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Avv. Flavia Betti Tonini, PhD, Of Counsel Flavia Betti Tonini is an experienced attorney with a solid background in corporate law, compliance, criminal law, and...

Posted on 13th January 2023 by lcmm@melchionnalaw.com

About us

Mission and Values

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...

Posted on 5th November 2019 by lcmm@melchionnalaw.com

About us

Melchionna PLLC, a law firm with a focus on business, corporate, tax, and IP law.

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...

Posted on 18th February 2019 by lcmm@melchionnalaw.com

Food law

Milk Sounding: How to reconcile legal definitions and consumers’ perception of products with potentially misleading labels: towards the modernization of food standard of identity

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...

Posted on 24th October 2019 by lcmm@melchionnalaw.com

Finance and banking

Bank Secrecy: US, Luxemburg, and Switzerland’s Governments have agreed to limit bank secrecy rule. The Additional Tax Protocol and Article 28 of the US-Luxembourg Tax Treaty

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...

Posted on 24th October 2019 by lcmm@melchionnalaw.com

International trade

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 imported from Italy

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...

Posted on 19th October 2019 by lcmm@melchionnalaw.com

International tax

A new Digital Service Tax in France soon to be followed by other countries: digital presence and tax sovereignties

The increasingly globalized economy and income produced from digital media, combined with a renewed push for nationalism and protectionism, raises the issue of whether...

Posted on 15th October 2019 by lcmm@melchionnalaw.com

Food law

October 10, 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.” Wines and Fortified (or Liqueur) wine

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...

Posted on 10th October 2019 by lcmm@melchionnalaw.com

Business law

The United States is set to impose new tariffs on goods imported from certain countries of the European Union: the WTO DS316 Decision

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...

Posted on 6th October 2019 by lcmm@melchionnalaw.com

Business law

Protect your money. Use two-step verification for wire transfers

Wiring money internationally to clients, suppliers, and/or consultants may be a risky task for some businesses. The Financial Crimes Enforcement Network (“FinCEN”) reported...

Posted on 6th August 2019 by lcmm@melchionnalaw.com

Food law

Update: Tennessee Wine and Spirits Retailers Association v. Thomas

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...

Posted on 11th July 2019 by lcmm@melchionnalaw.com

Trademark law

Trademark registration for foreign applicants is set to change on August 3rd

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...

Posted on 9th July 2019 by lcmm@melchionnalaw.com

Business law

The FTC takes aim at social media advertising

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...

Posted on 28th June 2019 by lcmm@melchionnalaw.com

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Food law

Milk Sounding: How to reconcile legal definitions and consumers’ perception of products with potentially misleading labels: towards the modernization of food standard of identity


lcmm@melchionnalaw.com
Milk Sounding: How to reconcile legal...
Posted on 24th October 2019 by lcmm@melchionnalaw.com

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.

The information provided here does not, and is not intended to, constitute legal advice but simply information for general purposes only and may not be the most up to date. Use of our website or any of its links or resources do not create an attorney-client relationship between the reader, user, or browser and the law firm. The views expressed at, or through, this site are those of the individual authors writing in their individual capacities only.

lcmm@melchionnalaw.com
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