Online Exclusives

Safe and Sound

By Christine Esposito, Associate Editor | November 9, 2012

Industry members gather for The Council's annual two-day event that explores ingredient and product safety, microbial issues and more.

Product and ingredient integrity were hot topics at the Personal Care Product Council’s 2012 Science Symposium, which was held Oct. 3-4 at the Marriott Newark Airport Hotel, Newark, NJ.

The opening talk, an hour-long joint meeting of the Quality Assurance Workshop and EFfCi Workshop, was standing room only, as experts covered issues related to Good Manufacturing Practices (GMP) and audit schemes for the safety of ingredients and finished products in the cosmetic industry. The panelists included Steve Greer of Procter & Gamble, Harry Bennett of Rutgers University and Iain Moore of Croda UK who presented “Cosmetic cGMP for suppliers,” “PCMAP (Personal Care Manufacturing Assessment Program) and the role of GMP in the supply chain,” and “EFfCi (European Federation for Cosmetic Ingredients) GMP guidelines for cosmetic ingredients,” respectively.

Quality Assurance Workshop

The Quality Assurance Workshop continued with Karyn M. Campbell, director, Investigations Branch, US Food and Drug Administration’s Philadelphia District Office, who presented an update on FDA’s activities, including an overview of the agency’s reorganization—some of which had just been implemented days before. Campbell then provided information on recent warning letters, including the cyber letter issued to L’Oréal’s Lancôme brand.

“This is called a cyber letter because there is no inspection,” Campbell said, noting that FDA investigators do routine web searches for claims that cross over into the drug area.

Another warning letter presented by Campbell involved a foot scrub. But this went beyond claims issues; the products were adulterated and posed health issues for consumers, the document said.

According to the warning letter, an FDA sample of the foot scrub was found to have excessive microbiological levels. The letter, which was issued in 2012, was written following an inspection conducted in a US facility during which the agency found that the product was prepared, packed and held under unsanitary conditions.

“There are no GMPs for cosmetics,” Campbell told attendees. “When we don’t have GMP regulations established, we always have the Act,” she continued, referring to the Federal Food, Drug, and Cosmetic Act .

In its warning letter, FDA staff said it was compelled to state that the company did not follow GMPs, noted Campbell. Agency inspectors found filth and dust on manufacturing equipment, and said that raw materials were not routinely evaluated from a microbiological safety standpoint and finished products were also not being routinely tested.

According to Campbell, FDA staff was confident that if the foot scrub company challenged the allegations in court, the issues related to GMP would stand.

“We are a very conservative agency, so we felt that these were very egregious,” she said.

A Serious Discussion About B. Cereus

Another hot topic on the docket was Bacillus cereus (b. cereus), which was addressed in the Cosmetic Microbiological Safety session. Dr. Michelle Callegan of the University of Oklahoma presented “Ocular Infections by Bacullus cereus and Other Organisms.”

Dr. Callegan told attendees that B. cereus is ubiquitous in nature.

“You can find it anywhere,” she told the audience, noting that it is even in such mundane places like black pepper.

According to Dr. Callegan the most common forms of B. cereus infection cases are typically gastrointestinal-related however there are non-GI infections—such as wounds or burns, respiratory (pneumonia) and ocular (endophthalmitis).

“Are non-GI B. cereus infections on the increase?” Dr. Callegan asked in her presentation. While only serious infections have been published in the literature and the majority of reported serious cases occurred in neonates, IV drug abusers and immunocompromised patients, a January 2011 alcohol swab recall by The Triad Group has led to increased concern from FDA —including those about B. cereus in cosmetics that are to be used around the eye area.

According to Dr. Callegan, infection with B. cereus usually results in blindness or loss of the eye itself within 24-48 hours, and despite treatment, 60-85% of all Bacillus cereus endophthalmitis cases result in significant vision loss. Also, 48-70% of all bacillus cereus endophthalmitis cases result in enucleation or evisceration of the eye.

Yet, according to Dr. Callegen, there has not been a lot of literature on B. cereus infections in the eye area, and those that have been published involved contact lens wear or eye injuries—such as using a pin to separate eye lashes after application of mascara, for example.

She said that it comes down to personal responsibility with products, and that when a consumer is taught to use them, they need to use that product in that manner. “You can do what you can, put inserts, little fine print—but when it gets to their home, it is out of your control.”

Dr. Callehan told the audience, “I don’t think you need to worry about B. cereus in cosmetics, and that is just my humble opinion.”

The B. cereous conversation continued in the afternoon with Steve Schnittger, vice president of global microbiology at Estée Lauder. His presentation was entitled “Microbiological Risk Assessment Review of B. Cereus.”

While FDA did not consider B. cereus a hazard five years ago, the agency appears to have changed that stance.

“We are here today to further support that B. cereus in our products is not a concern,” Schnittger noted.

In his talk, Schnittger presented a trio of case studies related to bascullus species. His goals were to show how in a preserved cosmetic matrix, these organisms should not be viewed as objectionable, and to focus on the importance of a risk assessment when determining potential risk of a cosmetic product.

The first study involved UK grain workers who were frequently found to be exposed to more than 1 million bacteria and fungi per m3 air. Levels of airborne endotoxin of over 10,000 EU/m3 were recorded and at all but one workplace visited and personal exposures reached over 600 EU/m3 at every workplace. In the study, there were no reported cases of traumatic eye infections even though the bacterial and fungal counts exceeded 1 x 109 c.f.u per gram and long-term exposure to high endotoxin, bacterial and particle levels, did not have an effect on lung function and did not appear to cause chronic lung damage.

The second case involved bacillus cereus in infant formula and came via “Final Assessment Report Bacillus Cereus Limits in Infant Formula Australian – New Zealand Food Standards (FSANZ).” As infant formula can be the sole source of nutrition for infants and frequency of consumption is very high, an infectious dose of b. cereus for infants is of concern because their immune system are not fully developed and are susceptible to bacterial infections.

The New Zealand Risk Assessment Study concluded that levels between 10 cfu – 100 cfu of Bacillus species was not a risk to infants when prepared and stored properly.

The Schnittger presentation also included a Survey of B. Cereus Contamination in Foods:

• 52% of 1546 food ingredients
• 44% of 1911 creams and deserts
• 52% of 431 meat and vegetable products
• Up to 48% of dairy products
• 50% of UHT Milk.

While bacillus species is widespread in food products, according to the presentation by Schnittger, it is estimated that the rate of illness in the USA is 0.1 cases per 10,000,000 per year due to B. cereus.

The final case study presented by Schnittger was bit closer to home as it involvedimported cosmetics. A lipstick or a eye-shadow containing <10 CFU per gram of B. cereus would be delivering 0.01 – 0.05 grams of product per application. It would be delivering 10-2 cfu per gram of a bacteria per application of a preserved anhydrous product—the equivalent to 0.001 cfu per gram of product to an area of the body (the lips), which contains a very high bacterial load.

According to Schnittger, in Case 1 there was a high bacterial load in the eye area with no adverse reactions reported and no long-term adverse reactions observed. In Case 2, it was found to be acceptable that a productwas being given to an immune-compromised population and it contained levels of bacteria that could possibly range from <102 - <105 cfu per gram. And in the third case, there was a preserved or anhydrous hot pour product which is hostile to microbial growth containing levels of <10 cfu per gram of an organism(s) to an area of the body that may contain bacterial levels that could range from 10-1000 times higher than what is being delivered by the product.

In conclusion, Schnittger said data showed that in a non-cosmetic application, B. cereus is not to harmful even at levels 100 times higher than limits used for cosmetic products.

According to Schnittger, industry needs to be persistent with FDA about B. cereus, suggesting that the industry should be willing to take legal steps to defend the safety of its products.

Noting that today’s personal care products today aren’t just “water in oil emulsions being put on hair,” Schnittger said.“Products are more dynamic and the packaging is more dynamic. Risk assessment will help us determine if products are safe, what is the potential risk. And I think that I have shown today that the risks are minimal.”
 
“A company like that one in Ohio should be shut down,” Schnittger added, referring the foot scrub producer cited in earlier discussions. “For those who have processes under control, we don’t need to be told how to test our products. Our processes are in control.”

During the Q&A portion of Schnittger’s presentation, Scott Sutton, a consultant with Microbiology Network (and an earlier speaker at the symposium), supported Schnittger’s stance by telling the audience, “If you are not willing to defend the safety of your products, you get what you get.”
 
 

blog comments powered by Disqus
  • Innovation On Display

    Melissa Meisel, Associate Editor||February 3, 2016
    P&G Beauty Digital Studio showcases new products for 2016

  • Burgeoning Beauty

    Burgeoning Beauty

    Melissa Meisel, Associate Editor||January 4, 2016
    A look at trailblazers for 2016 and beyond.

  • Testing for Sustainable Preservatives

    Adam P. Byrne, William Michael Hart-Cooper, Kaj Johnson, Larry H. Stanker, Dominic W. S. Wong, William J. Orts||January 4, 2016
    A rapid, inexpensive and qualitative protocol for determining microbial growth inhibition.

  • Buy the Sea, Buy the Sea, Buy the Beautiful Sea

    Buy the Sea, Buy the Sea, Buy the Beautiful Sea

    Tom Branna, Editorial Director||February 9, 2016
    Nova Scotia Fisherman makes a boatload of products that contain sea kelp and a raft of natural ingredients.

  • What

    What's on Tap for 2016?

    Nancy Jeffries, Contributing Editor||February 8, 2016
    CEW and NPD present their beauty industry review and preview.

  • Witch

    Witch's Brew: Dickinson's celebrates milestone in 2016

    Christine Esposito, Associate Editor||February 1, 2016
    Dickinson’s celebrates 150 years of witch hazel skin care with the biggest line expansion in the company’s history.

  • From Research to Retail

    Tom Branna, Editorial Director||February 1, 2016
    What began as research on skin disorders led a dermatologist and his father to create their own skin care formulas.

  • 5 Things I Learned

    5 Things I Learned

    January 15, 2016
    The Avon & Women’s Dermatologic Society Mentorship Program. Dr. Sabrina Fabi (left) and Dr. Kimberly Jerdan.

  • Perfect Timing

    Perfect Timing

    Tom Branna, Editorial Director||January 11, 2016
    New ways of collecting data can help cosmetics companies understand what women really want—and when they want it.

  • When a Cosmetic Becomes a Drug

    When a Cosmetic Becomes a Drug

    Jacqueline Sheridan, Dinsmore & Shohl LLP||January 11, 2016
    The unintentional conversion of personal care products through marketing.

  • Africa, Rising

    Africa, Rising

    December 14, 2015
    Savvy marketers should expand their operations on the continent, according to speakers at a WFFC seminar.

  • Color, Your World

    Color, Your World

    December 7, 2015
    A kaleidoscope of concepts was the conversation at a recent NYSCC symposium.

  • A Home of One’s Own

    A Home of One’s Own

    Christine Esposito, Associate Editor||November 23, 2015
    NeoStrata’s Exuviance has opened its first freestanding retail space, complete with on-site skin analysis and express treatment rooms.

  • Hitting a Wall(mart)

    Hitting a Wall(mart)

    November 9, 2015
    Walmart imposes slotting fees and that hurts a lot of Tier 2 and 3 FMCG companies.

  • That’s Quite an Achievement!

    That’s Quite an Achievement!

    Nancy Jeffries, Contributing Editor||November 2, 2015
    The CEW honors seven beauty industry leaders.

  • What

    What's Not to Love?

    Tom Branna, Editorial Director||October 26, 2015
    The sun care category is rife with issues, but there’s a lot to like about it.

  • Sharp Competition

    Sharp Competition

    Christine Esposito, Associate Editor||October 26, 2015
    800Razors.com signs a high-profile athlete to promote its growing direct-to-consumer razor and personal care business.

  • About a Boy

    About a Boy

    Christine Esposito, Associate Editor||October 19, 2015
    As a mom, Jenny Cupido wanted to solve her son’s skin issues. Now she’s raising an indie beauty brand too.

  • A Suite Deal

    A Suite Deal

    October 12, 2015
    Image Studios provides an innovative venue for beauty professionals seeking a new way to do business.

  • For Their Own Good

    For Their Own Good

    Christine Esposito, Associate Editor||September 29, 2015
    With a rich heritage and recognized formulation expertise, FC Sturtevant Company is moving into the consumer marketplace.

  • A Foothold in Foot Care

    A Foothold in Foot Care

    Christine Esposito, Associate Editor||September 22, 2015
    Treating feet right is the heart and soul of one Brooklyn-based company.

  • SK-II to the Rescue

    SK-II to the Rescue

    September 8, 2015
    A new formula targets microRNA, which a P&G researcher insists plays a key role in skin aging.

  • A Panoramic View

    A Panoramic View

    Jeremy Kerstetter, Assistant Editor||September 7, 2015
    ZSS takes a 360° approach to skin health.

  • It

    It's All in the Delivery

    Jeremy Kerstetter, Associate Editor||August 31, 2015
    AlureVé relies on pharmaceutical technology for its anti-aging skin care line.

  • A Brand of Its Own

    A Brand of Its Own

    Christine Esposito, Associate Editor||August 24, 2015
    Amyris creates its own skin care solution for consumers.

  • Eye on Korea

    Eye on Korea

    August 17, 2015
    At the Personal Care Conference in Shanghai there was distinct emphasis on beauty ideas from Korea.

  • No Coasting Here

    No Coasting Here

    August 12, 2015
    A Q&A with Coast Southwest CEO Joseph Cimo.

  • Game Face

    Game Face

    Christine Esposito, Associate Editor||August 3, 2015
    Meet the team behind Sweat Cosmetics, a new line of makeup built for more than a walk in the park.