What Fermenters Need to Know About Probiotics Regulations
Probiotics are the third most popular health product ingredient, with 62% of American consumers buying or wanting to buy them. However, only one-third of consumers say they understand probiotics. That confusion is evident in the courts, where consumer class action lawsuits are continually filed against probiotic food and beverages.
Meanwhile, the probiotics industry is pushing to update 25-year-old dietary supplement laws, there’s a new head of the Food and Drug Administration (FDA) and the lactobacillus taxonomy has been overhauled.
What does all this mean for fermented food and beverage brands? Ivan Wasserman, an attorney with expertise in foods and dietary supplements, says now is the time to plan for legal roadblocks, whether a new product or an existing brand. Wasserman shared his legal expertise during a Natural Products Insider webinar on probiotics regulations and class-action lawsuits.
How Does the FDA Define Probiotics?
It wasn’t until 1994 that probiotics were allowed to be sold as an FDA-approved dietary supplement. But the Dietary Supplement and Health Education Act (DSHEA) of 1994 does not directly define probiotics in their definition of supplements.
“You’ll notice there’s nothing in there about live microorganisms,” Wasserman says.
A line interpreted as a “catch-all” provision covers probiotics. It says a dietary substance can be anything “to supplement the diet by increasing the total dietary intake.” The FDA reviewed DSHEA in 2019, but new draft guidelines don’t provide additional clarification. The draft states: “Bacteria that have never been consumed as food are unlikely to be dietary ingredients.”
Wasserman says that’s not a correct assessment of probiotics. During the review, he noted government leaders who were around during DSHEA’s first passing said dietary supplement should not “be limited to things that are already in the food supply. That would really kill innovation, new strains of probiotics for example that were never in the food supply. It didn’t make sense to them that that would be the intent of congress. It would stifle innovation.”
As the FDA’s time is overwhelming focused on coronavirus, there has been no resolution to the definition of probiotics.
What are the Challenges in Labeling Probiotics?
Current regulations call for labeling probiotics in terms of weight. There is no special provision for live microorganisms; probiotics must be labelled like a vitamin or mineral.
“Unlike milligrams of calcium or vitamin C, we all know weight really isn’t that relevant (for probiotics) because dead bugs have weight, the size of the bug really doesn’t affect its efficacy,” Wasserman says. “It’s really how many live microorganisms you’re getting taking as part of a dietary supplement. That’s how all research is published, that’s how the government refers to it. So CFUs, or colony forming units, has become sort of a defacto way consumers and companies will recognize how much of a live microorganism a probiotic is in a live, dietary supplement.”
The International Probiotics Association petitioned the FDA on this measurement rule, asking for probiotics to be listed in terms of CFUs, not milligrams. The FDA said yes, CFUs would be allowed, but milligrams must also be included.
“It’s just confusing and silly,” Wasserman says.
False Advertising Claims Can Cost Brands Millions
In the past decade, the Federal Trade Commission (FTC) has actively sent warnings to brands making unverified probiotic health claims. The FTC’s first charge for probiotic advertising was filed in 2010 against Nestle BOOST Kid Essentials. Nestle did not have the scientific evidence to back up their health labelling. The FTC said Nestle used “deceptive advertising claims about the health benefits of the children’s drink,” like claiming it would reduce the risk of colds, flu and other respiratory tract infections, claims unproven by the FDA. Nestle also claimed BOOST would reduce children’s sick-day absences and decrease the duration of diarrhea, claims unverified “by at least two well-designed human clinical studies,” the FTC said.
“You have to be extremely careful not to imply or state disease prevention,” Wasserman says. “Probiotics certainly give a boost to the immune system, but…to the FTC, that was too strong of a claim, that this product can literally prevent children from getting sick. You can get in trouble for both imagery and claims. Be very careful.”
Other deceptive advertising cases include:
- In 2010, the largest truth in advertising lawsuit was settled against Dannon yogurt. Dannon claimed their Activia and DanActive yogurt products were “clinically” and “scientifically proven” to regulate digestion and boost the immune system. However, Dannon never proved their claims. Dannon had to pay $45 million in damages, and remove the words “clinically” and “scientifically proven” from their labels.
- In 2018, a class-action lawsuit was filed against Tropicana for marketing the added health benefits in their Essentials Probiotics fruit juices. The drink, though, included nearly the same amount of sugar as soda, and Tropicana did not have adequate scientific evident to support the nutritional claims.
- In 2019, a lawsuit was filed against Brew Dr Kombucha, alleging the kombucha was “falsely advertised and labeled as having a significantly higher amount of probiotic bacteria than the products sold actually contained.” Brew Dr’s kombucha bottle advertised billions of bacteria per bottle, but the plaintiff’s research found only 50,000 CFU’s of probiotic bacteria per bottle. The case is still pending.
- In May 2020, the National Advertising Division (NAD) recommended Benefiber remove the claims “100% natural,” “clinically proven to curb cravings” and “helps you feel full longer” from the Benefiber fiber supplements. Metamucil challenged Benefiber’s claims. Though Benefiber had tested their products and could provide scientific evidence, the NAD said the studies were not relevant to the consumer population. Benefiber’s studies were conducted on factory workers in China who live in a controlled living environment at the warehouse 24/7.
In the last few years, the FTC has been relatively quiet filing warnings against probiotic products. Wasserman theorizes it’s because the benefits of probiotics to digestive health have become well-accepted to the general public. Class-action lawsuits filed against probiotic products have also slowed down.
“That’s not to say they’re not being filed,” Wasserman adds. “We’re not seeing a letdown of those types of letters. Our little law firm is dealing with them on a daily basis for a wide variety of clients in a wide variety of industries. The good news is, because the benefits are so well known of probiotics, we haven’t seen a lot of cases actually being filed against probiotics.”
- Published in Science
Scientists Discover Which Bacteria Transfer to Gut
Scientists in Italy have discovered lactic acid bacteria in fermented food transfers to the gut microbiome. Though this is a widely accepted health benefit of fermented foods, there is little scientific research linking fermented food and the microbiome. The study looked at distribution of lactic acid bacteria (LAB) in humans based on location, age and lifestyle.
LAB genomes were reconstructed from about 300 foods and nearly 10,000 human fecal samples from humans from different continents.
The most frequent LAB food in the human feces: streptococcus thermophilus and lactococcus lactis, commonly found in yogurt and cheese.
“Our large-scale genome-wide analysis demonstrates that closely related LAB strains occur in both food and gut environments and provides unprecedented evidence that fermented foods can be indeed regarded as a possible source of LAB for the gut microbiome.”
Read more (Nature Communications)
Why are Sauerkraut and Kimchi Sales Up During the Pandemic?
People are turning to acidic dishes like sauerkraut and kimchi to protect themselves from the COVID-19 virus. Though there is no scientific evidence that foods like kimchi and sauerkraut will prevent spread of the virus, sales are booming. Health experts say it’s because cabbage is a superfood filled with antioxidants and vitamin C, and the fermented condiments are filled with probiotics that support the gut microbiome. Consumers are hypothesizing that coronavirus death rates in Germany and South Korea because sauerkraut and kimchi are traditional food staples in the two countries. In January, South Korea’s national health ministry issued a press release stressing that kimchi offers no protection against the virus. That hasn’t stopped Americans from buying it – sauerkraut sales surged 960% in March, while kimchi sales jumped 952% in February.
Doctors emphasize that the best way to prevent coronavirus infection is to avoid becoming exposed. Hand washing, social distancing and mask wearing are encouraged.
Read more (New York Post)
Farmer, Nutrition Activist Uses Fermentation Methods to Create Healthier School Lunches
An organic farmer and nutrition activist is teaching schools and daycare centers in Japan to grow their own vegetable garden using fermented compost from recycled food waste, then incorporate into school lunches those fresh vegetables with traditional Japanese fermented foods (like miso and pickles). Two years after the program’s launch, absences due to illness have dropped from an average of 5.4 days to 0.6 days per year.
Farmer Yoshida Toshimichi “is a devout believer in the power of microbes.” Using centuries of Japanese folks wisdom that is supported by modern science, Toshimichi explains that fermentation bacteria in the compost yields hardy, insect-resistance vegetables. He says the key to a healthy immune system is maintaining a diverse and balanced gut microbiota. “Lactobacilli and other friendly microbes found in naturally fermented foods can help maintain a healthy environment in the gut, just as they do in the soil,” continues the article. Microorganisms in fermented foods like miso and soy sauce will help balance gut flora. “Organic vegetables, meanwhile, provide the micronutrients and fiber on which those friendly bacteria thrive. In addition, phytochemicals found in vegetables—especially, fresh organic vegetables in season—are thought to guard against inflammation, which is associated with cancer and various chronic diseases,” the article reads.
Toshimichi has authored books on his farming and nutrition practices and is featured in the two-part documentary film “Itadakimasu,” which translates to “nourishment for the Japanese soul.”
Read more (Nippon)
- Published in Food & Flavor, Health, Science
Peptide Found on Fermented Veggies Aids Antibiotics Research
Microbiologists in Sweden discovered a major breakthrough in antibiotics. Their research found an antibacterial peptide, plantarcin, can be combined with antibiotics to kill the staphylococcus bacteria (MRSA). Staph is a major problem in healthcare, which causes difficult wound infections and, in severe cases, sepsis. This plantarcin peptide comes from good bacteria — it’s found on fermented vegetables, which serve as a natural preservative for the food. The results of the study were published in the journal Scientific Reports. “Administering lower doses of antibiotics when treating infections in turn reduces the risk of further development of antibiotic resistance, which today is a major global threat to public health,” says Torbjörn Bengtsson, professor in medical cell biology at Örebro University.
Read more (Phys.org)
The Science of Yeast, the Microbe in your Pandemic Bread
Humans have been baking fermented breads for at least 10,000 years, but commercial yeast and flour companies have never seen demand so high. National Geographic shares “a story for quarantined times, about extremely tiny organisms that do some of their best work by burping into uncooked dough.”
Scientists describe the microbes behind the work fermenting the bread. “It’s this wonderful living thing you’re working with,” says Anne Madden, a North Carolina State University adjunct biologist who studies microbes. She and partner scientists showed recently that when bakers in different locales use exactly the same ingredients for both starter and bread, their loaves come out smelling and tasting different. “Which I think is fantastic,” she says. “It’s evidence of the unseen. And as a microbiologist, you so rarely get to measure things about microbes with your nose and your taste buds.”
Read more (National Geographic)
- Published in Science
Bubbling Over: How to Prevent Mold in Sauerkraut
Three fermentation experts weigh in on one of the most common problems in fermenting vegetables: mold prevention. The fermenters include fermentation chef David Zilber (head of fermentation at Noma) and fermented sauerkraut producers Meg Chamberlain (co-owner of Fermenti Farm) and Courtlandt Jennings, (founder and CEO of Pickled Planet and TFA advisory board member).
How do you handle prevent mold in sauerkraut?
David Zilber, Noma: That is something you are constantly trying to fight back, especially when you lacto-ferment in something like a crock. There are so many variables that go into making a successful ferment. How clean was your vessel before you put the food in there? How clean were your hands, your utensils? How much salt did you use? How old was the cabbage you were even trying to ferment in the first place? Every little detail is basically another variable in the equation that leads to a fermented product being amazing or terrible. It’s a little bit like chaos theory, it’s a little bit like a butterfly flapping its wings in Thailand and causing a tornado in Ohio. But with lots of practice, you’ll begin to understand that, if it was 30 degrees that day, maybe things were getting a little too active, maybe the fermentation was happening a little bit too quickly. Maybe I opened it a couple times more than I should of and it was open to the air instead of being covered. So there’s lots of variables. But I would say that, if you’re having a lot of trouble with mold, just up the salt percentage by a couple percent. It will make for a saltier sauerkraut, but it will actually help to keep those microbes at bay. (Science Friday)
Meg Chamberlain, Fermenti Farm: You must allow the ferment to thrive by creating a favorable environment with “Good Kitchen Practices.” So, to prevent mold in your ferment start by using only purified water, like reverse osmosis, distilled or boiled and cooled and-no tap water(municipal). Only use vegetable-based soap that is NOT anti-bacterial, like a good castile soap. Finally, only use dry fine Sea Salt, no mineral/no gourmet or iodized. Keep Fermenting and do not get discouraged! #youcanfermentthat #diyfermentation #idfermentthat
Courtlandt Jennings, Pickled Planet: Preventing mold when making sauerkraut is all about a controlled atmosphere. How well you maintain your situational cleanliness and fermenting atmosphere is my best clue for you. There are many ways to control atmosphere and every situation will be different based on many factors but be dillegent and your ferments will improve with practice.
This may not seem like an answer but it’s directional… as is most advice unless dealing with a consultant. Good luck and may the ferment force be with you!
- Published in Food & Flavor, Science
Sourdough Library Catalogues Hundreds of “Mothers”
The man behind the world’s only sourdough library shares how he maintains a collection of 125 sourdough mothers from all over the world. The mothers are stored in Mason jars in a chilled cabinet. Library founder Karl De Smedt cares for them in France, refreshing the jars every two months with back stocks of the original flours used (and contributed) by the providers. De Smedt travels the world for new mothers, prioritizing “renown, unusual origins, the type of flour used, and the starter’s approximate age.” He adds up to two dozen new sourdoughs each year, ranging from cooking schools, home-bakers, pizzerias, artisan and industrial bakers.
“Most importantly, the sourdough must come from a spontaneous fermentation, and not inoculated with a commercial starter culture,” De Smedt says. “Sourdough is the soul of many bakeries. When bakers entrust you with their souls, you’d better take care of it.”
Read more (New York Times)
- Published in Science
What Gives Kimchi its Bacteria Superpower?
A fascinating study by the World Institute of Kimchi (WiKim) found that the cabbage in kimchi is a key source of lactobacilli in the fermented product. Garlic also contributes to the lactobacilli, while ginger and red pepper did not contribute. Of note, neither cabbage or garlic alone could replicate the final community of fermented kimchi. All vegetables were needed to bring the full bacterial community. The findings were published in the journal Food Chemistry. Researchers say it’s a building block to further understand food.
Peter Belenky, a professor of molecular microbiology and immunology who analyzed the study, said: “I think really what it tells us is that, yes, some ingredients bring specific bacteria, but you really need everybody working together in order to bring the full community.”
Read more (Popular Science)
- Published in Science
Fermenting “Cowcohol”
Oregon-based TMK Creamery is using the leftover whey byproduct from their cheese and fermenting it into vodka. They call it “cowcohol” and the flavor has a carmel-like sweetness with a smooth finish. Owner Todd Koch learned about the method from Dr. Paul Hughes, assistant professor of Distilled Spirits at Oregon State University. Hughes began experimenting with fermenting whey into a spirits base and has now helped more than a dozen creameries all over the U.S. ferment their whey into alcohol.
Fermenting upcycles the whey while bringing some attention to the animals, Koch said. Artisanal creameries typically have to pay thousands of dollars to dispose of whey in landfills.
From Atlas Obscura: Whey fermentation offers a brave, new world for small creameries, both in decreasing their environmental footprint and ensuring financial security in an age of mass conglomeration. For Koch, a life-long, self-proclaimed “cow person,” the possibilities of bovine booze are a relief to him and his beloved herd. “Going through college, I was like ‘Man, if I could just figure out how to get cows to make alcohol, we’d be set,’” he says. “So I guess we’re one step closer here.”
Read more (Atlas Obscura)