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Luca CM Melchionna, Esq., Managing member Luca CM Melchionna has 25+ years of experience in both private practice and academia, in Italy and in the United States. He is a...
Luca CM Melchionna, Esq., Managing member Luca CM Melchionna has 25+ years of experience in both private practice and academia, in Italy and in the United States. He is a...
Mission Melchionna PLLC is an indipendent law firm. Melchionna PLLC’s mission is to provide outstanding legal services and tax advice. We focus on building a relationship with...
About us Melchionna PLLC represents and assists North American and European business clients in achieving their goals with sound legal advice and innovative solutions to current...
Since the 1930s, the Food and Drug Administration (“FDA”) has defined milk as “lacteal secretion [. . .] obtained by the complete milking of one or more healthy cows”. (21 CFR...
2019 Tax Protocol with Luxembourg On September 20, 2019, the US Treasury Department announced the ratification of a new tax protocol (“Additional Protocol”) between the United...
October 18, 2019, Update on “The United States is set to impose new tariffs on goods imported from certain countries of the European Union: the WTO DS316 Decision.” Cheese...
The increasingly globalized economy and income produced from digital media, combined with a renewed push for nationalism and protectionism, raises the issue of whether...
Based on the most recent US tariffs affecting European goods, Italian wines will not be subject to the new 25% tariff. However, Liqueurs and Cordials will be. This area is highly...
On 2 October, the Word Trade Organization (WTO) issued a decision (DS316 European Communities and certain Member States) authorizing the US to impose retaliatory tariffs on $7.5...
Wiring money internationally to clients, suppliers, and/or consultants may be a risky task for some businesses. The Financial Crimes Enforcement Network (“FinCEN”) reported...
This post follows up on an earlier post written about the same case. Tennessee law imposes a residency requirement on individuals (and companies) wishing to operate retail liquor...
On July 2nd, the United States Patent and Trademark Office (“USPTO”) announced a new rule requiring “all foreign-domiciled trademarked applicants, registrants, and parties to...
Social media advertising through “Influencers” is about to change. These personalities can bring in anywhere from $10,000 to $100,000 for each sponsored product recommendation or...
Since the 1930s, the Food and Drug Administration (“FDA”) has defined milk as “lacteal secretion [. . .] obtained by the complete milking of one or more healthy cows”. (21 CFR 133.3). Plant-based milks, however, enjoy no legal definition. Driven by robust consumer demand for dairy alternative products, sales of plant–based milks (like almond, cashew, soy or hazelnut milks) are expected to reach $20 billion by 2020 at the expense of real milk sales. In 2018 sales of actual milk plummeted by $ 1.1 billion (source Dairy Farmer of America 2018 http://www.dfamilk.com/newsroom/press-releases/dfa-reports-2018-financial-results).
Plant-based milk products supplanted actual milk with the use (and/or misuse) of the word “milk” and the addition of colorants. The FDA and judicial system avoided considering the merit of plant-based milk classification (or regulation) yet.
In Kelley v. WWF Operating Co, the plaintiff argued that plant-based beverages must be labeled “imitation milk because they are, in fact, nutritionally inferior to dairy milk”. (1:17-cv-117-LJO-BAM (E.D. Cal. 2017)), (Complaint, at 4). The Court held that this decision falls “squarely within the FDA’s authority, and will require the agency’s expertise in determining how to fashion labels so they adequately inform consumers”. Id. at 7; see also Am. Meat Inst. v. U.S. Dep’t of Ag., (496 F. Supp. 64, 646 F.2d 125 (4th Cir. 1981)).
In Painter v. Blue Diamond Growers, Painter claimed that “Blue Diamond Growers mislabeled its almond beverages as ‘almond milk’ when” California should have required them to label their product “imitation milk”. (No. 17-55901 (9th Cir. December 20, 2018) at 2). The US Court of Appeals established that the District Court properly dismissed Painter’s claim because “the Federal Food, Drug and Cosmetic Act (FDCA), contains a broad preemption provision, which prohibits a state from ‘directly or indirectly establish[ing]’ food labeling requirements ‘not identical to’ federal requirements.” (Id. at 2).
In Ang v. Whitewave Foods Co., the plaintiffs claimed that “defendants misbranded the [planted-based beverages] by using names like ‘soymilk,’ ‘almond milk,’ and ‘coconut milk,’ since the [plant-based beverages] are plant-based, and the FDA defines ‘milk’ as a substance coming from lactating cows”. (Case No. 13-cv-1953, (N.D. Cal. Dec. 10, 2013) at 2). The Court held that “these names clearly convey the basic nature and content of the beverages, while clearly distinguishing them from milk that is derived from dairy cows. Moreover, it is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow.” (Id. at 9-10). Accordingly, the District Court rejected the plaintiffs’ claim.
In Ocheesee Creamery LLC v. Putnam, the US Court of Appeals focused on whether “in using the term ‘skim milk’ the [commercial] speech is inherently misleading or merely potentially misleading.” (No. 16-12049, at. 16, F. Suppl. (N.D. Fla. 2017)). The US Court of Appeals referred to another case in its opinion, stating that “commercial speech does not merit First Amendment protection and may be regulated or even banned if (1) the speech concerns unlawful activity or (2) the speech is false or inherently misleading.” (Id. at. 10; see also See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 638, 105 S. Ct. 2265, 2275 (1985)). According to the holding, the plant-based commercial speech does not involve an unlawful activity, nor does it mislead consumers because use of the term “is merely a statement of objective fact.” (Id. at. 19). Thus, the commercial use of “skim milk” was sustained.
In addition to these court decisions, the Food Drug and Cosmetic Act (FDCA) prohibits states from imposing food identity requirements that do not concur with the FDA’s. As a result, the FDA is the sole authority to decide on such matters: a court can review a decision, if one is taken, but cannot order the agency to issue a decision. Since the agency has not yet rendered a decision on labeling plant-based milks, the judicial system is limited in its authority to respond more thoroughly to these complaints.
The European legal system, on the other hand, has taken a different stance towards plant-based milk labeling. On July 14, 2017, the European Court of Justice (ECJ) in Verband Sozialer Wettbewerb eV (VSW) v. TofuTown.com GmbH (Case C-422/16) stated that TofuTown’s promotion of pure plant-based products infringes on EU competition rules. The ECJ stated that, according to Article 78(2) and Annex VII, Part III, points 1 and 2, of EU Regulation No. 1308/2013, which regulates the market for agricultural products, TofuTown was not allowed to use the word milk for its plant-based products.
US and ECJ courts have taken opposite stances on the matter: the first reasoned that reasonable consumers can understand what they are buying, while the second holds regulators to a higher standard. In light of this comparison, what is the role of the FDA? Should the FDA be forced to make a decision on labeling plant-based imitation products?
The FDA finally appears to be taking action that seems likely to result in a change in the near future. On July 26, 2018, the FDA announced a comprehensive, multiyear FDA Nutrition Innovation Strategy, which is expected to modernize food identity standards in order to: “(1) protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics, and nutritional integrity of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods”,(source: FDA https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-horizontal-approaches-food-standards-identity-modernization-09272019-09272019). On September 27, 2019, FDA held a public meeting to begin this process. The deadline to submit written/electronic public comments is November 12, 2019.
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