The Conkle Firm is at Cosmoprof Asia, Hong Kong

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Conkle, Kremer & Engel attorneys John Conkle and Sherron Wiggins are busy at Cosmoprof Asia in Hong Kong. CK&E is again the proud sponsor of California Trade Alliance’s California Pavilion, providing the meeting lounge so California businesses can be in the room where it happens.

The first day for CK&E at Cosmoprof Asia was largely devoted to catching up with old friends of the firm and meeting new ones. Many of the attendees have been CK&E clients or employees of clients for years. One such person is Greg Starkman who, as an executive of Joico in the early 90’s, worked with CK&E on numerous matters. Greg and his wife Joanne now head up Innersense Organic Beauty, which manufactures and sells a line of natural and organic hair care products “dedicated to purity, peace of mind, and the practice of self-care.”

We also viewed outstanding and innovative products that are finalists for the annual Cosmoprof Asia Awards. Several caught our attention, including two products selected due to their packaging. One uses a container made of recycled coffee grounds and polylactic acid (aka polylactide or PLA), which is a thermoplastic aliphatic polyester derived from renewable resources that gives the package a small carbon footprint. The other notable package is manufactured from industrial waste. Other innovative products of interest include a hair dryer weighing only .6 lbs, and a patented plastic makeup container that features a magnetic closure.

So far, attendance at this year’s Cosmoprof Asia appears to be reduced from last year. Many of the attendees believe that the reduced attendance may be affected by the citizen protests that have taken place in Hong Kong over the past few months. Some attribute the attendance drop-off more specifically to the reluctance of Chinese citizens from the “Mainland” to come to Hong Kong during the protests. But there’s a bright side to the smaller crowds – CK&E attorneys have more time available to meet with clients and prospective clients, and to learn about the new products and trends in the beauty industry.

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FTC Warns Manufacturers About CBD Claims

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The Federal Trade Commission (FTC) announced today that it had sent warning letters to three companies over their advertising of products containing cannabidiol or CBD, one of the many active compounds of the cannabis plant. The letters reinforce the FTC’s position that advertisers may not make health-related representations for CBD products without satisfying FTC substantiation standards.

According to the FTC’s press release, the companies – which have not been identified publicly – advertised oils, tinctures, capsules, “gummies” and creams containing CBD as treating or curing serious diseases and health conditions. Disease claims require scientific proof, making it illegal for companies to advertise that a product can prevent, treat or cure human disease without competent and reliable scientific evidence to support such claims.

The FTC took issue with the following:
• A claim that CBD “works like magic” to relieve “even the most agonizing pain” better than prescription opioid painkillers
• A claim that the company has participated in “thousands of hours of research” with Harvard researchers, to bolster its claims that CBD has been “clinically proven” to treat cancer, Alzheimer’s disease, multiple sclerosis (MS), fibromyalgia, cigarette addiction, and colitis
• A claim that CBD products are proven to treat autism, anorexia, bipolar disorder, post-traumatic stress disorder, schizophrenia, anxiety, depression, Alzheimer’s disease, Lou Gehrig’s Disease (ALS), stroke, Parkinson’s disease, epilepsy, traumatic brain injuries, diabetes, Crohn’s disease, psoriasis, MS, fibromyalgia, cancer, and AIDS
• A claim that CBD is a “miracle pain remedy” for both acute and chronic pain, including pain from cancer treatment and arthritis
• A claim that CBD gummies are highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders”
• A claim that CBD cream relieves arthritis pain
• A claim that CBD oil may effectively treat depression, PTSD, epilepsy, heart disease, arthritis, fibromyalgia, and asthma

According to the FTC, the letters urge the recipient companies to review all claims made for their products, including consumer testimonials, to ensure they are supported by competent and reliable scientific evidence, and also include a warning that selling CBD products without such substantiation could violate the FTC Act and may result in legal action that could result in an injunction and an order to return money to consumers.

The recent warning letters follow similar joint warning letters issued by the FTC and the U.S. Food and Drug Administration (FDA) in March 2019 to three sellers of CBD supplements – Nutra Pure LLC, PotNetwork Holdings, Inc., and Advanced Spine and Pain LLC d/b/a Relievus. The letters alleged that the companies made false or unsubstantiated health claims in violation of the FTC Act as well as sold unapproved drugs in violation of the Federal Food, Drug & Cosmetic Act (FD&C Act).

As the market for CBD goods – including cosmetics and supplements – continues to explode, companies vying for market position must be aware of action taken by the FTC and FDA and stay away from making health or drug claims that could subject them to enforcement by these agencies. Conkle, Kremer & Engel attorneys stay current on the latest developments to help those how manufacture, distribute and sell products containing CBD avoid regulatory trouble.

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Will 2019 be the Year of Federal Cosmetics Regulation?

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2019 is starting to look like the year Congress may make good on its efforts to pass federal cosmetics reform legislation, with legislation in the works in both the U.S. Senate and the U.S. House of Representatives that would increase federal regulatory oversight for cosmetics. In addition, Senate and House committees have been active in demanding more information and action from the Food and Drug Administration (FDA) to ensure cosmetics safety.

Feinstein/Collins Personal Care Products Safety Act Bill

As they have in previous sessions of Congress, Sens. Dianne Feinstein (D-California) and Susan Collins (R-Maine) re-introduced the “Personal Care Products Safety Act” (S. 726) in March, a bill that would strengthen the FDA’s efforts to regulate ingredients in personal care products.

The Personal Care Products Safety Act bill would amend the Federal Food, Drug & Cosmetic Act (FDCA) by:

  • • Requiring annual registration of cosmetic facilities with the FDA and impose tiered registration fees;
  • • Requiring cosmetic ingredient statements for all cosmetics, including fragrances, flavors and colors, as well as a range of possible amounts of each ingredient;
  • • Providing the FDA the authority to suspend registration of a facility (and any import, export or distribution of cosmetics from the facility) or a cosmetic ingredient statement (and all cosmetics that are the subject of the statement) if there is a reasonable probability of serious adverse health consequences or death to humans;
  • • Directing the FDA to review ingredients and non-functional constituents, including coal tar chemicals) for safety at a rate of at least five ingredients per year;
  • • Directing the FDA to issue regulations to establish Good Manufacturing Practices for cosmetics;
  • • Requiring timely reporting of serious adverse events and annual reporting of adverse events;
  • • Allowing the FDA wide authority to inspect records;
  • • Providing mandatory recall authority to the FDA;
  • • Requiring labeling of cosmetics that are not appropriate for use in the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product;
  • • Requiring ingredients, warnings and statements on professional products;
  • • Requiring complete label information to be placed online for online sales of cosmetics; and
  • • Requiring a telephone number or electronic contact information on the label.

In the first year, the FDA would evaluate the safety and appropriate use of the following five chemicals, which could be banned from cosmetics or limited in their allowed use:

• Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
• Diethyl phthalate, which is used as a binding agent in some fragrances and cosmetics.
• Methylene glycol/formaldehyde, which is used in hair treatments.
Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion.
• Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.

Pallone/Shimkus Discussion Draft

Meanwhile, House Energy & Commerce (E&C) Committee Chairman Frank Pallone Jr. (D-NJ) and Rep. John Shimkus (R-Ill.) in March released a bipartisan discussion draft of legislation that is very similar to the Personal Care Products Safety Act, which is expected to be introduced in the House soon.

Action by Congressional Committees

Congressional committees have also been flexing their investigative and oversight muscles by demanding additional information from and calling for more action by the FDA, separately from the status of any reform legislation.

After the FDA announced in March that its testing (almost two years after the fact) confirmed the presence of asbestos in cosmetics, including eye shadows, compact powders and contour palettes, sold in 2017 at children and teen stores Claire’s and Justice stores, Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called for further investigation by the FDA into whether cosmetic products that contain talc “may be contaminated with asbestos.”  Sen. Murray is also urging the FDA to conduct additional testing to ensure the safety of cosmetic products containing talc, and in particular cosmetics that are marketed to children and teenagers.  Separately, Sen. Murray demanded that Claire’s provide more information about the possible sources of asbestos contamination and the process and procedures Claire’s takes to assess the safety of its products before they reach customers.

There have been further regulatory and legislative developments on these subjects in June 2019. Additional cosmetics, including a JoJo Siwa makeup set sold by Claire’s, were found to be contaminated with asbestos and were recalled in June 2019. Rep. Pallone then sent a letter to the FDA requesting updated information about the agency’s inspections of imported cosmetic products. Specifically, Rep. Pallone sought FDA foreign inspections data from Fiscal Year (FY) 2017-2019, including the number and kinds of personal care products imported each year, the number of imported products subjected to inspections each year, and the number of contaminated products intercepted each year. According to Rep. Pallone, the FDA has not conducted any foreign cosmetic inspections in FY 2019 and intends to conduct no foreign cosmetic inspections in FY 2020.

This was not the first such request to the FDA, as Rep. Pallone previously sent a letter to the FDA requesting similar information in 2016. In response, the FDA stated that in FY 2016, less than one percent of cosmetic products that arrived in U.S. ports were physically examined by FDA inspectors; of those inspected, inspectors reported adverse findings such as illegal color additives and microbial contamination in 15 percent of the imports.

The push toward federal cosmetics reform has been many years in the making, and now gathers industry support from such heavyweights as The Estee Lauder Companies, Johnson & Johnson, L’Oreal and Procter & Gamble.  While the industry by and large appears to agree that updates are needed to the current regulatory system and would increase consumer confidence, there are concerns about the extent of the reform and the scope and breadth of the power to be vested in the FDA.  Key stakeholders are involved in the process and engaging with the House, Senate and FDA. 

While it remains to be seen whether 2019 will be the year of significant cosmetic legislation reform, one thing is certain – increased regulation for the personal care products industry is inevitable, and the question is just one of how much regulation and the extent to which the FDA will preempt state and local regulations.

Cosmetics manufacturers should take heed as they plan their product formulations, manufacturing and labeling of existing and planned product lines, whether made in the U.S. or abroad. Conkle, Kremer & Engel attorneys stand ready to help clients plan their responses to current and developing regulatory changes affecting the beauty industry.

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Conkle Firm Attorneys and PCPC Lobby California Legislature about SB 574 and AB 495

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On April 3, 2019, Conkle, Kremer & Engel attorneys John Conkle and Raef Cogan joined the Personal Care Products Council (“PCPC”) in Sacramento, California to lobby members and staff of the California Legislature on pending legislation important to members of the personal care products industry, including Senate Bill 574 and Assembly Bill 495.

CK&E attorneys, PCPC staff and participating industry representatives visited legislative offices to advocate for positions favored by personal care products industry members. Over the course of more than 15 meetings with legislators and their aides, the group focused its advocacy on two pending bills that, if enacted, would have significant consequences for the U.S. cosmetics industry as a whole. Conkle, Kremer & Engel has previously written about Senate Bill No. 574 (“SB 574”) introduced by Senator Connie Leyva and Assembly Bill No. 495 (“AB 495”) introduced by Assembly Members Al Muratsuchi and Buffy Wicks. These are important bills that if enacted would have significant consequences for the U.S. cosmetics industry as a whole.

SB 574, also known as the “Toxic Fragrance Chemicals Right to Know Act of 2019,” would require cosmetic manufacturers to disclose fragrance of flavor ingredients that appear on any one of 27 “designated lists.” CK&E attorneys explained during the meetings that a viable version of this bill may be presented in the future, but that as written SB 574 threatens cosmetic companies’ confidential business information, results in duplicative regulation and relies on faulty, unscientific “lists” to determine what information manufacturers must disclose.

AB 495, is entitled the “Toxic Free Cosmetics Act,” and would dramatically increase the number of cosmetics listed as “adulterated,” without justification. CK&E attorneys explained that under AB 495 as proposed, any cosmetic that contained even trace amounts of identified ingredients would be labeled “adulterated” and would be banned outright. Some ingredients sound scary, like lead, but are in fact naturally occurring and cannot be completely eliminated from cosmetic (or many other) products. Others are preservatives that have been deemed completely safe for use in cosmetics by the FDA and other regulatory bodies.

Both SB 574 and AB 495 are coming up for committee vote soon. Conkle, Kremer & Engel will stay apprised of the results and will provide updates on this legislation that is important to the cosmetics industry.

PCPC California Lobby Day also featured presentations from Allen Hirsch, Chief Director of the California Office of Environmental Health Hazard Assessment (“OEHHA”), Karl Palmer from the Department of Toxic Substances Control (“DTSC”), Joseph Calavita from the Air Resources Board, and Senator Bill Quirk, Chair of the Environmental Safety and Toxic Materials Committee. The regulators spoke about important upcoming actions by their agencies. Senator Quick focused on the importance of protecting our environment from toxins, primarily greenhouse gasses. Each of these presenters stressed a need for more information sharing between the industry and the respective regulatory and legislative bodies.

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California’s SB 574 and AB 495 Would Expand Regulation of Cosmetics Labeling and Ingredients

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California has always led the way when it comes to regulating cosmetic products, and bills recently introduced by Senator Connie Leyva (Senate Bill No. 574 or SB 574) and Assemblymembers Al Muratsuchi and Buffy Wicks (Assembly Bill No. 495 or AB 495) is in keeping with California’s reputation as a trailblazer in the cosmetics regulatory space.

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019”

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019,” was introduced last month. It would require cosmetic manufacturers, starting July 1, 2020, to disclose whether any of their cosmetic products contains a toxic fragrance or flavor ingredient.

Fragrance or flavor ingredients that appear on any one of 27 “designated lists” would be subject to public disclosure. The designated lists include chemicals listed as known to cause cancer or reproductive toxicity pursuant to California’s Proposition 65; chemicals classified by the European Union as carcinogens, mutagens or reproductive toxins; chemicals included in the European Union Candidate List of Substances of Very High Concern; and Group 1, 2A or 2B carcinogens identified by the International Agency for Research on Cancer (IARC) among many others.

Existing law – the California Safe Cosmetics Act of 2005 (“Safe Cosmetics Act”) – requires cosmetic manufacturers to disclose to the California Department of Public Health (CDPH) Safe Cosmetics Program whether any of their cosmetic products contain chemicals known or suspected to cause cancer or reproductive toxicity. The Safe Cosmetics Act’s list of reportable ingredients is compiled from a more far limited set of five designated lists. This self-reported information, in turn, is publicly available through the CDPH’s Safe Cosmetics Database.

While the Safe Cosmetics Act does not exempt fragrances and flavorings from being reported, the reportable chemicals in those cases are often identified simply as “trade secrets.” The proposed legislation would require the disclosure of the identities of the reportable chemicals or ingredients, but for trade secret purposes, would not require the weight or amount of a fragrance or flavor ingredient to be disclosed or any disclosure of how the fragrance or flavor is formulated. In addition, a manufacturer would not have to disclose any fragrance or flavor ingredients that are not found on any of the 27 designated lists. It is important to note that SB 574 as proposed would not ban or otherwise regulate the use of any fragrance or flavor ingredients.

AB 495, the “Toxic Free Cosmetics Act”

AB 495, also introduced in February 2019, would amend both California’s Sherman Food, Drug and Cosmetic Law and the Safe Cosmetics Act.

California’s Sherman Food, Drug and Cosmetic Law prohibits the manufacture, sale, delivery, holding or offer for sale of adulterated cosmetics. AB 495 would greatly expand the definition of an “adulterated cosmetic” to include cosmetics that contain specific ingredients. Any cosmetic that contains lead or asbestos or any of the following 13 intentionally added ingredients – without regard to the amount or exposure levels – would be banned from sale in California:

  • Butylparaben
  • Carbon black
  • Dibutyl phthalate
  • Diethylhexyl phthalate
  • Formaldehyde
  • Formaldehyde releasers
  • Isobutylparaben
  • Isopropylparaben
  • Mercury and related compounds
  • Per- and Polyfluoroalkyl substances (PFAS)
  • Propylparaben
  • Toluene
  • Triclosan

The bill would also amend the Safe Cosmetics Act by requiring referrals to be made to the Department of Justice for any sale of adulterated cosmetics, as well as any violation of the Safe Cosmetics Act.

If passed, the legislation would have the effect of requiring companies doing business anywhere in the United States to reformulate their cosmetics to remove these ingredients, effectively creating a nationwide ingredient ban. The bill comes as the FDA confirmed that cosmetic products sold in 2017 by Claire’s and Justice tested positive for asbestos.

It has become clear that California’s leadership position on cosmetic regulation has effectively driven changes in cosmetic products and labeling throughout the United States. Conkle, Kremer & Engel will continue to follow and update these important developments affecting the cosmetics industry.

Update on AB 495 as of April 9, 2019

Efforts to pass AB 495 have temporarily stalled.  On April 9, 2019, the Assembly’s Environmental Safety and Toxic Materials Committee postponed a scheduled vote to move the bill to the Assembly Health Committee due to lack of support.  The bill is not expected to be brought back again until next year. It is anticipated that the bill will be in a revised form when reintroduced.  Conkle, Kremer & Engel will continue to monitor the developments of AB 495.

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Manufacturers, Suppliers and Resellers Must Plan for California’s New Cruelty Free Cosmetics Act

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Almost no one favors animal testing for cosmetics.  The beauty market trend has been strongly away from animal testing, as demonstrated by the recent announcement of Coty, Inc.’s CoverGirl brand being certified cruelty free.  That’s why the personal care products industry supported California’s new Cruelty Free Cosmetics Act, SB 1249, which was unanimously passed by the California State Assembly and signed into law by Governor Brown on September 28, 2018.  The new Act does not take effect until January 1, 2020, but compliance will require cosmetics businesses to plan ahead.  The new Act may present some thorny and perhaps unexpected issues and risks for importers, manufacturers, distributors and resellers of beauty products and ingredients in California.

The new Act is found at Section 1834.9.5 of the California Civil Code, immediately following the existing animal testing law that has been in effect since 2000.   That existing law, Section 1834.9, continues to prohibit manufacturers and testing facilities from using animal testing when alternative methods have been scientifically validated and recommended by responsible agencies.  But the existing law has limited application, and the new Act significantly expands on the prohibitions of animal testing for cosmetics and their ingredients.

Generally, the Act prohibits a manufacturer from importing, offering or selling in California any cosmetic that “was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020,” with specified exceptions.  The first observation must be that the new Act will not apply to any manufacturer’s cosmetic or ingredient that was previously subject to animal tests.  The natural effect is that the Act generally does not apply to a manufacturer’s existing cosmetic ingredients and product formulations, even if the cosmetic or ingredient is manufactured after January 1, 2020.

However, manufacturers and importers need to note that the Act certainly can affect development of new cosmetic formulations, and so it will have a strong impact on use of innovative cosmetic ingredients in new or reformulated products.  This can impede participants in the personal care products industry who strive to develop new ingredients to improve and differentiate their products.  Scientifically-reliable alternative non-animal test methods can be slow to develop and receive approval by regulatory agencies, so the inability to conduct animal testing could inhibit the introduction of new cosmetic ingredients, particularly potentially complex ingredients such as new surfactants or polymers.

There are some exceptions to application of the new Act, but they may defy easy workaround solutions.  The first major exception is a multi-step assessment that exempts application of the Act if the manufacturer can establish all of these elements:

  1. An animal test is required by a U.S. federal or state regulatory authority, and no non-animal alternative testing method is acceptable;
  2. The ingredient tested is in wide use and cannot be replaced by another ingredient with similar function; and
  3. The need to conduct animal tests is justified to address a specific substantiated human health problem and supported with a detailed research protocol.

The multiple elements required for this exception are so demanding that its practical utility is doubtful.  But there are two additional exceptions that on first blush appear deceptively simple to apply:  First, if animal testing is required by a foreign regulatory authority for export to that country, the animal-tested product does not for that reason violate the new Act.  This was an important exception favored by the industry, because without it cosmetic products could not be readily exported to foreign markets, like China, that require animal testing.  The second exception applies if animal tests were required to be performed on an ingredient for non-cosmetic purposes.  In other words, if some animal testing was done on the ingredient for non-cosmetic purposes, or was required for exporting the product, that animal testing in itself will not preclude use of that ingredient in a cosmetic product.

On their face, these last two exceptions seem like they create large loopholes in the Act.  But looks can be deceptive.  Both of these exceptions are narrowed by an additional term that prohibits the manufacturer from relying on evidence of the animal testing to substantiate the safety of cosmetics sold in California.  California and the FDA require that “Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing.”  (21 CFR 740.10(a))  There are few meaningful guidelines about what “adequate substantiation” of safety means, or exactly what records are required to be maintained to show such substantiation, but it is clear such substantiation must exist “prior to marketing.”

So the effect of the new Act is to prohibit manufacturers offering products in California from relying on animal testing as part of their “adequate substantiation of safety” before selling their products, even though the animal testing itself did not violate the Act due to the noted exceptions.  This limitation effectively requires manufacturers to somehow show separate, non-animal testing to have adequate substantiation of the safety of their ingredients and products prior to marketing.  That in turn renders the animal testing that was permitted under the exceptions useless to support the safety of cosmetic sales in the California market.

The safety substantiation requirement has yet another twist that may present a significant risk to manufacturers selling cosmetics in California after the new Act becomes effective:  Although no federal or California state law specifies how or what documentation of safety must be maintained, the new Act both permits and motivates district attorneys and city attorneys, upon their determination of “a reasonable likelihood of a violation,” to “review the testing data upon which a cosmetic manufacturer has relied in the development or manufacturing” of the product sold in California.  Given that violators can be fined $5,000 initially plus $1,000 per each day that a violation continues, which fines are payable directly to the city or county attorney’s office, district attorneys and city attorneys have powerful motivation to aggressively pursue possible violations.

It seems the legislature was sufficiently concerned about this “adequate substantiation” issue that it was felt necessary to specify in the Act that a manufacturer “is not prohibited from reviewing, assessing or retaining evidence from an animal test conducted” for non-cosmetic purposes (though, oddly, the Act says nothing about that for the separate “foreign regulatory” exception).  So just having an animal test in the manufacturer’s file may not violate the Act, but the manufacturer still cannot rely on those tests when a DA or city attorney comes calling.  Manufacturers must determine how they will maintain records to show adequate substantiation of the safety of all of their ingredients and product formulations, prior to marketing, without running afoul of the Cruelty-Free Cosmetics Act.

The new Act does not itself create a new private legal claim, which means that (unlike some other California consumer protection statutes like Proposition 65) bounty-hunter plaintiff lawyers will not have direct motivation to pursue claims under the Act.  However, that has not stopped creative plaintiffs’ attorneys from bootstrapping other consumer product regulatory violations as bases for civil lawsuits, such as “Unfair Business Practices” claims under Business & Professions Code Section 17200 et seq., and even class actions under the Consumer Legal Remedies Act (CLRA), California Civil Code Section 1750.  It is also not difficult to imagine competitors making claims of unfair competition based on allegations that a competing cosmetics brand violated California’s animal testing laws, perhaps including false advertising claims for good measure.

Cosmetics manufacturers and their suppliers have a little over a year to ensure that their cosmetics and ingredients made, imported or sold in California will be compliant with the Cruelty Free Cosmetics Act.  More challenging still, manufacturers, importers and ingredient suppliers will have to plan for development of new cosmetics and ingredients, with adequate substantiation of their safety that does not depend on animal testing results. Conkle Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate California’s fast-changing regulatory landscape.  If you have questions in this or other consumer product regulatory areas, contact CK&E at counsel@conklelaw.com or 310 998-9100.

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What do Goop, Sexual Energy, Jade Eggs and CBD Have in Common?

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Answer: Unproven Health Claims

Goop, a life-style branding company founded by Gwyneth Paltrow, was recently fined $145,000 by a consortium of California Counties for making exaggerated and false advertising claims about its products.  The makers and distributors of everything from clothes to perfume, and face cream to condoms, Goop has a well-documented history of over-the-top marketing claims.  In the action brought by the County District Attorneys, the government took exception to the claim made by Goop regarding its Jade Egg product.  Goop claimed among other things that the egg product, when inserted into the vagina, prevented uterine prolapse and improved sex.  In the parlance of the regulators, this was an unsubstantiated or unapproved new drug claim.

In similar fashion, cannabidiol oil or “CBD” products are at the forefront of aggressive (sometimes overly aggressive) health and medical claims. Everyone knows about “medical” marijuana, and CBD is one of several “active” ingredients found in marijuana and hemp plants which is often associated with the beneficial effects of the plant: pain relief, stress or anxiety relief, anti-nausea, and anti-inflammatory.  This phenomenon has lead to a budding market in consumer products featuring CBD, accompanied by assertive health claims.  The CBD market already covers a wide range of products, including cosmetics (skin creams), food products  (edibles), and even CBD laced beer.  To add to the confusion, a compound found in marijuana was recently approved by the FDA for treatment of a rare seizure disorder.

And this highlights the problem, especially for marketers of cosmetics.  The only FDA-approved medical claim for marijuana compounds is directed to a rare seizure disorder, and this is a tiny market. To make a valid advertising claim that a  skin cream product treats, for example, eczema, psoriasis or a rash, the company or brand would need to have FDA approval of the active ingredient for that particular disease or condition at issue.  Absent such approval, the marketing claim would likely be regarded as an unapproved new drug and subject to regulatory fines and seizure.  Thus, for example, if you want to make a skin-protectant claim for your product, you would need to use one of the FDA approved ingredients for such claims, and limit the claim to the language approved in the FDA monograph for skin protectants.  To illustrate the point, witch hazel is one of the FDA approved skin protectant active ingredients. If you use witch hazel as an ingredient in your product, in the correct percentage, it would allow you to make the claim “[r]elieves minor skin irritations due to either i) insect bites, ii) minor cuts, and/or iii) minor scrapes”.

The point of all this is to make sure that your advertising claims are reviewed and approved by experienced legal counsel.  This is a common area for regulatory action, as well as private class actions.  The FDA routinely polices the internet looking for unsubstantiated and unapproved new drug claims. When the FDA finds a violation, it sends out a warning letter that will look something like this.  You do not want to be the first one on your block to own one of these.  Consult your CK&E attorney before you put a label on your product, make an advertising claim on your website, press send on an email blast promotion, or even drop a product catalog in the mail.  Yes, even old school mailers can get you in trouble.

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New Law Requires Professional Cosmetics Labels to List Ingredients

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Professional cosmetics sold in California must have full ingredient labeling in the same manner as consumer cosmetics, if the products are manufactured after July 1, 2020.  The California legislature unanimously approved AB 2775, introduced by Assembly Member Ash Kalra.  The bill was signed into law by Governor Brown on September 14, 2018 and enacted as new Section 110371 to the Health and Safety Code.

There are over 312,000 professional cosmetologists who are licensed to provide nail and hair services, most often in salons.  The legislature found that “[i]nformation on the ingredients in professional salon products is essential to ensuring that workers and owners can make safer product choices and take steps to protect themselves and their customers against harmful exposures.”

The new law will establish that professional cosmetics must have a label affixed on the container that satisfies all of the labeling requirements for any other cosmetic pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301, et seq.), and the federal Fair Packaging and Labeling Act (15 U.S.C. Sec. 1451, et seq.).  In other words, professional cosmetics must have the same ingredient labeling as consumer cosmetics.

The law already defines the term “cosmetic” as “any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  (Health and Safety Code Section 109900)  The newly-enacted law introduces a new definition of “professional cosmetic,” meaning a cosmetic “that is intended or marketed to be used only by a professional on account of a specific ingredient, increased concentration of an ingredient, or other quality that requires safe handling, or is otherwise used by a professional.”  In turn, “professional” is defined for this purpose as “a person that has been granted a license by the State Board of Barbering and Cosmetology to practice in the field of cosmetology, nail care, barbering, or esthetics.”

There is arguably some ambiguity in that the new statute could be read to define a “professional cosmetic” in a circular manner as including a cosmetic that “is … used by a professional.”  Such an ambiguity is not likely a concern in this particular Act.  This is because the effect of this new law is just to require the same type of ingredient labeling for both consumer and professional cosmetics, so it should not matter whether a licensed professional uses a resalable consumer or professional cosmetic for purposes of compliance with this law.  However, if in the future the same definition of “professional” is incorporated into other enactments (much like “the definition of cosmetics” was incorporated here from a different statute), the circular definition may become more problematic.

The new law was enacted with widespread industry support, including the Personal Care Products Council, the Professional Beauty Association, California Chamber of Commerce, and Unilever.  Many manufacturers have already listed product ingredients on their professional cosmetic lines in a manner consistent with that required for retail cosmetics, and so may already be in compliance.  But manufacturers should review their professional cosmetic product labeling well ahead of the July 1, 2020 effective date in order to determine whether they comply.  Further, manufacturers should be aware that there is no specific “professional cosmetic” exception to other warning label requirements, such as Proposition 65, which requires warnings if use of a product on a consumer in California would result in significant exposure to identified chemicals that are known to cause cancer, birth defects or other reproductive harm.

Manufacturers are well-advised to seek qualified counsel to review their circumstances before committing to potentially costly label changes, to be sure they comply with all legal requirements.  Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the professional salon products industry, and are ready to help clients apply navigate the changing regulatory landscape in California and elsewhere.

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CBD is Turning Up Everywhere – But is it Allowed?

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One of the hottest trends in many industries is the addition of cannabis-derived extracts to consumer product formulas.  This is likely driven by the widespread popularity of local and state attempts to legalize medical or recreational marijuana use.  The personal care product industry is no exception to the trend, as any number of new product lines from moisturizers to mascara are being released with cannabis extracts in their formulations.  Cannabidiol (CBD) is turning up in all types of consumer food and drink products, from honey to craft beers.Honey with CBD

The cannabis plant contains over 113 known cannabinoids, or naturally-occurring compounds that interact with receptors in the human body, including cannabidiol (CBD) and THC. Since psychoactive effects are often attributed to the THC ingredient, it is generally avoided in consumer products, but CBD is considered to have no psychoactive properties and is becoming a popular ingredient, as is its cousin, hemp seed oil.  Some believe CBD can have health benefits – but more about that later.  In the current confusing state and federal legal environment concerning marijuana, many consumer product companies are wondering, is it legal to include CBD in my products?  The short answer is no. The long answer is “it’s complicated.” And the most important answer is that the environment is changing fast, so in the near future the question may become moot.

To understand the current complications, a little background on cannabis extracts is essential.  First, hemp and marijuana are both varieties of the cannabis sativa plant.  Various cannabis extracts can be sourced from different parts of the cannabis plant in a variety of ways. The most common cannabis extracts used in personal care and many other products are hemp seed oil and CBD oil. Hemp seed oil is produced by cold-pressing the seed of a hemp plant, while CBD oil is generally produced from the leaves and flowering tops of either a marijuana plant or a high-CBD hemp plant. Marijuana has high amounts of THC, the psychoactive ingredient that produces the “high” of marijuana. Hemp, on the other hand, typically contains only trace amounts of THC, but can be bred to have high amounts of CBD. While hemp seed oil differs from CBD oil, the legality of the two are intertwined. In short, hemp seed oil imported from abroad is legal, while hemp seed oil sourced from hemp grown in the United States may be legal in certain circumstances. CBD oil, on the other hand, is at present illegal under federal law under all circumstances.

Sterilized seeds and oil and cake made from the seeds of the cannabis plant (we’ll refer to these as “Hemp Oil” for the sake of simplicity) do not fall under the purview of the Controlled Substances Act (the CSA), which regulates federal U.S. drug policy. Hemp Oil is not deemed to be a controlled substance, so the production, distribution and possession of Hemp Oil is legal.  However, there are heavy regulations on the cultivation of “industrial hemp” (cannabis plants with THC concentration <0.3% by dry weight) from which Hemp Oil is derived. In simplified terms, Hemp Oil must be either imported into the U.S. or derived from industrial hemp legally grown pursuant to a 2014 Farm Bill. Pursuant to the 2014 Farm Bill, industrial hemp may only be grown for commercial purposes under specific pilot programs that have been adopted in particular states.

Unlike Hemp Oil, CBD is most easily derived from the leaves and flowering tops of cannabis plants.  CBD sourced from the leaves and flowering tops of the marijuana plant is illegal under the CSA, because the leaves and flowers of cannabis plants are not exempt from the definition of the CSA. But CBD can also be derived from industrial hemp, and since the passage of the 2014 Farm Bill it was commonly believed that CBD derived from legally grown industrial hemp would be legal. But it’s not that simple.  In 2017 the DEA implemented a final rule specifically targeting cannabinoid extracts, which includes CBD extract, regardless of its source. The final rule defined a new category of “marihuana extract” under the CSA that specifically rendered cannabinoid extracts a controlled substance illegal in general distribution and use. The DEA reiterated that any such cannabinoid extracts substance “will continue to be treated as Schedule I.”

The legality of the DEA’s new “marihuana extract” definition is questionable, but at present the new category of “marihuana extract” stands under the CSA, making CBD illegal under federal law. Hemp Oil is still legal and available for use in personal care products if imported into the US or grown pursuant to the state-licensed commercial hemp grower pilot programs. In May 2018, the DEA issued an internal directive acknowledging that products and materials made from the cannabis plant that fall outside of the CSA’s definition of marijuana (such as “sterilized seeds incapable of germination, and oil or cake made from the seeds”) can be “sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations.” But this directive does not make CBD legal in the DEA’s view.

Despite the dubious legal status of CBD oil and to a lesser extent Hemp Oil, many companies are choosing to forge ahead and add cannabis extracts to their products. Many such risk-takers believe that DEA enforcement against CBD-containing products is virtually nonexistent, and demand for consumer products containing CBD is high, so the potential risk is outweighed by perceived market benefits.

That conclusion is reinforced because there is a widespread perception that soon all these concerns could go up in smoke. Congress has begun action to remove industrial hemp from the definition of marijuana under the CSA. Such a move would also remove any extracts derived from hemp from the new definition of “marihuana extract.” Reports indicate that Congress may pass the bill before the end of 2018, effectively making CBD oil derived from hemp legal across the United States.  If that comes to pass, the product manufacturers who decided to jump the market and add CBD to their products even when it was legally dubious to do so may feel vindicated.

Honey with CBD Benefits ClaimedBut CBD is not a magic elixir that relieves brand owners from overreaching in their labeling and advertising.  In a future blog post, we’ll address the hazards of claiming health benefits from use of non-medical products, including those containing CBD.

Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate the fast-changing regulatory federal and state landscape.  If you have questions in this or other consumer product regulatory areas, contact CK&E at counsel@conklelaw.com or 310 998-9100.

 

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Making Your Mark in the Craft Beer Business, Part One – Identifying and Protecting Your Trademarks

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According to the Brewer’s Association there were over 6,000 craft breweries operating in the United States at the end of 2017. In an increasingly crowded market, how do you ensure that the craft beer consumer is able to distinguish your brewery from your competitors? You should begin by identifying your trademarks.

A trademark is any word, phrase, symbol or design that uniquely identifies the source of one company’s goods from those of other companies. While the law in the United States recognizes a broad range of “source identifiers” as trademarks, most companies focus their intellectual property protection efforts on brand names, slogans and logos. Especially at the early stages of your business, it is important to focus your protection efforts on the essential elements of your brand. For example, your brewery may have a dozen regular varieties of beer, plus several small release or seasonal brews throughout the year. Seeking trademark registrations for each of your beers may quickly deplete your legal budget, and so a more focused approach is usually the best course of action. For most breweries, their primary protection efforts should focus first on their brewery name and logos, and then on the names of one or two of their flagship beers.

In the United States, a brewery’s trademark rights arise at the time it starts using the mark in commerce. This means that the first person to begin using a trademark in connection with the sale of beer owns that mark, and may be able to prevent others from using confusingly similar marks on beer and beer-related goods and services. That is, a registration with the United States Patent and Trademark Office (USPTO) is not necessary to own a trademark. However, these “common law” rights are limited in that they can only be applied to the geographic area in which you are selling your beer. Any business that is serious about protecting its brand should seriously consider applying for registration of the essential names and logos.

Some of the benefits that federal trademark registration provides to the trademark owner include:

(1) Preventing infringement problems before they begin by making your marks easy to find in a search of marks registered with the USPTO;

(2) Getting the USPTO to do a degree of enforcement on your behalf by preventing the registration of other marks found to be confusingly similar by the USPTO’s examiners;

(3) Giving you nationwide priority when your marks might otherwise be limited to the geographic area in which you are using the mark;

(4) Putting other companies on notice of your trademark rights so that they cannot claim that their subsequent use of your mark was in “good faith;”

(5) Creating a presumption of validity and ownership of your mark in the event that you need to sue another company for infringing your trademark rights;

(6) Providing the ability to recover treble damages and attorney’s fees in “exceptional” cases of trademark infringement;

(7) Providing the ability to recover statutory damages in cases involving counterfeiting;

(8) Giving you the ability to file for “incontestability” after five years of registration, which severely limits other companies’ ability to invalidate your trademark;

(9) Empowering Customs and Border Protection to block imports that infringe your trademark rights, including counterfeit products, once you record your trademark registration with Customs; and

(10) Granting you the right to use the ® symbol in connection with your beer, further putting your competitors on notice of your trademark rights.

Even if you’re in the planning process, and have not begun selling your beer yet, you may apply on an “intent-to-use” basis, meaning that you have concrete plans to begin using your mark in connection with the sale of beer. An intent-to-use application allows you to claim priority over other companies who might begin using your mark or a confusingly similar mark in the period between your application date and the date you start actually using the mark.

Keep in mind that you may not be able to establish exclusive trademark rights in a mark that is generic or descriptive of your products. For example, if you’re selling an IPA called “Hoppy IPA,” you will likely be unable to stop other breweries from using the name “Hoppy” in connection with their hop-forward beers. The “Hoppy” mark would be deemed descriptive because it describes a characteristic of the beer. The only way to establish trademark rights in a descriptive mark is to show that consumers associate the mark with your company. In the “Hoppy IPA” example, that means that consumers who hear “Hoppy” would need to immediately connect that term with your brewery.

On the other hand, you can reference a characteristic of your beer with a suggestive mark that requires consumers to use some imagination to connect your mark to the product. For example, consider Deschutes’ “Fresh Squeezed” mark for their IPA brewed with Citra hops, which alludes to the citrus notes in their beer. Stronger still are arbitrary names that have no direct connection to your beer or its characteristics (think “Stone Brewing” or “Rogue Ales”) or fanciful names you made up that have no literal meaning (like “Mikkeller” or “CANarchy”).

Stay tuned for Part Two of our brewery-focused trademark posts, in which we will discuss considerations regarding coexistence agreements.

Conkle, Kremer and Engel has assisted its clients in securing and protecting their trademarks for over thirty years. Whether you’re in the planning stages or already operating your brewery, contact Zachary Page or CK&E’s intellectual property team for help identifying or protecting your trademarks.

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