New York’s Making It Easier for Makers to Start Selling from Their Home Kitchens

Originally published by Edible Brooklyn on September 27, 2018. Written by Lisa Held.

What do the founders of Early Bird GranolaPilot Kombucha, and Hungry Bird Eats have in common?

They started baking oats, fermenting tea and rolling crackers at home before turning their kitchen habits into food businesses.

It’s a story that’s so common it’s become a trope: Cool Brooklynite makes innovative food for friends. Friends urge him or her to sell said food. Food becomes top seller at Whole Foods.

However, there are many factors that influence how successful makers are at moving through that timeline, and a new report from Harvard Law School’s Food Law and Policy Clinic digs into one that doesn’t get a lot of attention: state laws that regulate the sale of small-batch foods made outside commercial kitchens.

“Cottage Food Laws in the United States” provides a comprehensive overview of how states create legislation and regulations related to cottage foods, common elements from state to state (like which foods are allowed and sales limits) and recommendations to strengthen laws.

It’s an important resource for makers in Brooklyn (and across the country) who are just starting out and may find it difficult to navigate issues like which foods they can make and where they can sell.

The team at food incubator Pilotworks, for example, said that it was common for students in its Launchpad program to experiment with production and sales from home kitchens before moving into a production facility like theirs, and that helping makers understand regulations is a critical role they fill. “We have to be deeply knowledgeable about federal, state and local regulations and how they apply to all types of food companies, large and small.”

In terms of findings (and especially given Brooklyn’s reputation as a maker mecca), how did New York’s cottage food law stack up against others across the country?

Emily Broad Leib, director of the Food Law and Policy Clinic and one of the authors of the report, said that New York’s law is generally supportive of cottage food producers and has eliminated most big barriers. “For example, New York is one of only a dozen states that allows for some wholesale sales of cottage food products, and one of 17 states that explicitly allow for online sales, which 13 states explicitly prohibit. It is also more permissive than many states by not setting an annual gross sales limit,” she said. “Further, New York meets one of our most important recommendations to provide easy-to-follow guidance, so cottage food producers are able to take advantage of the exemptions and know where to find relevant information.” (That information is available through the Department of Agriculture.)

The one area that the state could improve upon, Broad Leib said, is expanding the kinds of cottage foods that are allowed, since they are restricted to a specific list. State laws tend to allow for what they consider low-risk foods (like baked goods, jam and shelf-stable sauces) in terms of food safety concerns, since these small-batch businesses are often not required to adhere to the food safety regulations of bigger companies. (High-risk foods include dairy, meat, fish, eggs and so forth that require time and temperature controls to prevent the growth of microorganisms and the production of toxins.)

Another big finding from the report is that, nationwide, more states are introducing cottage food laws. Every state except New Jersey now has one, compared to 42 states in 2013, and a few states (like Wyoming) have introduced new “food freedom” laws that essentially allow almost any foods to be sold to an “informed consumer.” “Many states that allowed some cottage foods in 2013 have also broadened their laws to allow more types of sales,” Broad Leib added.

The authors of the report see this shift as overwhelmingly positive and write that making it easier for small-batch food producers to get started supports local food economies. Evidence on the impacts of the laws, however, is basically nonexistent, and Broad Leib sees it as an area ripe for research.

“What we do know is that there is a lot of consumer interest in purchasing food from their neighbors and from within their own communities, whether or not this food follows safety regulations, and that there are many producers interested in using cottage food production as an avenue to start a small business, or at least to test out their markets before building a more traditional food business,” she said. “To the extent that cottage food laws allow these new market opportunities to take place without any costs to the state, they bring a lot of benefit.” In other words, other states likely want in on the Brooklyn maker phenomenon, too.


Courts Force States to Provide Costly Hep C Treatment

Originally published by Stateline/The Pew Charitable Trusts on September 25, 2018. Written by Michael Ollove.


Editor’s note: This story has been updated to include comment from Arkansas, Kansas, and Missouri.

A series of recent court rulings and settlements, including one last week in Indiana, have found that states cannot withhold potentially life-saving but expensive medications from Medicaid beneficiaries and prison inmates who have chronic hepatitis C.

Hepatitis C kills far more Americans than any other infectious disease. But when new antiviral drugs that for the first time promised a cure for hepatitis C hit the market in 2014, states blanched at their eye-popping prices and took steps to sharply limit the availability of those treatments for Medicaid beneficiaries and inmates. According to one recent survey, only 3 percent of inmates in state penitentiaries with hepatitis C receive the cure.

The antiviral drugs have since become cheaper, but judicial decisions and settlements have consistently found that states cannot deny treatment because of cost in any case.

In the latest ruling, U.S. District Judge Jane Magnus-Stinson, chief judge of the U.S. Southern District of Indiana, said that withholding or delaying treatment from hepatitis C-infected inmates was unconstitutional, amounting to cruel and unusual punishment in violation of the Eighth Amendment. The U.S. Constitution requires state penitentiaries to provide health care to prisoners.

The ruling follows a similar decision in Florida last year and settlements reached this year in Massachusetts and Colorado that require correctional systems in those states to provide treatment to virtually all infected inmates. Colorado has set aside $41 million over two years to treat all inmates with the virus. Similar lawsuits are pending in Pennsylvania, Minnesota, Missouri and Tennessee.

Likewise, states have been on the losing end of lawsuits involving Medicaid beneficiaries who have been denied hepatitis C treatments in Colorado, Michigan, Missouri and Washington, forcing changes in policies to make the cure more broadly available. And settlements have been reached elsewhere, including in Pennsylvania, Massachusetts and Florida, according to the Center for Health Law and Policy Innovation at Harvard University. States run Medicaid agencies, which provide health care to the poor, and split the costs with the federal government.

While providing the treatments will cost states tens of millions of dollars, health policy experts insist the spending will provide an overall economic and public health benefit. Attacking hepatitis C in prisoners and in Medicaid patients, they say, will go a long way toward eradicating the disease while also saving money by preventing patients with untreated hepatitis C from progressing to liver failure and cancer.

“The most important thing to remember about cost-effectiveness is that something that is really expensive can still be cost-effective if it is really, really effective,” said Mark Roberts, chairman of the University of Pittsburgh department of health policy and management who has written studies about the new hepatitis C medications. “And these drugs are very, very effective.”

A Cure Arrives

The new antivirals, approved by the U.S. Food and Drug Administration late in 2013 and first sold the following year, represented a giant leap from previous treatments. The treatment period for the old drugs lasted as long as 48 weeks, entailed severe side effects, and delivered a cure rate lower than 50 percent.

By contrast, the new antivirals usually require 12-week treatment periods, carry virtually no side effects and boast an effective rate above 95 percent. For the estimated 3.5 million Americans with hepatitis C, the new drugs promise a pain-free cure. Hepatitis C is particularly prevalent among baby boomers, who were susceptible to the disease at a time when infection controls were less prevalent, and among drug users who share contaminated needles.

When the drugs first hit the market, a single course of treatment cost as much as $84,000.

“States were terrified by their cost exposure,” said Matt Salo, executive director of the National Association of Medicaid Directors. “And they had no idea how many people would show up on Day One demanding the cure. Would it be 75 percent? Twenty-five percent? One percent? They had no idea what their exposure was.”

The prevalence of hepatitis C is thought to be higher among Medicaid beneficiaries than the general population, Salo said, with estimates ranging from 700,000 to 1 million Medicaid patients infected. And the rate is higher still in prisons because of illicit drug use and do-it-yourself tattooing common in penitentiaries. The Centers for Disease Control and Prevention estimates that 1 in 3 prisoners in U.S. jails and prisons has hepatitis C.

In response to the high prices, state Medicaid agencies and prisons decided to essentially ration the new drugs.

They relied on blood tests to determine the severity of a patient’s disease, measuring the level of fibrosis, or liver scarring. Patients were given scores, from F0 (no fibrosis) to F4 (cirrhosis, or late-stage scarring of the liver).

In the corrections and Medicaid systems, only patients with higher scores were eligible for treatment. Many states also denied treatment to active drug users, and in Medicaid programs, they limited the numbers of doctors who could prescribe the new antivirals.

Nationwide, at least 144,000 inmates at state prisons with hepatitis C (97 percent) aren’t getting the cure, according to a new survey by Siraphob “Randy” Thanthong-Knight at Columbia University’s Graduate School of Journalism.

In Vermont, according to VTDigger, one state lawmaker called it “appalling” when he learned at a legislative hearing last week that in 2017, of 258 state prisoners with hepatitis C, only one had received the cure.


Those restrictions drew a firestorm of criticism, not only from advocates for Medicaid beneficiaries and prisoners, but from human rights and medical organizations, such as the Infectious Diseases Society of America and the World Health Organization. Many argued that policymakers stigmatized patients with hepatitis C in a way they would never consider with other diseases.

“If there were a cure for breast cancer or Alzheimer’s or diabetes, people would be storming the White House to make sure those medicines were available to everyone, you can be sure of that,” said Robert Greenwald, a professor at Harvard Law School and the faculty director of the school’s Center for Health Law and Policy Innovation. “But we’ve responded completely differently with the cure for hepatitis C because of the stigma associated with that disease.”

Greenwald and others insist that treating prisoners with hepatitis C is an indispensable step toward eradicating the disease in the whole population.

Stateline contacted communication offices for a dozen state Medicaid offices that restrict hepatitis C antivirals to patients with fibrosis scores of F3 or F4. Three states, Missouri, Kansas and Arkansas, responded. Officials from Kansas and Missouri said they dropped their disease severity restrictions for Medicaid beneficiaries with hepatitis C. A spokeswoman for the Arkansas Department of Human Services wrote in an email: “We continue to monitor what other states are doing, and how it compares to our current policies, to identify the need for potential changes.”

In 2015, the Obama administration urged state Medicaid agencies to lift restrictions on the drugs. By 2017, at least 17 states lifted restrictions based on severity. Many others retained the restrictions but loosened them to make the drugs available to beneficiaries with less severe liver damage.

The movement in prisons has been slower, nudged along mainly by the lawsuits. “They have been slow to respond,” said Tina Broder, interim executive director of the National Viral Hepatitis Roundtable, a coalition working to eradicate hepatitis B and C.

Kellie Wasko, deputy executive director at the Colorado Department of Corrections, said the settlement the state reached with the American Civil Liberties Union last month only formalized what the state had decided to do on its own, which was to treat all the estimated 2,200 Colorado prisoners with hepatitis C.

“As a health care professional, I do believe it is right to treat everybody,” said Wasko, who is a nurse.

She acknowledged that the drugs’ lower costs made the decision easier for the prison administrators and the legislators who appropriated the $41 million for treatment.

Originally, she said, the price for a single course of treatment was $56,000. Because of contract requirements, she said she couldn’t reveal the price Colorado pays now, but “it is significantly less.”

Other experts say that with discounts, Medicaid and corrections systems can now pay as little as $10,000 for a course of treatment.

“Even at those prices,” Harvard’s Greenwald said, “states are waiting for us to litigate before they’ll remove these restrictions. And the only explanation for that is the stigma.”

New Frontiers in Homemade Food

Written by Amy Hoover, FLPC summer intern and Cottage Food Laws in America report co-author

UPDATE: On September 18th, California Governor Jerry Brown signed AB 626 into law. The new law, which goes into effect on January 1, 2019, opens a new frontier for home cooks selling food in California and creates a new model for the state laws that govern homemade foods.

An innovative bill on the verge of being signed into law in California could create a new frontier in the state laws that allow cooks to sell food made in home kitchens. Building on the success of cottage food laws, which allow food producers to sell certain low-risk homemade foods, this new law would open up sales opportunities for entrepreneurs selling a wider array of foods, including hot meals, made in their homes.

Cottage food laws are now commonplace across the United States. In the timespan between FLPC’s 2013 report on cottage foods and our new report released last month, cottage food laws passed in seven additional states and the District of Columbia, bringing the total of states with cottage food laws to 49. Furthermore, many states have updated their cottage food rules to expand the types of products or scale of production that is allowed under their cottage food provisions.

Although cottage food laws vary tremendously from state to state in their details (just check out our 50-state appendix for an interesting snapshot of federalism at work), most have traditionally followed a fairly standard basic structure. These laws typically allow home cooks to sell limited types or categories of foods that pose low food safety risks when held at room temperature, subject to certain sales limits. Higher-risk food items that require time and temperature control for safety, such as meats, cooked vegetables, and premade meals, are not allowed under these cottage food laws.

All cottage food laws followed this basic pattern until 2015, when Wyoming broke away from the typical cottage food law with its food freedom law. In contrast to other cottage food laws, Wyoming’s law removes almost all limitations on what types of foods home producers can sell. It requires only that cottage food producers sell directly to “informed end consumers” for home consumption. Within these limits, home food producers’ actions are not regulated by the state. Since Wyoming’s food freedom law passed, North Dakota and Illinois have also passed laws based on this model (although with more constraints than Wyoming’s law).

Another new frontier in homemade foods is now on the horizon in California, where a coalition of food advocates is on the verge of securing enactment of A.B. 626. If (or at this point, perhaps when) A.B. 626 becomes law, in addition to making low-risk foods under the state’s existing cottage food law, home producers will have another, more expansive option: the proposed law would allow home cooks to sell almost any foods, including hot prepared meals. Within the proposed law’s oversight and food safety framework, home cooks in California would be able to make and sell foods that need time and temperature control for safety—exactly what almost every cottage food law forbids.

Although both California and Wyoming have sought to broaden the types of foods that home producers can sell, A.B. 626 innovates in a very different way from Wyoming’s food freedom law. Wyoming’s law exempts homemade food producers from any state oversight. In contrast, the California bill allows home cooking but subjects “microenterprise home kitchens” to a new set of regulations. The bill’s permitting and licensing requirements (more than for cottage food producers; less than for commercial food operations) are designed to create a new avenue of economic opportunity for home cooks while ensuring food safety.

Alongside its innovative elements, A.B. 626 retains several of the features that have helped cottage food laws successfully balance food entrepreneurship and food safety. It allows only direct sales, on the theory that a personal interaction between cook and consumer can create a relationship that reduces the need for government oversight. It also limits annual gross sales, number of meals sold, and number of employees, meaning that only micro-scale operations are allowed under the proposed law. But even these small operations can help home cooks make some extra money and test the market before they scale up and face the costs of complying with the full array of food safety regulations for commercial operations.

With overwhelming bipartisan support, A.B. 626 is well on its way to becoming law. It passed California’s Assembly on January 29th, and just recently, on August 28th, it passed California’s Senate. Now, Governor Jerry Brown has until September 30th to sign the bill into law. Its enactment can provide a new model for homemade food sales and may well set the stage for future shifts in cottage food laws nationwide.

In California and other states across the nation, food entrepreneurs, lawmakers, and regulators are innovating and experimenting to open up new opportunities for safe and delicious homemade foods. To learn more about the recent trends in cottage food laws nationwide, check FLPC’s new definitive guide, Cottage Food Laws in the United States.


29 Little Ways to Cut Back on Food Waste

Prevention magazine recently wrote an article full of ideas to reduce food waste, quoting FLPC Director Emily Broad Leib in the article.


Excerpt below:

Give milk the sniff test

Think the “sell by” or “use by” dates are there to prevent illnesses? Nope. “They’re not based on any safety test,” says Emily Broad Leib, director of the Food Law and Policy Clinic at Harvard Law School. “Most are just manufacturers’ suggestions for quality, and they vary widely.” If you regularly pitch things whose dates say they’ve just expired, you’re probably throwing away foods that are perfectly fine to eat. Still nervous? Check the USDA’s FoodKeeper app to double-check: It tells you how long various foods typically last.

Read the full article here.


Take Two Carrots and Call Me in the Morning

Originally published by Stateline for Pew Charitable Trust on September 7, 2018. Written by Marsha Mercer.

Half a century after Americans began fighting hunger with monthly food stamps, the nation’s physicians and policymakers are focusing more than ever on what’s on each person’s plate.

In the 21st century, food is seen as medicine — and a tool to cut health care costs.

The “food is medicine” concept is simple: If chronically ill people eat a nutritious diet, they’ll need fewer medications, emergency room visits and hospital readmissions.

The food is medicine spectrum ranges from simply encouraging people to plant a garden and learn to cook healthfully, as state Sen. Judy Lee, a Republican, does in North Dakota — “We don’t do policies about gardening,” she said — to an intensive California pilot project that delivers two medically tailored meals plus snacks daily and offers three counseling sessions with a registered dietitian over 12 weeks.

The California Legislature last year became the first in the nation to fund a large-scale pilot project to test food is medicine. The three-year, $6 million project launched in April will serve about a thousand patients with congestive heart failure in seven counties.

“The state puts a huge amount of money into health care, and one of the biggest costs is medication,” Assemblyman Phil Ting, a Democrat and chairman of the Assembly Budget Committee, said in an interview. “So the hope is people will live longer and this project will also reduce the need for medication.”

The food is medicine concept has been around for a while. Since the 1980s, nonprofits such as Project Open Hand in San Francisco, Community Servings in Boston, God’s Love We Deliver in New York and MANNA or Metropolitan Area Neighborhood Nutrition Alliance in Philadelphia have provided medically tailored meals for patients with HIV, diabetes, cancer and heart disease. They are largely funded by donations and grants.

Seeing the programs’ successes, some states are taking a larger role. Massachusetts is developing a food is medicine plan with a goal of integrating programs scattered around the state so more residents can benefit. Legislative policy proposals are expected next spring.

Food is medicine goes beyond traditional advice to eat more fruits and vegetables. Projects pay for people to purchase produce and offer nutrition counseling and cooking classes, so they’ll know which foods to choose or avoid and how to prepare them. For example, watermelon is healthy for some, but not for a diabetic.  

On the local level, a community garden managed by a teenager in Sylvester, Georgia, aims — with the help of the local hospital — to improve the health of the town in the nation’s “stroke belt.”

Physicians in a dozen states write “prescriptions” for fruits and vegetables at farmers markets and groceries — scripts that can be exchanged for tokens to buy produce.

“Food is medicine is an idea whose day has arrived,” said Robert Greenwald, faculty director of the Harvard Law School’s Center for Health Law and Policy Innovation, one of the experts who testified in January at the launch of the congressional Food is Medicine Working Group, part of the House Hunger Caucus.

The Senate version of the farm bill includes Harvesting Health, a pilot project to test fruit-and-vegetable prescriptions. It’s modeled on work by Wholesome Wave, a Bridgeport, Connecticut, nonprofit that works with health centers in a dozen states where doctors write prescriptions for produce.

If enacted, the federal government would spend $20 million over five years on grants to states or nonprofits to provide fruits and vegetables and nutrition education to low-income patients with diet-related conditions.

The Supplemental Nutrition Assistance Program, the food stamp program known as SNAP, helps reduce food insecurity for 39.6 million participants, but studies do not show SNAP improves nutrition. Instead, there seems to be a correlation between long-term food stamp participation and excess weight gain.

Poor diet was No. 1 of 17 leading risk factors for death in the United States in 2016 — a higher risk than smoking, drug use, lack of exercise and other factors, according to “The State of US Health,” a comprehensive report by a team of academics published in the Journal of the American Medical Association in April.

Dr. Kumara Sidhartha, an internal medicine specialist and medical director at Emerald Physicians on Cape Cod, Massachusetts, conducted a prescription study with Medicaid participants in 2016 and 2017. In his study, he wrote prescriptions or vouchers for one group to buy $30 in produce a week at the farmers market, and gave another $30 in gasoline vouchers a week — for 12 weeks. Both groups received cooking classes and nutrition counseling.

Twenty-four people completed the program, and those who received the fruit and vegetable prescriptions showed improvements in risk factors for chronic disease — better body mass index, total blood cholesterol, LDL cholesterol, blood glucose and hemoglobin A1c, Sidhartha said.

“Patients and physicians are so used to the physician writing prescriptions for procedures and pills,” he said. “This changes the health care culture of how the prescription is used.”  

Proponents of the California project hope it will demonstrate the cost-effectiveness of including medically tailored meals as an essential health benefit covered by Medi-Cal, California’s Medicaid program.

“This is potentially transformative because the health care system has been designed to cover acute services, and not many prevention programs are covered,” said Dr. Hilary Seligman, an associate professor at the University of California-San Francisco, one of two physician researchers who will evaluate the project by tracking participants’ medical records.

“For someone with congestive heart failure, their lives depend on their capacity to eat a lower salt diet,” Seligman said. “Making the food as appealing as possible is very important.”

Some legislators are skeptical about government moving into new food delivery systems.

“We need to feed the children who are hungry now. We need the backpack programs in school, the free and reduced-price breakfast and lunches to make sure that nobody is hungry today,” said North Dakota’s Lee, chairwoman of the state Senate Human Services Committee, at a food is medicine session at the National Conference of State Legislatures (NCSL) Hunger Partnership conference in July.

“But then we need to take those same children and help them learn how to do those things for themselves,” Lee said. “Let’s have a short-term solution: Let’s feed people. And then let’s have a longer-term solution: Help them feed themselves.”

Everyone in her state could have a garden, even apartment-dwellers, and they can learn to cook, she said, adding that cooking is a skill that’s been lost since schools there dropped home economics.

“Kids can learn and a parent can learn how to make a meal,” Lee said in an interview. “I’d rather figure out a way to give them cooking lessons with food. We’re not helping children become functional adults by giving them three meals a day.”

It’s not government’s job to provide every meal, she said, adding, “That’s the good news about North Dakota, compared with the Northeast and California.” 

Georgia state Sen. Renee Unterman, a Republican and chairwoman of the state Senate Health and Human Services Committee and co-chairwoman of the NCSL hunger partnership, suggested at the food is medicine session that a community garden with a medical purpose in her state — and started by a child — could be a model.

Village Community Garden manager Janya Green was 12 when she started on the community garden as her 4-H Club project three years ago on 5 acres donated by the town of Sylvester, population 6,000, about 170 miles south of Atlanta. Anyone can pick free vegetables and fruit whenever they like. The garden features cabbage, carrots, kale, okra, bell peppers, squash, sweet potatoes, blackberries, blueberries, muscadine grapes and even bananas. Herbs are next.

A pond is stocked with fish, so residents can reel in healthy protein as well. A local county commissioner gave lumber for a 20- by 60-foot stage.

Phoebe Worth Medical Center installed an outdoor kitchen in the garden for chef-taught cooking classes. Darrell Sabbs, governmental affairs specialist at the medical center, hopes researchers from Emory University or the University of Georgia will study the health statistics of the neighborhood and gauge the garden’s health effects.

Dr. Marilyn Carter, an internal medicine physician who also trained as a pharmacist, lives in Sylvester and volunteers at the garden. She and a nutritionist wrote up health benefits of the produce for signs that will help people make smart choices.

“We’re in the stroke belt,” Carter pointed out, adding that many of her patients have heart disease and diabetes. People eat a typical Southern diet of fried foods and foods out of boxes that are high calorie and high fat, she said.

“I want people to know, ‘If I eat more kale and less white rice, my blood pressure will be better,’” she said. Her name for the garden: the Farmacy.