cosmetics

The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India’s licence to produce cosmetic products at their Mulund plant. FDA’s order will come into effect from June 24.

According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilised by ethylene oxide, a known carcinogenic and irritant.

“While ethylene oxide can be used for sterilisation, the company did not bother to carry out atest after the process to check the amount of residue in the product,” said FDA joint commissioner KB Shende, adding that the company can appeal to the state government before the order comes into effect.

“The products are used for new born babies. It is must for the company to follow all measures,” said Shende adding that the traces of ethylene oxide, if any, should have been measured. The 15 batches in question consisted of 160,000 containers.

When Mumbai Mirror contacted Johnson & Johnson, the company spokesperson confirmed the FDA action. “Nothing is more important to us than the safety of our products and health of the consumers. We continue to manufacture non-cosmetic products at the same site,” the spokesperson said, adding that the matter in question related to a limited number of batches produced in 2007, shelf life of which ended in July 2010.

“The FDA raised concern about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA. This method is widely used for medical devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effect reported concerning any of the batches in question,” he said adding that the company is now in the process of filing an appeal with the state government.

What is Ethylene Oxide?

Ethylene oxide is a known carcinogen. The organic compound is known to be flammable, irritating, anaesthetic and carcinogenic at room temperature.

The USFDA has recommended that companies should measure the residue of ethylene oxide after sterilisation of products and before releasing the products in the market.

Maharashtra’s Food & Drug Administration has cancelled Johnson & Johnson India’s licence to manufacture cosmetics at its facility in Mulund,a suburb in  Mumbai.

FDA’s action is based on a limited number of batches of baby powder produced in 2007, the shelflife of which ended in July 2010. FDA has expressed serious concerns over the ethylene oxide used during sterilisation which aimed to bring down microbial load in the same batch of baby powder produced in 2007.

FDA investigations revealed that before release of these batches, the company did not conduct mandatory test to ensure absence of traces of ethylene oxide which is a carcinogenic substance. Since ethylene oxide was used in the product intended for the use of infants, FDA observed that it was more objectionable.

FDA issued the cancellation order on March 30 this year though it has granted 90 days time (up to June) to J&J to plead its case before the state government if the company desires. FDA’s move comes at a time when the former has already lodged an FIR against one of J&J’s subsidiaries for supply of faulty hip joints.

J&J has two company-owned facilities in India — at Mulund and Baddi in Himachal Pradesh. At Mulund, J&J manufactures J&J Baby Powder, Band-Aid adhesive bandages and Stayfree sanitary napkins. At the Baddi unit, the company manufactures other products. The company also uses third-party manufacturers for production purposes, but the Mulund facility is a large one and also its oldest plant, which was set up in 1959.

Confirming the cancellation, FDA Commissioner Mahesh Zagde said the company had carried out sterilization of 15 batches comprising 1,60,000 retail containers of baby powder deviating from the normal procedure of steam sterilization and adoption of ethylene oxide sterlization.

A J&J spokesman said the company has received the FDA order which pertains to cosmetic products only and the company would continue to manufacture non-cosmetic products at the same site. “The matter in question as cited by the FDA order relates to a limited number of batches produced in 2007. The FDA raised concern about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA. This method is widely used for medical devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effect reported concerning any of the batches in question.”

Further, the spokesman said the company was committed to manufacturing products that meet the high safety and quality standards followed by all global manufacturing sites and meeting all local regulatory standards. “We are working diligently with the agency to resolve this issue,” he added.

(With inputs from Viveat Pinto)

Representative Janice Schakowsky (D-IL), with fifteen co-sponsors, has introduced legislation in the House of Representatives to dramatically increase Food and Drug Administration (FDA) oversight of chemicals in cosmetics and other personal care products.^[1] The Safe Cosmetics and Personal Care Products Act of 2013, H.R. 1385,^[2] includes a number of provisions also included in the Safe Chemicals Act of 2013, S. 696, a bill to modernize the Toxic Substances Control Act (TSCA).^[3] The bill would fundamentally transform the regulation of cosmetics and their ingredients. It expands on prior proposals in a number of respects.^[4] The bill, introduced March 21, 2013, has been referred to the House Committee on Energy and Commerce and to the Committee on Education and the Workforce.

The bill would add a major new subchapter to the Federal Food, Drug, and Cosmetic Act (FFDCA) chapter on cosmetics.^[5] This new subchapter would impose significant new obligations on FDA and on “brand owners,” the entities responsible for bringing a cosmetic to market, whether domestic or foreign establishments. Obligations would also be imposed on ingredient manufacturers and suppliers. The key provisions are as follows:

Labeling

• FDA currently requires cosmetic ingredients to be listed on a label, except that a flavor or fragrance may be listed as such, and trade secret ingredients may be listed as “other ingredients.” Incidental ingredients present at insignificant levels and without technical or functional effect do not have to be listed.^[6]
• The bill would require all ingredients to be listed by name. Contaminants would have to be listed if present at more than 1 part per billion (or lower in some circumstances).
• Like the Safe Chemicals Act of 2013, there would be no trade secret protection for ingredient names. There would be trade secret protection for the concentration of cosmetic ingredients used in a finished cosmetic.
• Nanomaterials would have to be identified as “nano-scale,” using standard of 1% of particles having at least 1 dimension of 100 nanometers or less.
• Vendors of cosmetics sold over the Internet would have to include the ingredient list on their websites.

Safety Standard

• Currently, FDA requires manufacturers to establish the safety of each ingredient and finished cosmetic prior to marketing, and to label any cosmetic whose safety has not been established with a warning.^[7] FDA itself does not routinely review cosmetics or their ingredients for safety.
• Like the Safe Chemicals Act of 2013, the bill would establish a “reasonable certainty of no harm” standard. Under this standard, FDA would have to evaluate whether a cosmetic or an ingredient in a cosmetic would be reasonably certain to cause no harm to members of the general population or any vulnerable population (including pregnant women, children, salon and spa workers, and cosmetic manufacturing plant workers) by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from low-dose exposures (a reference to endocrine effects), additive effects from repeated exposure over time, and cumulative exposures from all sources.^[8]
• The bill would require FDA to ensure that the likely exposure to all sources of the ingredient or cosmetic, including environmental sources, would result in either “not more than a 1 in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval,” or exposure in a concentration “shown to produce no adverse health effects, incorporating a margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources.”

Safety Determinations

• FDA would have to review and evaluate the safety of all cosmetics and ingredients, taking into account information submitted by brand owners as well as “authoritative sources” including the Environmental Protection Agency, the International Agency for Research on Cancer, the National Toxicology Program, the California Environmental Protection Agency, and “any other authoritative international, Federal, and State entity,” as determined by FDA.
• FDA would have to place an ingredient on a list of ingredients that are prohibited or restricted in light of the safety standard, or a list of ingredients that are safe without limits or restrictions (at any concentration), or a list of priority for which additional information is needed. FDA would have to place at least 300 chemicals on one of those lists within 2 years of enactment, and at least 100 per year thereafter. Where needed, FDA would have to specify restrictions on concentration or use necessary for an ingredient to satisfy the safety standard. Manufacturers would have to comply with prohibitions or restrictions within 1 year of listing. Cosmetics containing ingredients on the prohibited list would be considered adulterated.
• For an ingredient on the list of priority chemicals, within 2 years of listing, FDA would have to determine whether the ingredient qualifies for either of the other two lists. If there were to be insufficient information, FDA would have to prescribe minimum data requirements. Brand owners would have to either supply the information or eliminate the ingredient within 18 months of the insufficient information determination. If FDA were to fail to classify a priority chemical as either meeting the safety standard or not meeting the safety standard within 5 years of listing as a priority chemical, the ingredient could not be used in cosmetics.
• FDA would have to annually publish a list of “contaminants of concern” linked to severe acute reactions or long-term adverse health effects.
• Any person could petition FDA for prioritization, listing or delisting of ingredients, or listing of contaminants of concern. FDA would have to respond within 6 months of any “reasonable” petition, as determined by FDA rules.

Reporting

• A brand owner would have to submit to FDA “all data and information that the brand owner can access” regarding the safety of the cosmetic and of its ingredients. The required information would span a wide range of chemical identity, hazard, risk, and use information. The information would have to be updated annually or within 60 days of receiving information on adverse effects suspected to be caused by an ingredient or a cosmetic.
• If a brand owner were to request that a supplier or manufacturer of an ingredient provide any of the information required to be submitted to FDA, the supplier or manufacturer would have to provide it to the brand owner within 90 days of the request.
• A provision would be added for mandatory reporting by brand owners of any serious adverse event associated with the use of a brand owner’s cosmetic, similar to FDA’s current reporting requirements for drugs and medical devices.
• FDA would have to maintain a database of all non-confidential information received under the above requirements.
• Brand owners would have to submit to FDA a cosmetic and ingredient statement providing product use and ingredient information and any warnings and directions for use from the cosmetic label or insert. Failure to submit this statement would render all cosmetics sold by the brand owner misbranded.
• As under the Safe Chemicals Act of 2013, chemical identity could not be claimed confidential business information.

Testing

• FDA would be authorized to require any brand owner to conduct testing to demonstrate that a cosmetic meets the safety standard.
• Suppliers could also be required to conduct testing regarding listed “contaminants of concern.”
• FDA would have to require alternative testing methods where practicable and would have to encourage other means to minimize the use of animal testing of ingredients and cosmetics. FDA would have to publish a list of the alternative testing methods every three years.

Establishment Registration and Cosmetic Listing

• FDA currently encourages voluntary registration of cosmetic manufacturing establishments and filing of finished cosmetic ingredient composition statements.^[9]
• The bill would require annual registration of domestic and foreign establishments manufacturing cosmetics for the U.S. market, along with annual fees. Microbusinesses (those with annual sales from cosmetics of less than $2 million) would be exempt from this requirement. Registration information would include the gross receipts or sales by the establishment from cosmetics, but would not be subject to the Freedom of Information Act. FDA would have to maintain a list of registered establishments.
• Each brand owner would be required to report annually to FDA information about each cosmetic that it markets, including a list of ingredients.

Other Requirements

• New enforcement provisions would be added regarding random annual product sample audits, notification of adulterated or misbranded cosmetics, and orders to recall or cease distribution. FDA could require information about, and from, the supply chain.
• FDA would have to issue guidance prescribing good manufacturing practices for cosmetics and ingredients.^[10]
• An Interagency Council on Cosmetic Safety would be established among FDA, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and EPA.
• There would be no preemption of differing state or local regulations.^[11]
• The bill would also require OSHA to promulgate an occupational safety and health standard regarding material safety data sheets for cosmetics.

Representative Schakowsky has introduced similar bills twice before,^[12] and neither got out of committee, even when the Democrats controlled the House of Representatives. In 2012, with a Republican majority in the House, more moderate cosmetic bills were introduced, but none of them got out of committee either.^[13] Thus, this bill is unlikely to be enacted. However, it does highlight the continued concerns of some legislators regarding chemicals in products and the sufficiency of information available to regulators and the public regarding such chemicals. It also illustrates the embrace by such legislators of ambitious requirements for regulatory programs as a means of dealing with large numbers of chemicals in commerce.

_{[1] Press Release, Reps. Schakowsky, Markey Statement on Introducing the Safe Cosmetics and Personal Care Products Act (Mar. 21, 2013), http://schakowsky.house.gov/index.php?option=com_content&view=article&id=3289.}

_{[2] H.R. 1385, available at http://www.gpo.gov/fdsys/pkg/BILLS-113hr1385ih/pdf/BILLS-113hr1385ih.pdf.}

_{[3] See Beveridge & Diamond, P.C., Safe Chemicals Act, First TSCA Reform Bill of 113th Congress, Reintroduced (Apr. 16, 2013), [link]. The bill also includes provisions similar to those in the Toxic Chemicals Safety Act of 2010, H.R. 5820, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5820ih/pdf/BILLS-111hr5820ih.pdf, the House TSCA modernization bill which Representative Schakowsky co-sponsored.}

_{[4] See Beveridge & Diamond, P.C., Will FDA Get New Authority to Regulate Cosmetics? (July 5, 2012), http://www.bdlaw.com/news-1386.html; Beveridge & Diamond, P.C., Cosmetics Safety Bill Would Incorporate TSCA Bill Provisions (Aug. 2, 2010), http://www.bdlaw.com/news-935.html.}

_{[5] The bill would not alter the FFDCA’s definition of the term “cosmetic” as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” 21 U.S.C. § 321(i). The bill would add a new, broad definition of “ingredient.”}

_{[6] 21 C.F.R. Part 701.}

_{[7] 21 C.F.R. § 740.10.}

_{[8] This standard would go beyond the somewhat similar standards in FDA’s color additive and food additive regulations, 21 C.F.R. §§ 70.3(i), 170.3(i).}

_{[9] 21 C.F.R. Parts 710, 720.}

_{[10] FDA already has such guidance. See FDA, Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (1997, updated 2008), http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.}

_{[11] See Beveridge & Diamond, P.C., States Propose to Regulate Chemicals While Congress Debates TSCA (Feb. 25, 2013),http://www.bdlaw.com/news-1446.html (noting various state proposals to regulate chemicals in cosmetics).}

_{[12] See “Safe Chemicals Act of 2010,” H.R. 5786, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5786ih/pdf/BILLS-111hr5786ih.pdf, and “Safe Chemicals Act of 2011,” H.R. 2359, http://www.gpo.gov/fdsys/pkg/BILLS-112hr2359ih/pdf/BILLS-112hr2359ih.pdf.}

_{[13] See Beveridge & Diamond, P.C., Will FDA Get New Authority to Regulate Cosmetics? (July 5, 2012), http://www.bdlaw.com/news-1386.html.} 

© 2013 Beveridge & Diamond PC

Animal rights group Cruelty Free International says it wants to follow up on the impetus from the complete ban on animal testing in Europe by launching a new campaign targeting the US market.

AkzoNobel claims it has developed an industry leading technology for the eco-friendly extraction of naturally-derived cosmetics ingredients -  a technology that serves to make a significant impact on a product’s carbon footprint.

Los Angeles, CA (PRWEB) March 25, 2013

The Global Cosmetics Manufacturing industry is a dynamic one, characterized by a high degree of innovation and the introduction of new and reformulated products. The past five years have been no exception, despite declining per capita disposable income in key consumer markets. Due to consumers’ tightened purse strings, industry revenue grew only 1.5% in 2009, the midst of the global recession. Profit also suffered as shoppers opted for lower-priced personal care products. The mounting focus on naturally derived toiletries has also underpinned industry performance over the past five years. “Operators have responded to changing consumer preferences for chemical-free cosmetics formulas by introducing and reformulating popular products like shampoos and lotions,” says IBISWorld industry analyst Radia Amari. “Global cosmetics manufacturers are also focusing on natural makeup options, a growing industry segment.” Developing natural makeup products has been difficult because of different challenges like pigment load and ease of application; however, new technologies are emerging that are eliminating some of these challenges.

Demand from emerging economies and aspirational shoppers has also kept the Global Cosmetics Manufacturing industry growing over the past five years, with revenue increases averaging 3.0% per year to reach $243.0 billion by the end of 2013. “Industry operators have consistently expanded their portfolios to cater to underserved markets, where average incomes are well below the average product price,” adds Amari. Moreover, to capture the growing aspirational shopper market (i.e. consumers on a budget seeking designer purchases), firms have integrated high-end cosmetic brands under their umbrellas. IBISWorld expects these efforts, along with improving economic conditions, will drive industry growth during 2013, with revenue increasing 2.4%.

In 2013, IBISWorld estimates that the industry has a moderate level of concentration. Industry concentration has gradually increased over the past five years, in line with acquisitions, whereby large multinational corporations acquire smaller companies. Merger and acquisition (M&A) deals of interest over the past decade that have served to change the face of the industry’s landscape include major player Procter & Gamble’s $57.0 billion takeover of Gillette, L’Oreal’s acquisition of the Body Shop, the purchases of Kanebo and Molton Brown by Japanese-based Kao, and Coty’s acquisition of Unilever’s fragrance division. Other key drivers underlying the ongoing spate of M&A activity include the expansion of geographic footprints, diversification into new product categories or market segments and the exploitation of new technologies, including novel delivery systems and new greener technologies and processes.

As per capita disposable income rebounds more strongly over the five years to 2018, the industry will experience even stronger growth. Armed with deeper pockets, consumers – especially those in developed markets – will be more willing and able to spend on higher-priced products, leading to higher average profit margins for operators. Additionally, players’ efforts to cater to emerging economies will also continue to pay off, further boosting industry growth. For more information, visit IBISWorld’s Global Cosmetics Manufacturing industry report page.

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IBISWorld industry Report Key Topics

This industry prepares, blends, compounds and packages toilet preparations and personal-care products, including perfumes and fragrances, hair care, makeup, oral care, personal hygiene and skin care. Players in this industry are large multinational organizations that operate around the globe. Industry products are predominantly sold in downstream grocery, mass merchandisers and specialty retail stores.

Industry Performance
Executive Summary
Key External Drivers
Current Performance
Industry Outlook
Industry Life Cycle
Products & Markets
Supply Chain
Products & Services
Major Markets
Globalization & Trade
Business Locations
Competitive Landscape
Market Share Concentration
Key Success Factors
Cost Structure Benchmarks
Barriers to Entry
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About IBISWorld Inc.
Recognized as the nation’s most trusted independent source of industry and market research, IBISWorld offers a comprehensive database of unique information and analysis on nearly every US and Global industry. With an extensive online portfolio, valued for its depth and scope, the company equips clients with the insight necessary to make better business decisions. Headquartered in Los Angeles, IBISWorld serves a range of business, professional service and government organizations through more than 10 locations worldwide. For more information, visit http://www.ibisworld.com or call 1-800-330-3772.

GT COSMETICS Manufacturing, the Cebu-based pioneering brand in the beauty industry, has achieved another milestone in its young existence with the launching during the festival month of January of its new product: the GT Carrot Lotion.

The Sinulog Festival, Dinagyang, and Ati-Atihan are perfect occasions to marvel at GT Carrot Lotion’s effectiveness as a sunblock and a moisturizer.

The product, a result of a tedious research process, is something most women want in their lotion as it is a combination of four products rolled into one.

Aside from being a sunblock and a moisturizer, the product is also good for people who want a whitening cream and a body/skin concealer.

In coming up with the product, Engr. Leonora B. Salvane, president and national sales manager of the company, said it is the company’s answer to the continuing clamor of GT product users for new products that are not just affordable but whose quality are comparable with foreign brands.

“It has been through constant clamor of GT product users that pushed me to make this lotion. And finally, this is it!” said Engr. Salvane.

The unveiling of the product coincides with the company’s decision to join for the first time, the annual Sinulog Festival float parade.

Engr. Salvane said the company decided to set aside an amount so it could spruce up a float because she considered the event a venue where she could pay tribute to the Senior Sto. Nino.

“I have to return the glory to God,” she said, as she remembers that it was in the 1990s when she prayed hard as she was in search for a business model that would not only provide her with a good source of livelihood, but would also make her would-be clients satisfied.

Because she considers the company a “miracle” as it was a result of constant devotion to God and hardwork, she named it GT Cosmetics which simply stands as “God-given talent and good things.”

Engr. Salvane prayed for an idea for a new business as she decided to close down her previous endeavor because she could not take anymore the corruption that she had to go through just to sustain it.

Among those who will ride on the float are beauty titlists in several pageants around Cebu and from other parts of the Visayas.

The titlists, all of them self-confessed GT product users, are Keena Soberbino, Pasigarbo Festival Queen 2012; Stefie Aberasturi, Sinulog Festival Queen 2011; Ginafe Jisanan, Bb. Mestiza 2012; Danica Puasa, Ms Consolacion 2012 finalists, models Angelie Kho, Ashley Dragan and Girlie Cabahug.

Also joining are Apriel Smith, Sinulog Festival Queen 2012; Randy Ybanez, Mr. UC 2012; Eugene Ching, Mr. Pintados 2012; Yam Valdego, Mr. Dumaguete 2011; and, Syv Mellivo, Hari ng Negros 2011. (PR)

We asked C&BC packaging veteran Dave Hoenig to scour the aisles of Pack Expo International recently to see what trends he felt were notable. Modularity and new-product launches caught his attention.

When: 11/26/2012 – 11/26/2012

Location: 1 Place des Alpes Geneva, Switzerland

The objective of this 60-minute complimentary webinar is to provide information on how to comply with the new EU regulation for cosmetics products, EC 1123/2009.

Agenda

• Background
• Introduction on EC 1223/2009
• GMP quality approach for Cosmetic Ingredients and finished products
• Introduction to Good Manufacturing Practices for Cosmetic ingredients and finished products
• Certification possibilities for Cosmetic organizations

For more information and to register, visit our Cosmetics GMP webinar

Additional information:
Phone: +41 22 739 91 61
Email: cosmetics@sgs.com
Website: http://bit.ly/SwelOL