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‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation

ICMAD leadership agrees with Bailey that, now more than ever before, the pieces are in place for cosmetics reform legislation to reach the finish line. At the same time, the small-business advocate remains opposed to leading proposals, signaling the significant distance that negotiations may still have to go.

Legislation Consumer United States

Estee Lauder Is Revising Claims, Retesting Products After Internal Breakdown

Lauder says “a small group of employees” is responsible for intentionally altering testing behind product claims, misconduct alerted to management through the firm’s internal escalation process. Currently, the scope of the issue – and the potential impact on Lauder’s business – is unclear, but claims revisions of varying magnitude are expected as the company’s review progresses.

Advertising, Marketing & Sales Business Strategies Market Intelligence

Gingko Supplement Adulteration Points To Broader Problem For FDA – CSPI

Nutrition and food safety watchdog group asks FDA to enforce against marketers of ginkgo supplements after ConsumerLab.com found that six of 10 ginkgo supplements it tested contained either less of the herb than advertised or different and cheaper plant material.

Dietary Supplements Safety Manufacturing

SPF Fraud Cases Hard To Shake, Could Shine Light On FDA Protocol Problems

As SPF defendants’ dismissal motions continue to be shot down in federal courts, it increasingly seems that their SPF claims and the radically different test results alleged by plaintiffs will have to be subjected to rigorous analysis and expert opinion, undertakings that could shine light on inherent problems with FDA’s testing protocol rather than overt moves by companies to inflate the protective capacity of their products.

Legal Issues Consumer United States
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Regulation Explore this Topic

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Supplement Firms Making Sunscreen Claims Warned In FDA Crackdown

Claims that rendered the firms' products unapproved new drugs and were listed in FDA warning letters include "It’s basically an oral sunscreen … This would be especially useful for people who have had skin cancer, are at risk for skin cancer.” The firms FDA warned are Isocell North America Inc., Sunergized LLC, Pharmacy Direct Inc. and Napa Valley Bioscience LLC.

Dietary Supplements FDA

Spray Sunscreens Stay In FDA Enforcement Discretion Shade

CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.

Regulation Drug Approval Standards

FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

It’s known that challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

Regulation FDA

NAFTA’s Been Good To Cosmetics And Could Get Better, But Stars Are Not Aligning In 2018

It appears that hopes may be dashed for a fast-tracked NAFTA update, putting the trade agreement’s future in question. The cosmetics industry has much to gain from the reboot, which stands to include an annex promoting regulatory best practices and other principles for "cost savings and greater competitiveness for our industry," according to PCPC leadership.

North America Trade

Capitol Hill Calm On Regulatory Front Before Mid-Term Elections Storm

Federal agencies have “put brakes on new regulations” during the Trump administration and made efforts toward deregulation across the board, bringing about a “good and friendly environment for most businesses and industries,” says lobbyist Pete Evich. “We need to be careful about complacency that has a tendency to creep back in at a time like this when direct attacks and threats are down,” he said in a recent webinar.

Regulation Manufacturing

Carmex Cold Sore Treatment Claims Exceed Monograph Limit In NAD Review

Carma Labs’ Carmex Cold Sore Treatment claims did not mirror language in two OTC monographs for its active ingredients, the National Advertising Division says in a review of packaging and advertising claims challenged by GlaxoSmithKline's consumer business.

Regulation Consumer

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Capitol Hill Calm On Regulatory Front Before Mid-Term Elections Storm

Federal agencies have “put brakes on new regulations” during the Trump administration and made efforts toward deregulation across the board, bringing about a “good and friendly environment for most businesses and industries,” says lobbyist Pete Evich. “We need to be careful about complacency that has a tendency to creep back in at a time like this when direct attacks and threats are down,” he said in a recent webinar.

Regulation Manufacturing

OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

Regulation Consumer

OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns

Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.

Regulation Consumer

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SPF Claims No More Reliable In 2018 Than Previous Years – Consumer Reports

The nonprofit publication’s 2018 sunscreen ratings and buying guide reflect its own SPF testing in which a third of sunscreens again underperformed dramatically compared with labeled SPFs. Low-scoring brands may face a new wave of false-advertising litigation, with many related suits still pending in federal and state courts.

Legal Issues Advertising, Marketing & Sales

Rodan + Fields Concealed Prostaglandin Risks From Lash Boost Users – Class Action

Marketers of cosmetic lash enhancers that haven’t abandoned prostaglandin analogs in favor of peptides or botanical extracts should take heed of a proposed class action against Rodan + Fields in California’s Northern District. Plaintiffs say they would not have purchased the firm’s Lash Boost and suffered alleged adverse effects if they’d been properly informed about product risks.

Legal Issues Advertising, Marketing & Sales

‘Hypoallergenic’ Class Actions Bubbling Up: The New ‘Natural’ Scourge?

There are similarities between trending “hypoallergenic” class actions and “natural” litigation that for years has been the bane of many leading brands and a cash cow for plaintiffs.

Advertising, Marketing & Sales Legal Issues

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Petite Planet Baby Care, Listerine Sensitivity Rinse Top J&J's Consumer Growth Strategy

J&J will launch a Listerine mouthwash in a formulation considered a medical device and indicated for tooth sensitivity and enter the premium baby care segment with the Petite Planet line. It plans to launch 150 products globally in 2018.

Commercial Advertising, Marketing & Sales

Lauder Rides Asia, Skin-Care Momentum In Q3; Sales Up 18%

Firm’s skin-care business rose 31% in the third quarter, taking considerable weight off makeup, which faces leveling demand after the boom in recent years. With its “digital-first mindset,” Lauder plans to increase promotional investments substantially in the fourth quarter to hit the ground running in fiscal 2019.

Business Strategies Sales & Earnings

Capitol Hill Calm On Regulatory Front Before Mid-Term Elections Storm

Federal agencies have “put brakes on new regulations” during the Trump administration and made efforts toward deregulation across the board, bringing about a “good and friendly environment for most businesses and industries,” says lobbyist Pete Evich. “We need to be careful about complacency that has a tendency to creep back in at a time like this when direct attacks and threats are down,” he said in a recent webinar.

Regulation Manufacturing

Ingredients Explore this Topic

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CIR Defends Independence, Suggests Confusion Prompted WVE Criticism

Cosmetic Ingredient Review head Bart Heldreth suggests that not only are Women's Voices for the Earth's concerns misguided, but the group may hold a grudge from past instances when the CIR Expert Panel was in disagreement with the group. Heldreth maintains the expert panel “has established a strong record of protecting public health through its reviews and safety assessments of ingredients used in cosmetics.

International United States

CIR Objectivity In Safety Substantiation Questioned By Women's Voices for Earth

In a report released April 24, WVE highlights what it says are CIR’s shortcomings, pointing out a conflict of interest due to the group’s industry funding and governance, as well as its narrow scope solely focused on consumer safety – not the safety of workers or environmental impact – and the expert panel’s approach to inhalation hazards and data gaps.
International United States

Hawaiian Sunscreen Ban On Brink Of Passage; Lawmakers Hashing Out Final Details

Conferees from the state’s House and Senate will meet in an effort to resolve differences in legislation to ban the sale of oxybenzone- and octinoxate-containing sunscreens due to environmental concerns. A consensus version of the bill must be available for final reads by April 26.

Cosmetic Ingredients Legislation

Dietary Supplements Explore this Topic

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Supplement Firms Making Sunscreen Claims Warned In FDA Crackdown

Claims that rendered the firms' products unapproved new drugs and were listed in FDA warning letters include "It’s basically an oral sunscreen … This would be especially useful for people who have had skin cancer, are at risk for skin cancer.” The firms FDA warned are Isocell North America Inc., Sunergized LLC, Pharmacy Direct Inc. and Napa Valley Bioscience LLC.

Dietary Supplements FDA

Capitol Hill Calm On Regulatory Front Before Mid-Term Elections Storm

Federal agencies have “put brakes on new regulations” during the Trump administration and made efforts toward deregulation across the board, bringing about a “good and friendly environment for most businesses and industries,” says lobbyist Pete Evich. “We need to be careful about complacency that has a tendency to creep back in at a time like this when direct attacks and threats are down,” he said in a recent webinar.

Regulation Manufacturing

Health, Beauty And Wellness News: POM Wonderful On 'Health Scare' Swim In Ad

Online, pamphlet claims trip Baker's Best; MusclePharm maintains turnaround progress; Kameka enters probiotic market through AB-Biotics; and POM Wonderful ad swims on humor.

Dietary Supplements Advertising, Marketing & Sales
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