Nicolas Dahan, Seton Hall University and Bernard Leca, ESSEC

About 19 million children under 5 around the world suffer from severe acute malnutrition every year. This life-threatening condition kills 400,000 of them – that’s one child every 10 seconds.

These numbers are staggering, especially because a lifesaving treatment has existed for nearly three decades: “ready-to-use therapeutic food.”

Nutriset, a French company, was founded by Michel Lescanne. He was one of two scientists who invented this product in 1996. A sticky peanut butter paste branded Plumpy’nut, it’s enriched with vitamins and minerals and comes in packets that require no refrigeration or preparation.

Health care professionals were quickly convinced of its promise. What was harder to figure out was how to manufacture as many packets as possible while cutting costs. In 2008, ready-to-use therapeutic food producers like Nutriset charged US$60 for one box of 150 packets – the number needed to treat one severely malnourished child for the 6-8 weeks needed for their recovery.

In a study we published in the Journal of Management Studies in October 2024, we explained how the international agencies, nongovernmental organizations, activists and for-profit companies involved in the product’s distribution managed to resolve a public controversy over the use of Nutriset’s patent and its for-profit business model.

Contrary to the expectations of activists and many humanitarian NGOs, this for-profit company managed to reduce its prices down to $39 per box of Plumpy’nut packets by 2019 and keep them consistently lower than any nonprofit or for-profit competitors could, all the while enforcing its patent rights.

We interviewed Jan Komrska, a pharmacist then serving as the ready-to-use therapeutic food procurement manager at UNICEF, the United Nations agency for children; Tiddo von Schoen-Angerer, a pediatrician who was leading the access to medicines campaign at Doctors Without Borders, a medical charity; and Thomas Couaillet, a Nutriset executive. We also studied documents issued over the course of a decade to find out why this company’s unusual approach to intellectual property protection was so successful.

Helping franchisees in low-income countries get started

Nutriset and humanitarian organizations disagreed at the start over how to proceed with the production of ready-to-use therapeutic food.

Doctors Without Borders at first accused Nutriset of behaving like a big drugmaker, shielding itself from competition by aggressively enforcing its patents to charge excessively high prices. The nongovernmental organization demanded that Nutriset allow any manufacturer to make its patented packets, without any compensation for that intellectual property.

By 2012, Nutriset had changed course. It had stopped being almost the sole producer of ready-to-use therapeutic food and instead allowed licensees and franchisee partners, chiefly located in low-income countries, to make the packets without having to pay any royalties. It did, however, make an exception for the United States. It allowed Edesia, a Rhode Island-based nonprofit, to become a Nutriset franchisee.

It also provided these smaller producers with seed funding and technical advice.

Nutriset is still the world’s largest ready-to-use therapeutic food producer, we have determined through our research. It’s responsible for about 30% to 40% of the world’s annual production, down from more than 90% in 2008.

There are some other U.S. manufacturers, such as Tabatchnick Fine Foods, but they aren’t Nutriset partners.

Threatening legal action

At the same time, the company continued to threaten to take legal action against potential rivals located in developed countries that were replicating their recipe without authorization. Usually, cease-and-desist letters were sufficient.

Nutriset implemented this strategy to ward off competition from big multinational corporations that might try to establish their brands in new markets, gaining a foothold before flooding them with imported ultraprocessed food. A big risk, had that occurred, would have been less breastfeeding for newborns and the disruption of local diets.

Nutriset’s strategy of opening access to its patent selectively has enabled UNICEF to double the share of packets it buys from producers located in the Global South.

UNICEF, the world’s biggest buyer of ready-to-use therapeutic food, bought less than one-third of its supplies from those nations in 2011. That share climbed to two-thirds in 2022.

Nutriset’s reliance on local franchisees has helped create over 1,000 jobs in hunger-stricken regions while strengthening the supply chain and reducing the carbon emissions of transportation, according to UNICEF.

Nutriset’s creative patent strategy also helped its partner producers in low-income countries, which include nonprofit and for-profit ventures, compete with large corporations in developed countries by the time its patent expired in 2018.

In this instance, a for-profit company not only managed to keep its prices lower than its competitors, including nonprofits, but used its patent to support economic development in developing countries by shielding startup producers from international competition.

As a result of these successes, we found that nongovernmental organizations eventually stopped criticizing the French company and recognized that high prices were actually not due to Nutriset’s patent policy but rather to global prices of the packets’ ingredients.

In recognition of its contributions and innovation, Nutriset won the U.S. Patent and Trademark Office’s Patents for Humanity Award in 2015.

Offering a cheap, convenient and effective treatment

One of the biggest advantages of ready-to-use therapeutic food is that parents or other caregivers can give it to their kids at home or on the go. That’s more convenient and cheaper than the alternative: several months of hospitalization where children receive a nutrient-dense liquid called “therapeutic milk.”

The at-home treatment works most of the time. More than 80% of the children who get three daily food packets recover within two months.

Severe acute malnutrition deaths remain high because historically only 25% to 50% of children suffering from it get treated with ready-to-use therapeutic food, due to insufficient funding. The treatment programs are run by governments, UNICEF and other international agencies, and NGOs such as Doctors Without Borders.

USAID’s funding role

The U.S. government spent about $200 million in 2024 through the U.S. Agency for International Development on ready-to-use therapeutic food, enough packets to treat 3.9 million children. That’s nearly as much as UNICEF, which treats about 5 million children annually.

It’s unclear whether the Trump administration, which is trying to dismantle USAID, will discontinue its funding of ready-to-use therapeutic food that the U.S. government has purchased exclusively from U.S. manufacturers with U.S.-sourced ingredients.

At a time when the flow of development aid from several wealthy countries is declining, the precedent Nutriset set suggests that humanitarian organizations, by teaming up with international agencies, governments and for-profit companies, can help drive down the costs of saving lives threatened by hunger while increasing the nutritional autonomy of the Global South.

But the funding for ready-to-use therapeutic food and its distribution has to come from somewhere, whether it is from governments, foundations or other donors.

Nicolas Dahan, Professor of Management, Seton Hall University and Bernard Leca, Professeur en sciences de gestion, ESSEC

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Katharine Neill Harris, Rice University

In Texas, where I live, marijuana has long been illegal. Yet on a busy street in my Houston neighborhood, at least five stores within a half-mile of each other sell cannabis products that promise a strong high.

Texas isn’t alone. Due to a mix of recent legal changes and an uncertain policy landscape, residents in roughly half of American states have easy access to impairing hemp products that bear a strong resemblance to marijuana and are far less regulated.

As hemp sales soar – reaching nearly US$3 billion in 2023 – a number of states are tightening their restrictions, while experts are analyzing the public health implications. That’s why I analyzed hemp policies in all 50 states with some of my colleagues at Rice University’s Baker Institute, where I’m a drug policy fellow.

Marijuana and hemp: Same plant, different policies

Marijuana and hemp are both varieties of cannabis sativa, a plant with many uses that produces thousands of compounds. Among them is the popular intoxicant delta-9 tetrahydrocannabinol, or delta-9 THC.

Hemp is widely valued as an industrial crop, and for most of American history, farmers freely cultivated it. But by the mid-20th century, lawmakers had grown increasingly opposed to marijuana and were concerned by hemp’s similarity to its impairment-causing cousin.

In an effort to permit hemp cultivation while prohibiting production of a psychoactive plant, the Agricultural Marketing Act of 1946 defined hemp as all parts of the cannabis plant with less than 0.3 percent concentration of delta-9 THC by dry weight. Cannabis that exceeded this threshold was considered marijuana.

The 1970 Controlled Substances Act ushered in the modern era of prohibition of marijuana and other drugs. Hemp remained technically legal, but because of its similarity to marijuana, it was listed as a Schedule I drug, alongside heroin and other substances deemed to have a high potential for abuse and no medical value.

Because of hemp’s Schedule I status, the Drug Enforcement Administration tightly regulated its production. But hemp farmers have long argued that these regulations were excessive – and in 2018, Congress agreed. That year, lawmakers passed a farm bill that removed hemp from the Controlled Substances Act and legalized the manufacture and sale of hemp and its derivatives.

Crucially, the 2018 bill still defines hemp as all parts of the plant and its derivatives that have less than 0.3 percent delta-9 THC. But it left a loophole: While delta-9 is the most well-known form of THC, it’s not the only one. Other forms of THC, known as THC isomers, have similar effects. These isomers, like delta-8 and delta-10 THC, can be derived from the hemp plant, and like delta-9 THC, they can cause impairment. The 2018 Farm Bill legalized all of them.

In 2023, sales of hemp-derived cannabinoids reached US$2.8 billion. Market growth has been accompanied by a rise in adverse health events. Chemists have expressed alarm at how some hemp products are made, and analyses of commercially available products have found them to contain heavy metals, residual solvents and pesticides.

Given the lax regulatory environment, many public officials now question the lack of guardrails on this burgeoning hemp industry. As a result, officials and governments across the country are now enacting or considering policy changes.

Some states are imposing age and advertising restrictions

In 2023, 11.4% of 12th graders said they had used hemp-derived delta-8 THC in the past year. Easy access to any substance can encourage use, and THC can have negative impacts on the adolescent brain.

While federal law prohibits the sale of tobacco and alcohol to individuals under 21, there is no similar national requirement for hemp. But at least 27 states that permit the sale of hemp-derived products now have minimum age requirements, and several others have pending legislation.

Lessons from the tobacco market also demonstrate that advertising restrictions can reduce the use of legal but potentially harmful products. Most efforts to curtail hemp advertising focus on youth. Sixteen states restrict the use of packaging and marketing materials that may appeal to minors. Meanwhile, federal regulations also limit youth-targeted marketing.

There are fewer restrictions on advertising to adults. The Food and Drug Administration does prohibit using unverified health claims to sell hemp products, but this standard gives the industry plenty of leeway. Hemp ads often tout their purported physical benefits, like reducing pain or improving sleep, or portray them as mood-boosters that can make one feel euphoric and aroused, with few downsides.

Other states are establishing potency limits

The use of products high in THC has been linked to greater risk of cannabis dependence and adverse mental health outcomes. Concerns about product potency have led all states with recreational marijuana markets to limit the amount of delta-9 THC in edible products. This threshold is typically around 10 milligrams, a dose that’s strong enough to affect most people.

Hemp is a different story. To satisfy federal requirements, hemp just has to have less than 0.3% delta-9 THC by weight. This limit sounds low, but the weight-based metric does not account for heavier products, like food and drinks.

For example, a 50-gram candy bar – roughly the size of a Snickers bar – with 150 milligrams of hemp-derived delta-9 THC is legal in the 34 states that don’t have milligram caps on hemp products. This is a dose 15 times higher than what any recreational marijuana market allows. Meanwhile, states that only restrict hemp’s delta-9 content also leave the door open to products with high amounts of other forms of THC.

At least 13 states have responded to potency concerns by adding milligram caps on the total THC permitted in a single serving of a hemp product. Some of these limits are so low – 1 milligram or less in Connecticut, New York, Montana and Rhode Island – that one serving is unlikely to cause impairment.

Enforcement is a wild card

Only regulations that are enforced are effective, and states differ in the level of energy they devote to industry oversight.

In Virginia, the Office of Hemp Enforcement has issued over $12 million in fines to noncompliant hemp retailers since its creation in 2023. On the other end of the spectrum, Massachusetts considers hemp-derived THC products illegal, but it has not provided local jurisdictions with funding for enforcement, resulting in continued availability of prohibited products.

Some states with legal hemp markets have added additional sales taxes to help fund enforcement. In Nebraska, Missouri and Connecticut, attorneys general have sued hemp retailers for selling illegal items, marketing to minors and engaging in deceptive trade practices.

As the hemp industry expands, so will concerns about how to protect public health. The demand for THC, and the market to supply it, continues to grow. If lawmakers want to develop industrywide safety standards or deal with the challenges of online marketplaces that sell hemp products to minors, it will take action from Washington. In the meantime, many states and policymakers are exploring an expansive middle ground between unfettered access and blanket bans.

Katharine Neill Harris, Fellow in Drug Policy, Rice University

This article is republished from The Conversation under a Creative Commons license. Read the original article.