FDA bans sale of most antibacterial soaps
WASHINGTON — The U.S. Food and Drug Administration is targeting 19 ingredients found in soaps and body washes, saying they could do more harm than good.
Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.
This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The agency issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.
Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
Since the FDA’s proposed rulemaking in 2013, manufacturers already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban.
Organic feminine care brand launches at Target
SAN FRANCISCO — Target is teaming up with an organic tampon company to bring women across the country a healthy tampon with modern packaging and accessories to fit any lifestyle.
San Francisco-based brand Cora has launched its premium organic tampon collection in more than 200 Target locations nationwide and online at Target.com. Cora's most popular signature features include: premium organic cotton tampons with BPA-free compact plastic applicators, modern and sophisticated packaging, practical accessories, and a dedication to giving back to girls in need globally with each Cora product sold.
The Cora at Target launch marks the first time that the start-up has been available for in-store retail purchase; previously, Cora was exclusively sold online through a tailored subscription model.
"Target has proven time and again its dedication to partnering with new brands that are trailblazers in their respective industries, particularly when those brands support the movement for healthier and more sustainable products. The Target guest is smart, sophisticated, and savvy. We are thrilled to expand Cora beyond our subscription model as it allows more women in the U.S. to access our high-performing organic period products, while also helping Cora expand its commitment to providing menstrual care to girls and women in need domestically and in developing countries. We won't stop until every woman on the planet has access to the safe and healthy menstrual products she deserves," said Cora Founder Molly Hayward.
Every box of Cora purchased helps provide menstrual products to a girl in need in a developing country.
Procter & Gamble begins stock swap in Coty deal
CINCINNATI — Procter & Gamble announced Thursday its plans for stockholders to exchange its stock for shares in Coty, which has agreed to buy 41 beauty brands from P&G in a deal valued at $12.5 billion.
This represents the next step in the proposed tax-efficient Reverse Morris Trust transaction with Coty Inc. announced on July 9, 2015. In the proposed split-off transaction, P&G will transfer the assets and liabilities of P&G Specialty Beauty Brands, other than specified excluded brands, to Galleria Co., a wholly owned subsidiary of P&G created to facilitate the transaction. Following completion of the exchange offer, Galleria Co. will merge with a wholly owned subsidiary of Coty and become a wholly owned subsidiary of Coty.
The exchange offer announced Thursday provides P&G shareholders with the opportunity to exchange their shares of P&G common stock for shares of Galleria Co. common stock, which will convert into shares of Coty class A common stock upon completion of the merger. The exchange and the merger are expected to be tax-free to participating P&G shareholders for U.S. federal income tax purposes.
The exchange offer includes several key elements:
- P&G is offering to exchange shares of Galleria Co. common stock for shares of P&G common stock that are validly tendered and not properly withdrawn. Procedures regarding how to tender and withdraw shares will be specified in the exchange offer materials distributed to P&G shareholders.
- P&G shareholders have the opportunity to exchange all, some or none of their shares of P&G common stock for shares of Galleria Co. common stock, subject to proration if the exchange offer is oversubscribed. Each share of Galleria Co. common stock will automatically convert into the right to receive one share of Coty class A common stock upon completion of the merger, which is expected to occur as promptly as practicable following completion of the exchange offer.
- Tendering P&G shareholders are expected to receive approximately $1.075 of Galleria Co. common stock for every $1.00 of P&G common stock tendered and accepted in the exchange offer, subject to an upper limit described below.
- P&G expects to issue 409,726,299 shares of Galleria Co. common stock in the exchange offer. The number of shares of P&G common stock that will be accepted in the exchange offer will depend on the final exchange ratio and the number of shares of P&G common stock tendered and not properly withdrawn.
- The exchange offer and withdrawal rights will expire at 12:00 midnight, Eastern Daylight (New York City) Time, on September 29, 2016, unless extended or terminated.
- Galleria Co. common stock will not be delivered to participants in the exchange offer. Participants will instead receive shares of Coty class A common stock in connection with the merger. No trading market currently exists or will ever exist for shares of Galleria Co. common stock.