential problems that you didn’t notice. Perhaps, there is an off-odor in the fragrance you didn’t detect or the packaging is too difficult to open. Consumer studies are great for finding problems like these.

What are the limitations?

While it is known as ‘market research’ the quality of the research is not the same as scientific research. The biggest problem with this type of research is that it is incredibly subjective and there is a wide range of variability. In fact, I’ve personally done tests where we tested the exact same formula among two different groups of 100 consumers and got opposite results. If you can’t reproduce a result, the conclusions from the result can’t be relied upon.

However, your market research group (and the rest of your company) will not likely see it from a scientific minded view. They will look at data obtained from market research as equivalent to that obtained from laboratory instruments. It’s not, of course, but you will have a hard time changing their mind. Just glean what you can from the data, ignore things that don’t make sense, and never rely on specific market research data to make drastic changes to your formulas.

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Allured has a new book out about Sustainable Cosmetic Product Development. If you are interested in formulating for the Natural, Organic or Green market, this is an extremely useful book.

Cosmetic book summary

The first chapter looks at the development of the Green market and gives a great overview of the history of how the market has evolved. The second chapter is a bit more useful for formulators as it goes through the worldwide standards for Green, Natural and Organic products. This gives you great direction on how to formulate for specific places in the world. The next chapter gives an excellent overview of what it means to formulate with green ingredients. The next four chapters are probably the most useful ones in the book. They go through exactly how a formulator can use green principles to create hair products, skin products, color cosmetics, and fragrances. The final three chapters are related more to the work that goes on after formulating including one on green packaging, global sourcing of ingredients, and a final chapter on the environmental impact of cosmetics.

Book review

If you are asked by your marketing folks to make your formulas more “natural” or “green”, this book is an excellent resource. It gives you a solid background of the different definitions of green cosmetics and talks about all the certification programs around the world. Then it tells you exactly which ingredients can be used as substitutes for traditional, synthetic compounds. This compilation of ingredients with specific applications is a great resource. My only complaints about the book is that there was a little too much focus on history in the hair chapter and the Index could be more thorough.

Final comments

Overall, if you are going to be doing any natural formulating (and almost every cosmetic chemist will) this book is an invaluable resource.

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Careers in Cosmetic Science

There are many opportunities for careers in the cosmetic industry. Graduates with a background in various science disciplines have skills and expertise that are marketable in many areas of the industry. The cosmetics industry can be divided into five basic categories:

  • - Finished goods manufacturers
  • - Raw Material Suppliers
  • - Consultants and Testing
  • - Laboratories
  • - Government
  • - Academia

Further more, job descriptions in the cosmetic industry are numerous and varied including:

  • - Product Development Chemist/ Cosmetic Chemist
  • - Analytical Chemistry for raw materials and production
  • - Cosmetology
  • - Manufacturing Engineer
  • - Safety Specialist evaluates raw materials and finished goods to establish their safety during use
  • - Regulatory Specialist ensures compliance with local and global regulations
  • - Toxicologist/Safety Specialist evaluates raw materials and finished goods to establish their safety during use
  • - Microbiologist
  • - Packaging Engineer
  • - Perfumer
  • - Claims development to support product performance
  • - Perfumer
  • - Quality Assurance
  • - Technical Sales Representative assists customers (product developers) with formulation and technical support
  • - Marketing
  • - Science Public Relations
  • - Educator

So you can see there are a wide range of career possibilities depending on what you find most interesting.  If you’d like me to elaborate further on any of these roles in the cosmetic industry, leave a comment below and I’d be happy to do a more in-depth discussion.

For some of the best cosmetic science tweeting around, follow Kelly on Twitter.

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Here’s an interesting trend that will affect cosmetic chemists and formulators in the future. More and more, natural ingredients are replacing standard cosmetic raw materials. What will this mean?

Cosmetic reformulation

Cosmetic chemists will no doubt have to reformulate almost all the products that they have. Anything that contains a petroleum derivative will have to be re-worked to contain only plant and sustainable ingredients. This might seem like a lot of trouble but it is good news for formulators because it gives you some new opportunities to create new formulations.

One of the most frustrating aspects of being a cosmetic chemist is that you make very few changes to formulas. In truth, a company doesn’t want to stray too far from their existing formulations because using new raw materials requires more warehouse storage, raw material ingredient costs will increase because you are not buying in bulk as much and the stability and performance is less well known.

There are forces that work against creating truly new and innovative formulations.

Good for raw material suppliers

Raw material suppliers will also like this trend because they can more easily get chemists to start using new raw materials. One of the biggest challenges raw material suppliers face is that chemists do not like to use new raw materials. The reason is that they are unproven and almost always more expensive. Now, raw material companies will be able to sell new raw materials that are more profitable.
On the other hand, there are some problems with this new trend.

Not all positive

The biggest problem is that substitution of raw materials with new ones will not likely lead to improved products. In fact, it will probably lead to products that don’t work as well. It used to be that a cosmetic chemist would switch out a raw material for some performance reason. They discover that some raw material works better than their current so they make the switch. But with this trend, cosmetic chemists are switching out raw materials for a non-performance based reason. Naturally, performance will likely suffer.

But perhaps the worst aspect of this trend is that consumers will have to pay more money for formulations that do not work as well. They are the losers in this trend.

Although, one could argue that consumers are not paying enough for their cosmetics right now. They are not covering the cost that cosmetic use has on the environment and they should. So, perhaps the fact that consumers pay more for better sustainable products is overall a good thing. I’m just not sure consumers will agree with it.

Do you?

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Glycation and skin aging

Glycation, also referred to as non-enzymatic glycosylation, is the chemical reaction of aldehydic groups of reducing sugars with free amino acid groups of proteins. Collagen, elastin, and fibronectin, the structural proteins of the skin, are all susceptible to glycation. The advanced glycation end products (AGEs) produced by this process result in changes to the mechanical properties of skin, discoloration, and loss of radiance.

cosmetic glycation

 

Most of what we know regarding glycation is the result of research about diabetics, where prolonged high levels of blood sugar can lead to debilitating conditions.

While glycation is part of the natural aging process, it can be sped up by diet, inflammatory events, and UV exposure. Some AGE’s fluoresce allowing for the assessment of glycation using instruments like the Visia Complexion Analysis system from Canfield Scientific.

Glycation Anti-Aging Strategy

While there are many mechanisms involved in skin aging, slowing or reversing glycation presents an interesting approach to anti-aging treatments. Diabetes research and treatments may yield new insights and generate innovative ideas for cosmetic formulation.

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The hardest things a cosmetic chemist has to do

There are some aspects of cosmetic chemistry that are easy but there are others that can be a but difficult. This list refers to the latter.

1. Generating new product ideas. There’s a reason that cosmetics haven’t changed much in the last 30 years. It’s very difficult to come up with something new and original. The cosmetic chemist who can do this will be in excellent shape to advance her career. Try some of the innovation exercises that we suggest.

2. Solving stability problems. Sometimes it’s not obvious why a formula isn’t stable. When this happens it’s tough to fix. But a knockout experiment can be very helpful.

3. Politicking. In a corporation your success is highly dependent on your ability to interact with other people. Your knowledge of science is just not as important, unfortunately. Learn some interpersonal skills to get better at this aspect of your career.

Cosmetic chemistry is not necessarily a difficult career but there are certainly some challenges. If you can excel at the hardest things you will be well on your way to a successful cosmetic chemist career.

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There is a popular Internet meme called Throwback Thursday where people are encouraged to post something interesting about their past (usually a picture).  We’re going to try it here on Chemists Corner.  Today Kelly looks at a cosmetic ingredient that was much more widely used in the past.

Squalane

Squalane was a commonly used and very effective emollient with excellent skin feel. It is a hydrocarbon with a 24-carbon backbone and 6 methyl group side chains spread across the molecule as seen in the diagram.

squalane cosmetics

Squalane

It has fallen out of favor in recent years due to unfavorable sourcing (animal derived, from shark liver oil) plus the instability of supply and cost from olive-derived squalane. But squalane may be poised for a come back due to innovative fermentation methods that produce sqaulane from sugacane.

Squalene

Squalane is similar to squalene which is a lipid and naturally occurring component of human sebum. It has a 24-carbon backbone and 6 methyl group side chains but is unsaturated containing 6 double bonds along the backbone.

squalene

Squalene

It is also found in some plants and the liver of deep sea sharks. The presence of double bonds leads to oxidative stability problems with sqaulene. That lead to the hydrogenation of squalene to create sqaulane.

Squalane resurgence

Sqaulane has good sensorial properties and is effective in reducing transepidermal water loss.

As mentioned previously, sourcing from sharks and cost concerns of olive-derived squalane dramatically decreased usage. Recently, the use of fermentation to create a bio-synthetic precursor to sqaulene has made the production of a more consistent and cost effective sqaulane possible. Will sqaulane make a comeback in the cosmetic industry? A quick search of Sephora.com shows there already appear to be a few new products containing squalane on the market. Will your formulation be next?

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Cosmetic Chemist Jobs – Where to find them

Here on Chemists Corner we get a number of requests from people who are looking for jobs.  In fact, we’ve written a number of articles about this which you can read about on our cosmetic chemist careers page. cosmetic formulating job

But these articles are more general and it seems there is a need for more specificity telling you exactly where to apply for a job.  Of course there are a number of online sources which you can scour through.  Here are 5 cosmetic job sources.

Society of Cosmetic Chemist job posts

One source which you may not be aware of is the job pages on the various SCC chapter websites.  In know the Midwest SCC has listings because I’m the one who usually posts them.  So, to make it easy for you I’m going to list all of the chapter job pages here and you can click on whichever one is in an area where you are interested to work.  I should mention that sometimes the jobs listed on a chapter page refer to jobs elsewhere in the country so if you’re looking, be sure to go through all the chapter pages.

Here they are.  Good luck!

California Chapter
Carolina Chapter
Connecticut Chapter
Florida Chapter
Intermountain West Chapter
Lake Erie Chapter
Long Island Chapter
Michigan Chapter
Mid-Atlantic Chapter
Midwest Chapter
New England Chapter
New York Chapter
Ohio Valley Chapter
Ontario Chapter
Quebec Chapter
Southeast Chapter
Southwest Chapter
St. Louis Chapter
Twin Cities Chapter

If you know of any job opportunity sources that we missed be sure to list them in the comments below.

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