- On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products. The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).
- MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
- The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings. It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
- Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
- Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
- Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.
- The comment period is open until January 13, 2024, and comments can be submitted through the docket.
Tag: food
Companies Gear Up For Mass Production of Cultured Meat
Could cultured meat be available in your U.S. grocery store in the new year? A previous article focused on the topic of “cultured meat” – meat made from the cells of animals and grown in a nutrient medium. While no cultured meat has yet been approved for sale in the U.S., companies are positioning themselves for mass production once needed approvals, licensing, inspections, etc., are obtained.
Earlier this month, Believer Meats broke ground on a $123 million plus facility in Wilson, North Carolina. The facility will be able to produce 10 metric tons of meat a year and will be the largest cultured meat facility in the world. The new facility will be Believer Meats’ second production facility. Last year it opened its first facility in Rehovot, Israel, with the capacity to make 500 kilograms of cultured meat a day. Believer Meats has developed processes to create cultured chicken, beef, pork, and lamb.
Investment in the cultured meat industry has been massive. For example, Believer Meats has $600 million in funding, and its investors include ADM Ventures, part of Archer-Daniels-Midland Co., and Tyson Foods.
Investment in the cultured meat industry has been massive.
So, with all of the investment and building of facilities, is the sale of cultured meat in the U.S. imminent? Cultured meat was first introduced in 2013. The eventual sale of cultured meat in the U.S. seems inevitable, but the timing is not yet clear. Before any cultured meat can be sold in the U.S., the FDA and USDA must approve the processes, license the facilities, inspect the facilities, inspect the meat, and approve labeling for the meat. Recognizing the rapid development of cultured meat products, the FDA established a premarket consultation process for companies to work with the FDA to start the process of regulatory approval for their cultured meat products. This premarket consultation process permits the companies to, voluntarily, work with the FDA, and to share information about their processes. The FDA premarket consultation does not, itself, “approve” the products, but evaluates the information shared by the companies – in order to determine if the meat is safe for human consumption. Specifically, as part of the premarket consultation, the FDA considers the cells used to make the cultured meat, the processes and materials used to create the cultured meat, and the manufacturing controls under which the cultured meat is created.
Recently, UPSIDE Food Inc. became the first cultured meat company to complete the FDA’s premarket consultation process. In November of this year, the FDA issued a No Questions letter to UPSIDE Food Inc. for its cultured chicken. The letter stated that information provided by UPSIDE Food Inc. to the FDA demonstrated that UPSIDE Food Inc.’s cultured chicken is safe and its production process prevents the introduction of contaminants that would adulterate the product. Last year, UPSIDE Food Inc opened a facility in Emeryville, California capable of producing 50,000 pounds of meat per year.
UPSIDE Food Inc.’s No Questions letter from the FDA is just the first step in the regulatory process. Pursuant to a 2019 agreement between the FDA and USDA, the FDA and the USDA will share oversight of the production of cultured meat. In addition to the premarket consultation, FDA will oversee the creation of the cultured meat up until the time of harvest, including licensing facilities, and inspecting the creation of the cultured meat. Inspections will ensure approved processes are being used and that the cultured cells are grown in a fashion that complies with Good Manufacturing Processes and food safety regulations.
When the cultured meat is harvested and processed into its final form, regulatory oversight will shift to the Food Safety Inspection Service (FSIS) of the USDA. As with traditional meat producers, cultured meat producers will have to apply for Grants of Inspection and be subject to similar inspections and food safety requirements. Labels for the cultured meat will also have to be preapproved by FSIS.
Before Believer Meats can sell any of its products manufactured in the North Carolina facility, Believer Meats will have to navigate the regulatory hurdles necessary to obtain approval of its products for sale to consumers. Believer Meats has indicated that it has been working with the FDA, but the FDA has not yet issued any statement on Believer Meats’ processes or products. However, with the start of construction on the world’s largest cultured meat facility, Believer Meats will be well-positioned to begin commercial production when regulatory approvals are obtained. We will be following this emerging new market and the regulatory rubric designed to oversee these cutting-edge food products.
Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.
FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims
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On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
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The claims were found on the 7 companies’ websites, social media pages, and/or Amazon or Walmart storefronts, and included a variety of statements regarding the products’ claimed abilities to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure). Six of the companies at issue sell a product(s) containing one or more dietary ingredients identified as Vitamin B3, red yeast rice, pine bark extract, EPA and DHA omega-3 fatty acids, magnesium, zinc, bergamot, Hawthorn berry, Hawthorn extract, Coleus forskohlii, hops, taurine, garlic powder, amino sulfonic acid, Co-Q-10, and/or octacosanol. The seventh company does not list a dietary ingredient but identifies its product as a “glycocalyx regenerating product” and notes various “pathologies associated with impaired endothelial glycocalyx.” As noted in the warning letters, FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. Further, in addition to characterizing the products as unapproved “new drugs,” FDA’s letters note misbranding charges based on the impossibility of writing adequate directions for a layperson to use the products safely for the intended purpose of treating one more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
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FDA requested that the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law. Failure to adequately address could result in legal action, such as product seizure and/or injunction.
For more Biotech, Food and Drug Law news, click here to visit the National Law Review
© 2022 Keller and Heckman LLP
Legal Considerations for Ready-to-Drink Cocktails
The ready-to-drink cocktail or “RTD” category has exploded in recent years, and it’s occupied by more than merely craft distillers familiar with a carefully made cocktail. Brewers, distillers and even vintners have joined in, capitalizing on consumers’ desires for pre-made, no-fuss beverages. The most unexpected development to emerge with RTDs, however, is the legal complexity surrounding these products—something the industry is only beginning to understand.
Many of these legal issues stem from the fact that the legal regulatory landscape in most states has not caught up with the rapidly evolving alcohol industry. That leaves ready-to-drink cocktails, much like hard seltzers, as not having a specific class or type in certain states. Suppliers looking to enter the space have plentiful options when creating a new product, subject to what licenses the manufacturer holds and what those licenses allow them to produce.
Ready-to-drink cocktails can be spirits, malt, sugar, cider or wine-based. The base of the RTD product, nonetheless, is the key federal factor. It is also an important factor in most states when determining how the product will be treated from a legal perspective in the following areas:
- Licensing needed to manufacture, distribute and sell the product;
- Applicable franchise law (Do beer franchise laws apply to low-proof spirits?);
- Available channels of distribution (Can you sell this product in grocery or convenience store?);
- Excise tax rate charged to the manufacturer (Does state law have a lower excise tax rate for low ABV products?);
- Labeling and advertising considerations (Is your product a modified traditional product?); and
- Trade practice considerations/promotions (Do spirits laws apply?).
Industry members dabbling in a sphere that is relatively new to the market, state regulators and legislatures should be mindful of the patchwork of emerging regulations. Like hard seltzer, ready-to-drink cocktails are not a clearly defined category under existing alcohol law. Meanwhile, states are working quickly to legislate in this domain. New Jersey is considering a reduced alcoholic beverage tax rate on low-ABV liquors to align with the beer tax rate (NJ SB 701), Vermont is considering legislation to define “low alcohol spirits beverage” and treat it as a “vinous beverage” (VT HB 590) and the Washington State Senate has a bill pending that would establish a tax on low-proof beverages (WA SB 5049).
From franchise issues to excise tax, the issues discussed here are only a glimpse of the nuanced and complicated legal landscape that governs the distribution of RTDs and alcoholic beverages across all categories.
© 2022 McDermott Will & Emery
Same As It Ever Was: FDA Reiterates That CBD Cannot Be Included in Food or Dietary Supplements
While we enter a new season this week, the same cannot be said for the FDA which, on November 16, reiterated that its approach to regulating the cannabidiol (CBD) industry will be “the same as it ever was”—a regulatory minefield. Grail Sipes, acting Deputy Center Director for Regulatory Policy at the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s position that it needs additional CBD research and safety data before the agency will consider CBD for uses beyond prescription drugs, including usage as a food additive or dietary supplement. This, she said, is because “clear answers to many important questions are still lacking, such as what adverse reactions may be associated with CBD from hemp-derived products and what risks are associated with the long term use of these products.”
So why should industry stakeholders care about the FDA’s opinion anyway? Wasn’t hemp-derived CBD legalized at the federal level by the Agriculture Improvement Act of 2018, also known as the Farm Bill?
Yes, but as we discussed in a previous blog post, the FDA and FTC have overlapping enforcement authority over CBD marketing, with the FDA having primary authority over labeling. The FDA has previously issued guidance stating that CBD can be used as an ingredient in cosmetics so long as it does not cause the product to be “adulterated or misbranded.” However, a product containing CBD cannot be marketed as a drug absent FDA approval—a lengthy and costly process. Companies marketing CBD products must therefore ensure compliance with the FDA’s labeling requirements and guidance regarding CBD products.
The FDA has not been shy to issue warning letters to CBD companies that fail to heed the agency’s labeling requirements and guidance. Starting in April 2019, the FDA (together with the FTC) began issuing warning letters to companies marketing CBD products as treatments and cures for a variety of diseases and illnesses. Those agencies continued to issue warning letters for marketing and labeling violations throughout 2019, largely for improper health-based claims about CBD products (those letters are described in more detail here and here). The most recent iteration came in 2021 when the agencies issued two warning letters to companies selling over-the-counter (OTC) drugs for pain relief that contained CBD. Sipes made clear the FDA will continue to monitor the CBD marketplace and issue warning letters to companies making improper health claims in her November 16 comments.
Given these comments, we can expect the cat-and-mouse game between federal regulators and CBD companies that push the marketing envelope to continue. To mitigate the risk of falling within the FDA’s crosshairs, CBD companies must ensure compliance with the various state and federal regulations governing the labeling and advertising of their products. We provided several marketing dos and don’ts in a previous blog post. But given the FDA’s unchanging position, the biggest takeaway remains the same: don’t make claims that a CBD product “can prevent, treat, or cure” or a disease.
Article By Rachel L. Sodée and J. Hunter Robinson of Bradley Arant Boult Cummings LLP
For more news on biotech, food, and drug law, click here to visit the National Law Review.
© 2021 Bradley Arant Boult Cummings LLP
Can the Government Really Shut Down My Business and Make Me Stay Home? Questions Answered Relating to Declarations of Emergency Due to Coronavirus
As companies face shutdowns and citizens are encouraged to stay home due to the coronavirus (COVID-19), businesses and people may be asking questions, such as can the government really do that? Those who followed China’s response to the outbreak—which involved using martial law to keep millions of citizens in their home—would have seen references in those stories western democracies being unable to use such extreme measures. Yet, it may now seem to some that our own democratic leaders are doing just that (and should be). Can they?
The short answer is yes, they can.
But fear not, because you are not likely to see tanks rolling down the streets enforcing martial law. There remain strong protections for citizens, even in times like these, preventing arbitrary government action. Unlike the famous Dunder Mifflin manager Michael Scott “declaring” bankruptcy in a building parking lot, when Governor Murphy declared a state of emergency in New Jersey he did not simply open the window of his office, shout “this is an emergency!” and then start issuing a list of edicts. His authority, and that of any executive, is restricted by the laws authorizing such a declaration.
A brief review from civics class:
To prevent abuse, the power to make laws, enforce laws, and interpret laws are separated into three branches, i.e., the legislative, executive, and judicial branches. That means the governor cannot simply do what he wants (like a king or dictator), even if he feels those actions are best for the people. He must do only those things which comply with the laws enacted by the legislature (as interpreted by judges). So upon declaring a state of emergency, Governor Murphy—and any other executive declaring an emergency—issued a series of executive orders invoking specific New Jersey legislative enactments. Those statutes pre-authorized the executive branch (which the Governor heads) to take certain, specific actions when the state is facing an emergency.
Most declarations of emergency in recent memory pertain to snowstorms or hurricanes. In those instances, the State invoked more familiar provisions of the statutes governing declarations of emergency, including freeing up money earmarked for emergency use; calling on the national guard to help with the effects of the storm; and allowing the police to redirect traffic. But the Governor’s statutory powers during an emergency are broad, flexible, and include the ability to “make such orders. . . as may be necessary adequately to meet the various problems presented by any emergency,” including “[t]he designation of vehicles and persons permitted to move during. . . emergency,” “[t]he conduct of the civilian population during the threat of and imminence of danger or any emergency,” and “[o]n any matter that may be necessary to protect the health, safety and welfare of the people. . . .” N.J. S.A. App. A:9-45. Violations of these orders are considered a disorderly person offense and may be punished by up to 6 months imprisonment, a $1,000 fine, or both.
In response to coronavirus questions:
Governor Murphy also invoked a provision of New Jersey law not implicated by other types of natural disaster called the “Emergency Health Powers Act,” which provided additional authorization for control over medical facilities, the distributions of medical resources, and authority to “identify areas that are or may be dangerous to the public health” and cause “movement of persons within that area to be restricted, if such action is reasonable and necessary to respond to the public health emergency.” N.J.S.A. § 26:13-9. The same law allows the State to “[r]equire the vaccination of persons as protection against infectious disease;” and although the vaccine cannot be “administered without obtaining the informed consent of the person to be vaccinated,” the state may require quarantine for “persons who are unable or unwilling to undergo vaccination. . . .” N.J.S.A. § 26:13-14. And the same law states that no public entity or its agents are “liable for an injury caused by any act or omission in connection with a public health emergency, or preparatory activities. . . .” N.J.S.A. § 26:13-19
So, can the government shut down your business and make you stay home?
Yes. And they can vaccinate you, quarantine you, and are immune from suit for doing any of those things.
There are, however, other avenues and considerations of which businesses and employees should be aware during these times. Many contracts contain force majeure clauses, which businesses should analyze to determine if they apply to coronavirus-related shutdowns, especially those mandated by the Governor’s recent executive order. Others may consider whether they have insurance coverage for a business interruption caused by the government-mandated shutdown. Employees and employers alike should keep abreast of the changing legal landscape surrounding paid sick leave.
©2020 Norris McLaughlin P.A., All Rights Reserved
For more governmental actions related to COVID-19 containment, see the National Law Review Coronavirus News section.
Proposed Class Action Lawsuit Claims Arizona Beverage’s Gummies are Not “All Natural” Because They Contain Synthetic Ingredients
On February 11, 2020, Christopher Silva, a New York resident, filed a proposed class action lawsuit against Hornell Brewing Co. Inc., Arizona Beverages USA LLC, Beverage Marketing USA, Inc., and Arizona Beverage Co. (“Defendants”) over defendants’ “all natural” gummy snacks.
The plaintiff claims that defendants’ advertising and marketing campaign is false, deceptive, and misleading because the gummies contain several synthetic ingredients, such as ascorbic acid, citric acid, gelatin, dextrose, glucose syrup, and modified food starch. Silva seeks to represent a New York class and individual classes for all 49 other states.
In the complaint, Silva cited to the United States Department of Agriculture’s Draft Guidance Decision Tree for Classification of Materials as Synthetic or Nonsynthetic (natural). Per that guidance, a substance is natural – as opposed to synthetic – if (a) it is manufactured, produced, or extracted from a natural source (i.e. naturally occurring mineral or biological matter); (b) it has not undergone a chemical change (i.e. a process whereby a substance is transformed into one or more other distinct substances) so that it is chemically or structurally different than how it naturally occurs in the source material; or (c) the chemical change was created by a naturally occurring biological process such as composting, fermentation, or enzymatic digestion or by heating or burning biological matter.
Silva noted that while the synthetic ingredients are all listed on the back of the package, reasonable consumers are not expected or required to review the ingredients list on the back in order to confirm or debunk defendants’ prominent front-of-the-product claims. The package in question includes the phrase “All Natural” on the packaging behind the words, “Arizona” and “fruit snacks.” We will continue to monitor any developments.
© 2020 Keller and Heckman LLP
For more on food ingredient labeling regulation see the National Law Review Biotech, Food and Drug law section.
Big Food Price-Fixing Update: Court Certifies Three Putative Classes in Packaged Seafood Litigation
What started out as a proposed merger between two of the largest packaged seafood manufacturers spawned a lengthy criminal investigation into antitrust violations in the tuna industry by the Department of Justice (DOJ) and multiple class and individual civil lawsuits. After four years of litigation, a major development in the class action lawsuits occurred– the Court certified three putative classes.
In 2015, the Department of Justice investigated a proposed merger between Thai Union Group P.C.L. (the parent company of Chicken of the Sea) and Bumble Bee Foods LLC. As the DOJ’s civil attorneys reviewed information related to the merger, they discovered materials that appeared to raise criminal concerns.[1]
Chicken of the Sea then “blew the whistle” to the DOJ regarding their anticompetitive conduct. This admission helped DOJ reach plea agreements with two other manufacturers, Bumble Bee[2] and Starkist,[3] as well as three packaged seafood executives—two from Bumble Bee[4],[5] and one from Starkist[6]. In connection with its guilty plea, Bumble Bee agreed to pay a $25 million fine, while Starkist’s fine is still pending. Bumble Bee’s CEO has also been indicted, and faces up to 10 years in a federal penitentiary. [7]
Now, the tuna manufacturers face a new challenge in the related civil actions. In 2015, on the heels of the DOJ investigation, three separate class actions were filed in the Southern District of California. Plaintiffs alleged that Defendants took part in various forms of anti-competitive conduct, including agreeing to fix certain net and list prices for packaged tuna. Plaintiffs alleged that the conspiracy began as early as November of 2010 and lasted until at least December 31, 2016.
On July 30, 2019, Judge Janis L. Sammartino granted the respective Motions for Class Certification filed by the Direct Purchaser Plaintiffs, as well as the two indirect classes–the Commercial Food Preparer Plaintiffs, and the End Payer Plaintiffs.[8] Judge Sammartino found that each class had satisfied Rule 23’s requirements and—contrary to the Defendants arguments—that common issues predominate over individualized issues within each class. For example, Plaintiffs contended that common evidence exists that would be used to prove the existence and scope of Defendants’ purported price fixing conspiracy.
The certification orders represent a major victory for each of the classes. They can now proceed to summary judgment and trial without any concern that their claims may be narrowed due to the mechanics of the proposed class. While dispositive motions are scheduled to be submitted later this month, no trial date is currently set. With certification rulings issued and merits briefing on the horizon, renewed settlement discussions are likely to come.
[2] https://www.justice.gov/opa/pr/bumble-bee-agrees-plead-guilty-price-fixing
[3] https://www.justice.gov/opa/pr/starkist-co-agrees-plead-guilty-price-fixing
[6] https://www.justice.gov/opa/pr/former-packaged-seafood-executive-pleads-guilty-price-fixing
[7] https://www.justice.gov/opa/pr/bumble-bee-ceo-indicted-price-fixing
[8] Case No.: 15-MD-2670 JLS (MDD) United States Court of Southern District of California
© 2019 Bilzin Sumberg Baena Price & Axelrod LLP
For more food industry news, see the Biotech, Food & Drug page on the National Law Review.
Big Food and Plant-Based Protein: Potential MEATing of the Minds?
Capitalizing on an increasingly health and environmentally conscious era, plant-based meat substitute companies are positioning themselves as the future of protein. On May 2, 2019, Beyond Meat became the first plant-based product company to go public. Its stock skyrocketed to become the highest performing first-day public offering in nearly two decades. Impossible Foods is also performing well. While the company is in no rush to go public, they just secured $300 million in their latest funding round.
In light of these recent successes, the meat industry is grappling with how to address the new food phenomenon. With the long-term viability of the alternative meat market yet to be seen, traditional meat companies are taking both an offensive and defensive approach.
Many Big Food companies view cell-based meat as an opportunity rather than a liability. Taking the “if you can’t beat ’em, join ’em” approach, these companies are integrating plant-based protein investments into their own portfolio. For example, Tyson was an early investor in Beyond Meat. Tyson recently sold its 6.52% stake in the company, but Tyson is still fully committed to competing in the plant-based protein space. Tyson announced that it plans to launch an “alternative protein product” with market testing as early as this summer. The fact that Tyson is a household name synonymous with meat could impede its ability to build brand loyalty in the alternative meat space. That said, the producer’s well-established distribution networks and manufacturing facilities will enable them to hit the ground running—an advantage that start-up companies in the emerging market necessarily lack.
Simultaneously, however, the meat industry is taking active measures to hedge against what, on its face, appears to be an impending threat of market erosion.
The meat industry is also lobbying for laws banning any non-slaughterhouse-derived protein product from being labeled “meat.” Last year, Missouri was the first state to formally do so. Lawmakers in 17 states—including Arkansas, Kentucky, Mississippi, North Dakota, South Dakota, and Wyoming—have followed suit. Laws in Montana, Georgia, Nebraska, and Oklahoma are also on the horizon.
Legislators and meat industry lobbyists are touting these laws as necessary consumer protection measures. Not surprisingly, proponents of plant-based meat disagree and are fighting back against legislation they say is aimed to protect cattle and livestock producers’ bottom line. Tofurkey, the Good Food Institute, the American Civil Liberties Union of Missouri, and the Animal Legal Defense Fund are challenging the Missouri law on constitutional grounds. Jessica Almy, director of policy for the Good Food Institute believes that the appeal should put other states on notice “that there are significant constitutional problems with these laws” because labeling is a form of “commercial speech, which is protected as long as it’s truthful.” The constitutional issue has yet to be resolved.
If Big Food is on board as a champion of plant-based protein rather than an opponent, the future for the protein industry certainly looks bright. But, it appears—at least for the time being—that meat alternative companies will have their work cut out for them as they navigate a newly developing (and often times conflicting) patchwork of state laws designed to stifle their marketing efforts. These uncertainties will continue to trigger disputes about what producers (that often operate in multiple states) can say about their products without misleading consumers, and just how far states can go to regulate commercial speech.
© 2019 Bilzin Sumberg Baena Price & Axelrod LLP
For more on the meat substitute industry see the National Law Review Biotech, Food & Drug page.
President Trump Signs the “Securing our Agriculture and Food Act”
President Trump recently signed the “Securing our Agriculture and Food Act” (H.R. 1238). The bill amends the Homeland Security Act of 2002 to direct the Assistant Secretary for Health Affairs for the Department of Homeland Security (DHS) to carry out a program to coordinate DHS efforts related to defending the food, agriculture and veterinary systems of the United States against terrorism and other high-consequence events that pose a high risk to homeland security.
According to Michigan Farm News, the law will:
- Provide oversight and management of DHS’s responsibilities pursuant to Homeland Security Presidential Directive 9 – Defense of United States Agriculture and Food;
- Provide oversight and integration of DHS activities related to veterinary public health, food defense and agricultural security;
- Lead DHS policy initiatives related to food, animal and agricultural incidents and to overall domestic preparedness for, and collective response to, agricultural terrorism;
- Coordinate with other DHS components on activities related to food and agriculture security and screening procedures for domestic and imported products; and
- Coordinate with appropriate federal departments and agencies.
This post was written by Aaron M. Phelps of Varnum LLP© 2017
For more legal analysis go to The National Law Review