What Fermenters Need to Know About Probiotic Regulations

/ / Legal & Regulatory

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.”