PATRICK J. MCNAMARA, PARTNER
FEDERAL COURT IN NEW YORK THROWS OUT LAWSUIT CHALLENGING GRAS REGULATORY FRAMEWORK
For decades the GRAS process has been relied upon to promote flavor safety. More recently, in 1997, the FDA proposed the replacement of the affirmation process under GRAS for the notification procedure where any person can notify the FDA of a conclusion that a particular use of the substance is GRAS. In 2010 the Government Accounting Office issued a report that raised certain concerns about the proposed rule and made a series of recommendations to the FDA, including that the FDA seeks to minimize potential conflicts of interest in these determinations and require that a company conducts a GRAS determination to provide FDA with information such as the substances, identity and intended uses. The final GRAS rule was published on August 17, 2016. Under the final version of the GRAS rule, “any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of Section 409 of the Federal Food Drug & Cosmetic Act based upon that person’s conclusion that the substance is GRAS under the condition of its intended use”. The GRAS rule provides two ways for demonstrating status. The FDA still retains authority to take various actions including issuing warnings and stopping the distribution when a substance does not qualify for GRAS status.
In 2017 several plaintiffs, including The Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, The Environmental Defense Fund, and The Environmental Working Group filed an action in the U.S. District Court in the Southern District of New York alleging that the GRAS rule unlawfully subdelegates FDA’s duty to ensure food safety in violation of the U.S. Constitution the Federal Administrative Procedure Act and the Food Drug and Cosmetic Act. It also charged that it exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action in violation of the FDCA and the APA, and that it conflicts with the FDCA. In an opinion issued on September 30, 2021, Judge Vernon Broderick dismissed the lawsuit. He ruled that the GRAS rule is a lawful exercise of FDA’s authority under the FDCA and is not unconstitutional. In reaching this decision Judge Broderick applies the two-step analysis set forth in Chevron v. Natural Resources Defense Counsel to determine if FDA’s interpretation of the Food Drug and Cosmetic Act provisions governing GRAS substances was reasonable. The court ultimately concluded that the FDA’s determination that resources could be conserved by taking enforcement action after the fact, instead of requiring premarket approval, is reasonable in common place in the administrative process. To quote the Judge “In sum, I find FDA’s interpretation reasonable giving that GRAS substances are specifically exempted from the rigorous review applicable to food additives, GRAS submissions increased under the proposed GRAS rule, in more than sixty (60) years Congress has never required mandatory GRAS submissions, and the FDA has limited resources to allocate the food safety”. Judge Broderick also rejected the plaintiff’s argument that if GRAS notifications were mandatory, FDA could obtain all the information it needs to make food safety determinations if foreign ingredients are placed into food. While the Judge acknowledged that the FDA could require companies that conducted GRAS determination to provide the FDA with basic information, such as the substances identity and intended uses, the Judge noted that this is not the law. “I am cognizant of this reality, and the fact that circumstances have changed since the enactment of the food additives amendment. Still, this was recognized by FDA and the GAO, remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory. I decline plaintiff’s invitation to rewrite the statute. The remedy plaintiff seeks lies with Congress, not me, and Congress has chosen not to act despite the increase in a number of food additives over the last five (5) decades”.
Lastly, with the alleged concerns of conflict of interest, he saw no such issue and disagreed with the plaintiff’s assertions. The Court noted that in 2017 the FDA issued draft guidance on the issue, which is available on the FDA website entitled Best Practices for Convening a GRAS Panel Guidance for Industry. The Judge also noted that the FDCA is silent on what steps must be taking to address conflicts in GRAS determinations. He also noted that inherent in the GRAS rule are certain safeguards, including the GRAS notices much have the signed statement certifying that the notices are representative and balance submission that includes known and unknown and unfavorable information. As to the plaintiff’s contention that the Rule is contrary to the Delany clause, a provision within the FDCA that prohibits FDA from approving food additives that are found to cause cancer, the Court found that the GRAS process is not all unlawfully conflict with the FDCA.
POPPY SEED LITIGATION
Lawsuits involving poppy seeds are mounting across the country, as plaintiffs who have ingested unwashed poppy seeds are seeking to hold suppliers responsible for injuries and even death. According to several lawsuits, tea brewed with unwashed poppy seeds, which is touted to have medicinal value, could instead lead to Morphine and Cocaine overdoses. Seeds themselves possess no Opium content. However, the Opium alkaloids are found in the poppy latex which is a milky white fluid released from the pod when harvested. Depending on the methods used for harvesting unwashed poppy seeds may have higher amounts of Opium alkaloids, including but not limited to Morphine and Codeine on their seeds coats when compared to washed ones. Washed and processed poppy seeds are often used in foods to make pastries, cakes, and other bakery type products. Unwashed poppy seeds are widely available online. Last year Amazon and other defendants settled a lawsuit over the death of Steven Hacala, a 24-year-old resident of Arkansas who died of Morphine intoxication, alleging after consuming poppy seeds according to Bloomberg News. According to law.com several additional lawsuits are pending in one of our favorite states for product liability litigation, New Jersey. In a lawsuit that was originally filed in Utah and then transferred to New Jersey, the lawsuit alleges that 44-year-old Addy Kofford died from unwashed poppy seeds. An autopsy reveals she died of Morphine and Cocaine intoxication. The suit alleges claims of breach of warranty, negligence, and strict liability for the sale of the defective product. Two of the defendants in the case are New Jersey companies, JJ Nuts of Pompton Plains and Sincerely Nuts of Middlesex. The suit also alleges that Bracknell marketing of Tulsa, Oklahoma, doing businesses as Loan Goose Bakery, fraudulently transferred assets after learning of the lawsuits.
DIRTY HARRY WINS 6.1 MILLION LAWSUIT OVER UNAUTHORIZED USE OF HIS NAME AND PHOTO TO SELL CBD PRODUCTS
Clint Eastwood secured a $6.1-million-dollar default judgement against a Lithuanian company that falsely claimed that he endorsed a line of CBD gummies. Clint said that he was pleased with the Courts ruling and that the Judgement would send a powerful message to other online scammers who might try to illegally use someone’s name and likeness. In a statement issued by his attorney, “over a career that has been more the 60 years Mr. Eastwood has earned a reputation for honesty, hard work, integrity and public service”. He is also willing to do what is right and what is fair. In pursuing this case and obtaining this judgement Mr. Eastwood has again demonstrated the willingness to confront wrongdoing and hold accountable those who try to illegally profit off his name, likeness, and good will. A Federal Judge in Los Angeles awarded Eastwood and his company $6,940,000 in monetary damages. The Oscar winner initially sought an amount of $30 million, but the court lowered that number dramatically, leaving Eastwood to circle back with the lower figure that was approved by the Court. Judge Gary Klausner agreed that $6 million is what Eastwood reasonably would have charged the Lithuania based Mediatonas UAB to endorse a product for a 16-month online campaign, especially considering he rarely lends his image to commercial endeavors. The Judge noted that Mr. Eastwood’s name and likeness have only been licensed once for a single Superbowl commercial themed around America’s resilience and recovery from the Great Recession. In the litigation Eastwood claimed that Mediatonas owned a series of websites tied around ushealthynews.com and usmagazinetrending-news.com where it hosted its wholly fabricated articles about Mr. Eastwood to promote and sell CBD products. The fraudulent article had been included in the Court papers as an exhibit filed by Eastwood’s attorneys. There is no word yet as to whether the company will seek to appeal this ruling.
FOOD CHEMICAL SAFETY BILL
Recently the Food Chemical Reassessment Act of 2021 (FCRA) was introduced in Congress. Known as House Resolution 4694, representative Jan Schakowsky, Democrat from Illinois, and Chair of the House Energy and Commerce Subcommittee on consumer protection in commerce, said in a press release that he is proud to introduce the bill which would “require the FDA to consistently address chemicals that are added to our food. This will help FDA carry out its mission of protecting our public health and ensuring the safety of our nation’s food supply”. If enacted the bill would establish an office of food safety reassessment within the Center for Food Safety and Applied Nutrition in the FDA. The office would be tasked with studying the safety of at least ten (10) chemicals every three (3) years. According to Congressman Schakowsky, “there are thousands of chemicals added to food to make it last longer, taste better and look more enticing. Yet, most of these chemicals have never been reviewed by the FDA or were reviewed decades ago. He considers the GRAS process to be a loophole. After evaluating the chemicals, the office would then be required to issue regulations determining that any such substance or class of substance is safe within the meaning of Section 409 of the Federal Food Drug and Cosmetic Act and establishing new conditions of use if any under which any such substance or class of substances can be used safely for determining that any such substance or class of substances is unsafe. The legislation would also reestablish the food advisory committee who advises Secretary of Health and Human Services on the standards for reassessment, and the process and methods necessary to complete the work of the office. That committee was decommissioned several years ago due to budget restraints. Organizations including but not limited to The Environmental Working Group, Environmental Defense Fund, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend Our Health, and Earth Justice have all endorsed the Bill. As of this date there has been no companion legislation introduced in the U.S. Senate.
TRADEMARK TRIAL AND APPEAL BOARD UPHOLDS DENIAL OF APPLICATION TO THE US PATENT AND TRADEMARK OFFICE FOR CBD INFUSED TEA PRODUCTS
In a decision heard last summer and published on September 1, 2021, the U.S. Patent and Trademark Office trademark trial and appeal board upheld the decision by three (3) administrative trademark judges to deny this application, thus leading the company to appeal the decision, albeit unsuccessfully. In its appeal it stated that it had a “bonafide intent to use” its mark in the future because beneficial change to the laws around CBD is anticipated. In upholding the decision to refuse to register the trademark the board held that to qualify for Federal Trademark Registration, it has been consistently held that the use of a mark in commerce must be lawful, and that any goods which the trademark would be issued must not be illegal under Federal law. The decision noted that if the proposed mark or the identified goods of service are unlawful, the actual lawful use of the proposed trademark in commerce is not possible. Therefore, a refusal under the Trademark Act states the applicant does not have a bonafide use of mark in commerce justifies the denial.
CBD TRADEMARK CONTROVERSY
Trademark board noted that guidance giving after the inaugurate of the Agricultural Improvement act of 2018 commonly known as the Farm Bill, with regard to marketing attempt pending application was allowed to be refiled and a guidance document was issued entitled Examination Guide 1-19. Examination of marks for cannabis and cannabis related goods and services after 2018 Farm Bill, can be found at the U.S. Patent and Trademark Office website. In articulating the guidance, the TMEO stated that “such applications do not have a valid basis to support registration at the time of the filing because the goods violated Federal Law. The Examination Guide writes that the Farm Bill explicitly preserved FDA authority to regulate products containing cannabis or cannabis derived compounds under the Food Drug and Cosmetic Act, and CBD is an active ingredient in FDA approved drugs and is a substance undergoing clinical investigations. Therefore, the agency warns that foods & beverages containing CBD will still be refused since it may be unlawful under the FDCA, even if derived from hemp, as such goods may not be introduced lawfully into Interstate commerce. Here the applicant clearly intended to use the product to which CBD had been added. Because such goods are still illegal under the FDCA as a matter of law, the applicant could not make the lawful use of the market commerce and therefore was legally impossible for the applicant to have a bonafide attempt to use trade market in commerce. The appeal concluded that the refusal to register the applicants mark under Sections 1 and 45 in the Trademark Act is affirmed on the grounds that the applicant does not have a bonafide interest to use the mark in lawful commerce because the goods are not in compliance with the FDCA.
POTENTIAL CLASS ACTION LAWSUIT AGAINST COCO COLA’S GOLD PEAK TEA DISMISSED
A New York Judge just dismissed a punitive class action lawsuit against Coco Cola over labeling of Gold Peak Tea. The lawsuit, initially filed in February 2020 is one of the series of lawsuits that takes issue with terms such as “sort of sweet” “slightly sweet” “lightly sweetened”. The lawsuit brough by attorney Spencer Sheehan, who has also brought numerous lawsuits alleging various violations of state and federal law involving the use of vanilla. Coco Cola noted in its Court filings that the calorie count for the slightly sweet variant of Gold Peak Tea is listed prominently on the front of the packaging, on the back of the label plainly and accurately discloses the beverages sugar and calorie content. In an order dismissing the case in July 2021, U.S. District Judge Nelson Roman sided with Coco Cola, deciding that the plaintiff has not “plausibly alleged that slightly sweet on the product label will cause a reasonable consumer to assume that is quote “low sugar, and lesser in calories”. The allegation of misleading consumers is taking a variant of the fact that the FDA has not yet defined “low sugar” and so there is no legal definition of terms such as “sort of sweet”, “slightly sweet”, “just a tad sweet” or “lightly sweetened”. Another case against General Mills was also dismissed in a different lawsuit where the Court again found that consumers could not plausibly claim to be misled about sugar content of the cereal products because the defendants provided them with all the required objective facts about its products on both the side panel and the front of the product labeling.
CAULIFLOWER OUTER AISLE GOURMET VS. BIMBOS BAKERIES
This lawsuit alleges unfair competition under the Lanham Act, and seeks judgement for trademark infringement and the cancellation of Bimbo Bakeries sandwich thins trademark. It acknowledged that the subsidiary of Bimbo known as Arnold Sales Company, acquired by Bimbo in 2009, had been selling a wheat base sandwich thin product for some years and secured a registered trademark for sandwich thins back in 2009. Outer Aisle is trying to argue that Bimbos “failed to police” the trademark over the years and that Bimbo had effectively abandoned its rights to the trademark which would allow Outer Aisle to use its product. Last March Outer Aisle was advised by Amazon that its cauliflower sandwich thins had been delisted, following complaints by Bimbo accusing Outer Aisle of trademark infringement. In early 2021, as Bimbo Bakeries released its own “veggie” sandwich thins under the Oroweat brand on its website it filed a new trademark application for cauliflower infused sandwich thins and filed an online complaint with Amazon accusing Outer Aisle of infringing its intellectual property. This lawsuit, filed last March, also accuses Bimbo of unfair competition. Outer Aisle said it is losing money daily as result of Bimbo’s “hard ball tactics”. In an amended complaint Outer Aisle said Bimbo “cannot have experienced any trademark infringement, benchmark of which is consumer confusion, because their competing product is not in commerce yet and it is not yet being sold on Amazon”. It is quoted in an article published by foodnavigator-usa.com in October, the founder of Outer Aisle claimed this is a classic “David v. Goliath” type of case where they contend the legal action is necessary to address Bimbo’s business tactics. Bimbos Bakeries has filed a motion to dismiss, arguing that the company has full common law rights to use the term sandwich thins and that Outer Aisle arguments that it has such rights were considered “non-sensible” by Bimbo.
BIDEN ADMINISTRATION EXPECTED TO NAME DOCTOR ROBERT CALIFF AS THE NEW COMMISSIONER OF THE FDA
If nominated, Dr. Califf will fill a position currently occupied by acting commissioner Dr. Janet Woodcock, MD. Dr. Califf lead the agency from February 2016 to the end of the Obama Administration after serving a year as the agencies Deputy Commissioner for medical products and tobacco, according to the FDA website. He was succeeded as commissioner by Dr. Scott Gaverly. Dr. Califf received his MD at Duke University Medical School and served as a professor of Cardiology there. He founded and directed the Duke Clinical Research Institute at the school at the time he was nominated to lead FDA back in 2016.
FDA ANNOUNCES NEW VOLUNTARY SODIUM REDUCTION GOALS
On October 14, 2021 notice was published in the Federal Register by the FDA announcing the availability of the final guidance document for industry entitled “Voluntary Sodium Reduction Goals; target mean an upper bound concentration for sodium and commercially processed package and prepared food”. The notice is found at page 57156 of the October 14 federal register. The guidance document describes the agencies used the voluntary short term “2.5 years” for sodium reduction in variety of products. Comments can be submitted either electronically or by written/paper submission. The guidance documents can also be obtained as hard copy through the Center for Food Safety and Applied Nutrition in College Park, Maryland. The guidance represents current thinking of FDA on this topic and does not establish any rights for any person as consider non-binding on FDA. This is a follow-up document on the one issued in June of 2016 by the FDA. The guidance document is intended to support an average sodium intake reduction to 3,000mg per day. Instructions for submitting comments can also be done through www.regulations.gov. Advocacy groups like the Center for Science in the Public Interest urge the FDA to move forward with a more ambitious long term ten (10) year target for sodium reduction.
BABY FOODS AND SAFETY
Following the introduction of baby foods safety act in congress, as well as a series of lawsuits being filed against baby food brands that were named in the Courts have been issued by certain members of congress, the FDA is unveiling a new action plan called “closer to zero- “which is going to set forth this approach through analysis of exposure to toxic elements found in commonly eaten foods by babies and young children. Back in March Food Navigator USA.com reported that as of that date at last forty-three (43) lawsuits had been filed alleging heavy metal or toxic metal contamination in baby food. The companies that were named in the report issued by Congress last February, such as Gerber, Beechnut Nutrition, Campbell Soup (from organics, nurture inc.), Happy Family Organics, Hain’s Celestial, Sprout Foods Inc, and Walmart have been hit with lawsuits in various federal courts. There are those who questioned the science behind these reports, but it has not slowed down the lawsuits that are being filed. Under the “close to zero” action plan, the FDA will evaluate scientific basis for setting limits on heavy metals starting with arsenic and lead and propose limits based on that review. It will then conduct similar reviews for cadmium, and mercury, and propose limits for both. Industry groups welcome the plan, addressing that having federal standards regarding these elements should be evaluated by FDA and guided by science.
JUUL, ALTRIA & WAWA SUED IN FEDERAL COURT OVER VAPOR DEVICES AND FLAVORED PODS
On August 24th a lawsuit was filed in the U.S. District Court in the State of New Jersey against JULL, Altria Group, Philip Morris, and other companies, including retailers such as Wawa, alleging that the Plaintiff suffered serious physical injuries including lung damage as a result of using JUUL and Vaporesso devises and flavored JUUL pods. The Complaint which runs nearly 100 pages, filed by the law firm Weitz and Luxenberg, who are well-known Plaintiffs personal injury attorneys. They allege that the efforts by the defendants were designed to “addict a new generation of teenagers and young adults to nicotine in a wrongful conduct and marketing, promoting, manufacturing, designing and selling JUUL substantially contributed to plaintiff’s injuries.” They allege that the JUUL device heats a nicotine filled liquid JUUL pod, which is sold separately in “fun favors like mango and cool mint”, in what the complaint alleges was a “powerfully potent dose of nicotine, along with aerosol and other toxic chemicals into the lungs, body and brain”. The complaint alleges that the plaintiff became highly addicted to JUUL and would crave nicotine, particularly from flavored products as she had become accustomed to from use of JUUL products. This addiction led plaintiff to purchase and use Vaporesso, a refillable e-cigarette device. The complaint alleges that the plaintiff’s nicotine addiction “worsened after switching from cigarettes to JUUL and Vaporesso because of the high nicotine delivery of these devices and due to their design, which allowed ease of use throughout the day.” The complaint alleges that the plaintiff “was unaware that the use of JUUL and Vaporesso could cause severe lung injuries resulting in trauma, long term pulmonary problems and other injuries.” Moreover, plaintiff was unaware how much nicotine a JUUL pod contained or delivered. The complaint goes on to allege that JUUL and the e-liquid manufactures, developed flavored JUUL products that would appeal to youth and contain toxic ingredients. The complaint also alleges that the defendants designed their e-cigarettes to make them easy to inhale and to deliver substantially higher doses of nicotine then cigarettes. The complaint also alleges that the amount of nicotine in each JUUL pod is “intentionally misrepresented and grossly understated”. The complaint also alleges that the plaintiff “was never warned that JUUL products were unsafe and dangerous”. The complaint also goes on to raise questions as to the virtual marking campaign and online marking engaged in by the defendants. Included in the complaint are various photographs illustrating the type of media campaign that is complained about in the pleading. It noted that free products were even given away at various social events as part of the marketing plan. The causes of action asserted in the complaint are as follows: Count One is strict liability and alleged design defect, Count Two argues there is violation of New Jersey strict liability law in failure to warn the plaintiff of dangerous and defective and unsafe product, Count Three alleges a product liability manufacturing defect asserting strict liability, Count Four alleges violations of New Jersey’s consumer fraud act, N.J.S.A. 56:8-2 et seq., Count Five alleges breach of express warranty, Count Six seeks punitive damages under New Jersey Statute 2A:15-5.11 et seq., together with interest, cost of suit and legal fees and such other relief as the court may deem appropriate. Plaintiff also asked for a tolling of time to defend against any claims that the action has been brought too late and thus is barred by New Jersey Statute of Limitations.
The FDA is also concerned about the use of these products by teenagers. Noted that the day to day of assemble suggest that both youth and young adults would use these systems begin with flavor such as fruit cand or mint and not tobacco flavors. This data reinforces the FDA decision in its words “to authorize a tobacco flavored product because these products are less appealing to youth and authorizing these products may be beneficial to adult cigarette users who switch over to these systems or significantly reduce their cigarette consumption.
The FDA authorization also imposes strict marketing retractions on a company, including digital advertising restrictions as well as radio and tv advertising to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA will continue to issue decisions on applications as appropriate, and that they are committed to working to transition the current marketplace to one in which all electronic nicotine delivery systems (ENDS) products available for sale had demonstrated that marketing the product is appropriate for the protection of public health. The FDA of course did state that al tobacco products are considered harmful and addictive and those who do not use them should not start. Then the FDA noted that it “may suspend or withdrawal marketing order issued under regulatory authority for a variety of reasons if the agency determines to continue marketing the product is no appropriate for the protection of public health, especially if there is a significant increase in youth consumption”. The FDA is aware that the survey done this year of youth consumption of tobacco found approximately 10% of high school students who currently use the e-cigarettes named JUUL as a favored brand. The FDA takes this data very seriously and considered risk to youth when previewing these products. The announcement that the evidence also indicated that, compared to users with non-tobacco flavored ENDS products, teenagers are less likely to start using these products and then switch to higher risk products such as combustible cigarettes.
LITIGATION OVER ALLEGED MISLABELING OF SELTZER WATER
In an article published last month in the New Jersey law Journal it was noted that litigation over the labeling of Seltzer Water is becoming one of the latest battle grounds in food product labeling litigation. Manufacturers of these fruit flavored seltzer and sparkling water products are being accused in various lawsuits of misleading consumers with labeling that falsely suggests the products contain more than the minimal amount of real fruit. Some of the lawsuits being filed also claim that the product labeling of Agave or Pineapple flavor falsely suggest that the product contains ingredients rather than actual flavors.
Over the last eighteen months suits have been filed against makers from everything from Coca Cola to Cake mix and Almond milk claiming that consumers are misled by labels using the term vanilla even though no vanilla beans are used their production. Many of these lawsuits, however, have been thrown out at the motion to dismiss stage of the case. The theories behind the Seltzer and vanilla cases are somewhat similar. These types of theories that failed in some of these vanilla cases are now basically being parroted in these cases against the sparkling water manufacturers. A report issued from a national law firm reports that 220 food and beverage class actions were filed nationwide in the year 2020, which is up from only 45 in the year 2010 and 158 in the year 2015. New York is the busiest state for class actions over food marketing, passing California in 2019 according to this report. In 2020 107 food mark and class action suits were filed in New York and 58 more in California. The lawsuits often rely primarily on state laws for consumer protection as the bases for the litigation. In the Seltzer cases the applicable standard is generally whether a reasonable person would think that they are being ripped off. Courts have had already been forced to decide whether consumers would tend to think that seltzer labeled as fruit flavor contains flavor divided from the fruit rather than artificial flavors. The increase in the New York suits is being contributed in large part by activities Spencer Sheehan in Great Neck, New York you’ve probably heard his name before because he has brought many of the vanilla litigation cases in New York as well, including the Wholefoods sparkling water lawsuit. Sheehan, however, has not publicly stated why the Wholefoods case was dismissed last August on a voluntary basis. Sheehan has also brought various lawsuits claiming that graham cracker falsely claimed to contain a special type of flour and that gouda cheese is not really smoked. He acknowledged in a recent legal publication that he files these lawsuits prompt manufactures to do better jobs of improving the content of their labeling in a “clear and forthright manner”. Acknowledging that many of the lawsuits he brought over vanilla flavoring had been dismissed, Sheehan stated that “it doesn’t mean I’m going to stop bringing cases”.
CALIFORNIA GOVERNOR SIGNS LAW LEGALIZING SALE OF FOOD AND BEVERAGES CONTAINING HEMP DERIVED CBD
Last month Governor Newsom signed Assembly Bill 45 explicitly legalizing the sale of foods beverages and supplements containing hemp derived CBD. The new law resolves an impasse that began three years ago when California regulatory bodies aligned themselves with the FDA’s position that CBD is not a legal dietary ingredient as it was first investigated as a drug. According to the new law nonintoxicating hemp derived extracts such as CBD are explicitly permitted for sale as dietary supplements and food and beverage ingredients. The law allows intoxicating cannabis products to be hemp. They must be sold to adult use cannabis channels only. The law says that hemp related products cannot contain more the 0.3% THC. That is defined in California Law Department of Public Health. It also must be tested in raw extract final form before being incorporated into a product by an independent testing lab and must not exceed 0.3% total THC. It also must be tested for any types of contaminants. The law also requires that product labels must be through a barcode website or QR code linked to the certification that analysis the final form product batch by an independent testing lab, and must reference among other things, the concentration of cannabinoids present in the batch. Again, the states are finding themselves passing laws that are remaining contrary to law at the federal level.
MARS ANNOUNCES INITIATIVE TO ACHIEVE ZERO EMISSIONS BY 2050
In early October Mars issued a document outlining the process it intends to follow to reach net zero admissions across its entire business enterprise by the year 2050. Chief Executive Grant Reid insisted that long-term goals cannot be an excuse for “inaction and delay”. Mars has set new science-based climate targets to achieve zero greenhouse gas admissions across its entire business chain by the year 2050. This covers everything from agriculture through missions generated by consumers using its household products. The company first sets its carbon reduction targets back in 2009 when it said it would achieve zero net and direct admissions by the year 2040. Previously announced targets to reduce its global greenhouse gas admissions for the full value of its business by 27% by the year 2025 and by 67% by the year 2050, when compared to 2015 levels. Mars announced that is has reduced admissions across the board by 31% and is on track to achieve its interim targets by 2025. Mars is also working to transition towards renewable energy sources. The company announced that it now sources 100% renewable electricity for its operations in 11 countries accounting for more than 54% of its global electric demand, with the plan to switch over in another 8 countries by the year 2025. To quote from CEO Grant Reid, “the scale of global innovation must be bolder and faster. Climate change is only impacting the planet and people’s lives. The science tells us net zero targets must be brought in their reach, capturing admission across the entire value chain and plants need that material to meet targets. We can’t wait decades to see progress”. Mars also announced that its largest brand, pet nutrition brand Royal Canin will pursue carbon neutrality its full portfolio.
Barry Parkin, whose serves as the chief sustainability and procurement officer for Mars, was quoted in his response to the need for action throughout the supply chain “our impacts are embedded in the materials that we purchase, so we must change what we buy or where we buy it or perhaps more importantly how we buy it”. Mars is also increasing engagement with its agricultural suppliers to scale up initiatives in sustainable and regenerative practices. Mars sees the need to use carbon credits since certain areas of its industrial business may not be able to get to zero, especially when it comes to agricultural emissions. The report stated that “our road map to net zero clearly prioritizes our own emissions that there is a recognition within the science community that the agricultural sector will be particularly hard to complete decarbonization. Therefore, carbon removal credits will have to play a part in helping us to neutralize any remaining emissions. In during this, we will apply a high level of rigorous in any credits we buy are removing carbon from the atmosphere and that its track strong science and monitoring.
FEDERAL JUDGE IN UTAH ISSUES CONSENT DECREE STOPPING DIETARY SUPPLEMENT MANUFACTURER FROM SELLING MISLABELED PRODUCTS
The U.S. District Court for the District of Utah has entered a constant decree of preliminary injection between the federal government and Grandmas’ Herbs Inc. of St. George, Utah, and its owners. The company was accused by the FDA of manufacturing and distributing products which it marketed as dietary supplements with labeling that rendered them unapproved new drugs and/or misbranded drugs. The FDA had not approved the company’s products for any use, despite the company’s claims its products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy. The consent decree expressly prohibits the defendants from directly or indirectly manufacturing and distributing such project products until certain regulatory requirements have been met to FDA’s satisfaction. In a press release announcing the entry of the consent order the agency said, “the FDA’s action is aimed at protecting consumers who are unknowingly putting their health at risk by using products with claims to cure, treat or prevent a serious illness. We urge consumers to seek proven treatments recommended by licensed healthcare professionals”. The company had been previously issued a warning letter by FDA in 2017, informing the company that many of the products being sold through its website are not dietary supplements as they were being marketed, instead as unapproved new or misbranded drugs because they were intended to cure, mitigate, treat, or prevent disease. The consent decree prohibits the company from marketing such products until, among other things it retains the services of a labeling expert; removes its products and replaces the labeling and receives written permission form the FDA to resume operations.
FDA WARNING ON MISLABELING OF DIETARY SUPPLEMENTS
The FDA has issued a warning notice to company called ICL Health, LLC based in Tucson, Arizona. The company markets several dietary supplements. The warning letter claims that the company is making unprovable claims to treat a host of conditions, including but not limited to all auto immune diseases, fibromyalgia, alcoholism, rheumatoid arthritis, and depression. The warning letter resulted from a review of the company’s various websites and not a physical inspection. The FDA is awaiting a response letter from the company.
NEW USDA INITIATIVE TO COMBAT SALMONELLA
On October 19 the Food Safety and Inspection Service announced that is mobilizing “a stronger and more comprehensive effort” to reduce salmonella illnesses that are associated with poultry. This is part of an effort to reach a national target of the 25% reduction in salmonella illnesses. The agency noted that more than one million consumer illnesses due to salmonella occur annually, and that they estimate that close to 25% of these illnesses are due to consumption of contaminated chicken or turkey. The agency stated that a key component of this approach “is encouraging use of preharvest controls to reduce salmonella contamination coming into the slaughterhouse”. The agency acknowledges that reducing manilla infections attributable to poultry is one of their top priorities. They also acknowledge that over time it has been shown that their current policies are not moving American society closer to the public health goal. It is the intent to take the data generated from these piles of programs regarding poultry slaughtering and processing establishments to be used to determining if a different approach would result in a reduction of salmonella illness in consumers. The agency also acknowledge that this initiative is going to require collaboration in an ongoing dialog with steak holders, industry representative, consumer groups and researchers.