Products with Probiotics
Challenges
Regulatory Issues
Safety Issues
Commercial Probiotic Strains
Retail Product Information

In the United States, most probiotic products are either foods or dietary supplements. A few probiotics are marketed as medical foods. Although fermented dairy products such as yogurt and kefir are typically associated with delivery of "beneficial cultures", the types of foods claiming to deliver probiotics has expanded to include granola and candy bars, frozen yogurt, cereal, juice and cookies. Whether or not any given product, even ones that claim to contain "probiotics", actually deliver adequate amounts of efficacious probiotic strains cannot be ascertained from just looking at the product. In general, consumers need to contact the manufacturer to determine what studies have been conducted on their specific product as formulated and what health benefits should be expected.

In food products, the probiotics used are primarily species of Lactobacillus or Bifidobacterium, or Streptococcus thermophilus.

In the United States, yogurt is required to be produced by the fermentation by Lactobacillus bulgaricus and Streptococcus thermophilus. However, post-fermentation heat treatment of yogurt, which kills all live cultures, is allowed. To help consumers distinguish between yogurts that contain live active cultures and those that do not, the National Yogurt Association established a "Live Active Culture" seal. The seal is available for use by any yogurt manufacturer on packaging and requires refrigerated yogurt to contain 10⁸ viable lactic acid bacteria per gram at the time of manufacture. The seal also can be used on frozen yogurts containing 10⁷ viable lactic acid bacteria per gram at time of manufacture. However, these counts do not differentiate probiotic bacteria from starter culture bacteria (L. bulgaricus and S. thermophilus), and therefore the seal is not useful in determining if adequate levels of added probiotic bacteria are present in a yogurt. In other words, the standard refers to a total number of live cultures and levels of each microbe present do not have to individually meet the standard. The NYA is also currently petitioning the United States government to have the standard of identity of yogurt changed to require that the starter cultures be viable in the finished yogurt.

The dietary supplement market for probiotic cultures seems to be a more diverse and more active market than probiotics for dairy. The supplement market contains many different product formats and contents, including capsules, liquids, tablets and even food-like formats. If properly prepared and stored, probiotic bacteria can remain viable in dried form and reach the intestine alive when consumed. A diverse array of bacterial genera and species are represented in these products, including many different lactobacilli, bifidobacteria and less commonly, Enterococcus, Bacillus, Escherichia coli and yeast. Dietary supplement products are purchased primarily in health food stores or natural foods grocery stores.

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Challenges for commercialization of probiotics in the U.S. include:

• Uncertainty of the food industry regarding mainstream consumer acceptance of probiotic products, partially due to poor consumer awareness of potential benefits and an association by consumers of bacteria as being "bad."
• Lack of unique, appealing product formats with probiotics
• Concern over how to label products with health messages to attract consumer interest while meeting federal regulations
• Need for definitive scientific proof for extent of certain health effects associated with probiotics

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Probiotics could potentially be regulated as a variety of different products in the United States:

• Conventional foods (For consumption by general population)
• Dietary supplements (A subcategory of foods, the dietary supplement category was created in 1994 by the Dietary Supplement Health and Education Act. The products are meant to be used as oral supplements to the diet, and are not to be represented as meals. However, labels can stipulate target population.)
• Medical foods (Foods used under medical supervision for patients needing special dietary support for medical condition.)
• Drugs (A drug is meant to cure, treat, mitigate, prevent, diagnose or cure disease. Drugs composed of live microbes are deemed "biologics" by the FDA's Center for Biological Evaluation and Research.)
• Drugs for animal use
• Drugs for human use
• Feed additives (Termed "Direct fed microbials" by the USDA.)

The same probiotic strain could in theory be used in any of these regulatory categories, assuming that evidence for efficacy in the target host is available. The regulatory category of a probiotic product is determined by:

• Intended use (which is largely defined by the nature of the claims made)
• Formulation (for example, capsules and pills cannot be conventional foods)
• Route of administration (foods and supplements must be orally administered)
• Target consumers (Conventional foods are meant to be consumed by the general public; animal vs. humans)
• Safety (Foods must be comprised of GRAS substances or approved food additives only. No "risk vs. benefit" analysis is allowed for foods, but OK with drugs)

If a product claims to have an effect on the cure, treatment, prevention, mitigation or diagnosis of a disease (e.g., "helps control symptoms of antibiotic associated diarrhea"), the product is a drug. Claims of health benefits on foods must be of one of two types:

• Reduction of the risk of disease is allowed, but only if approved by FDA or an authoritative body. These claims may be qualified. Evidence to support these claims must be generated on healthy population and must be published. Currently, there are no approved health claims for probiotics.
• Structure function claims. These claims relate the food or ingredient to normal functioning of the human body. No approval or notification required for such claims to be used on foods. For use on dietary supplements, FDA notification is required.

In the United States, it is essential to have scientific substantiation for structure/function claims. The burden of proof rests with the manufacturer. Although the FDA does not require premarket approval of such statements, the manufacturer must provide scientific justification for use of any health statements if asked by the FDA. In 2004, the FDA Center for Food Safety and Applied Nutrition published a Guidance for Industry on "Substantiation for Dietary Supplement Claims". This document describes the amount, type, and quality of evidence FDA recommends a manufacturer have to substantiate a claim. Although targeted toward dietary supplements, the concepts are applicable for structure/function statements made on food.

• USFDA publication, FDA Consumer, provides consumer-friendly discussions of FDA positions on labeling of dietary supplements, functional foods, and conventional foods marketed to the health-conscious.
• FAO/WHO Guidelines for Evaluation of Probiotics in Food.
• Canada's updated guidelines for Natural Health Products Regulations.
• Page 26 of the following monograph includes specifications for a probiotic product for Canada. The USA has no such government standards for probiotics. This is for health products, not food (read more).

With regard to the regulations on product quality, the FDA issued (August 24, 2007) a final ruling establishing regulations to require current good manufacturing practices for dietary supplements to be phased in over the next few years. Although these regulations don't address verification of efficacy claims, they will hopefully improve the compositional quality (identity, purity, and strength) of probiotic supplements on the U.S. market (read more; read more). This ruling, however, does not apply to conventional foods, only dietary supplements.

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Although the safety of traditional lactic starter bacteria has never been in question, the more recent use of intestinal isolates of bacteria delivered in high numbers to consumers with potentially compromised health has raised the question of safety. In the U.S., Title 21 of the Code of Federal Regulations (21 CFR) and the FDA Office of Premarket Approval lists microorganisms which are approved food additives or which enjoy Generally Recognized as Safe (GRAS) status. It should be kept in mind, however, that "GRAS" status is only for a specified, food use. (It is not a term that applies to dietary supplements.) The microbes themselves are not considered GRAS, but their traditional use in dairy foods is. This list specifies that harmless lactic acid producing bacteria, including Lactobacillus acidophilus, used as optional ingredients in specified standardized foods (such as yogurt and buttermilk) are sanctioned. In addition, this list specifically includes Streptococcus (thermophilus, cremoris, lactis, and lactis subsp. diacetylactis) Lactobacillus (bulgaricus, fermentum, lactis), and three Leuconostoc species. Note that several probiotic Lactobacillus species (e.g., reuteri, casei, paracasei, gasseri, plantarum) and bifidobacteria are not specifically on this GRAS list. However, the acknowledged nature of this list is that it is partial and the absence of a microbe on this list does not imply it is not safe for use. These species are accepted as safe in Japan and Europe.

A notable development with regard to safety assessment is that the FDA approved the use of B. lactis Bb12 and S. thermophilus Th4 for use in infant formula (read more).

The safety of lactobacilli and bifidobacteria has been reviewed by qualified experts in the field. The general conclusion is that the pathogenic potential of lactobacilli and bifidobacteria is quite low (read more). This is based on the prevalence of these microbes in fermented food, as normal colonizers of the human body, and the low level of infection attributed to them. However, reports of association of lactobacilli and bifidobacteria with human infection (commonly endocarditis) in patients with compromised health suggest that these microbes have rare opportunistic capability.

Regarding the safety of enterococci, the picture is less clear-cut (read more). Foods containing enterococci are safely consumed on a regular basis. However, safety reports seem to agree that the enterococci pose a greater threat than other lactic acid bacteria. Enterococci have been isolated from clinical infections as well as bloodstream and endocarditis infections. Enterococcus-mediated infections of the biliairy tract, urogenital tract, the abdomen, burn wounds, surgical wounds, and many others have been reported. Often, enterococci are isolated as pure cultures from these infections, showing their primary pathogenic nature. In the United States, vancomycin resistant enterococci are the number one cause of hospital-acquired infections. These observations and contradictory characteristics of enterococci justify the scrutiny of these microorganisms as probiotic agents.

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This table lists some commercial probiotic strains currently available. Probiotic species are listed as reported by manufacturer. This speciation may not reflect the most current taxonomy.

Strain	Commercial products	Source
L. acidophilus NCFM® B. lactis HN019 (DR10) L. rhamnosus HN001 (DR20)	Sold as ingredient	Danisco (Madison WI)
Saccharomyces cerevisiae (boulardii)	Florastor	Biocodex (Creswell OR)
B. infantis 35264	Align®	Procter & Gamble (Mason OH)
L. fermentum VRI003 (PCC)	Sold as ingredient	Probiomics (Eveleigh, Australia)
L. rhamnosus R0011 L. acidophilus R0052	Sold as ingredient	Institut Rosell (Montreal, Canada)
L. acidophilus LA5 L. paracasei CRL 431	Sold as ingredient	Chr. Hansen (Milwaukee WI)
B. lactis Bb-12	Good Start Natural Cultures® infant formula	Nestle (Glendale, CA) Chr. Hansen (Milwaukee WI)
L. casei Shirota B. breve strain Yakult	Yakult®	Yakult (Tokyo, Japan)
L. casei DN-114 001 ("L. casei Immunitas™") B. animalis DN173 010 ("Bifidis regularis™")	DanActive® fermented milk Activia® yogurt	Danone (Paris, France) Dannon (Tarrytown, NY)
L. reuteri RC-14™ L. rhamnosus GR-1™	Femdophilus®	Chr. Hansens (Milwaukee WI) Urex Biotech (London, Ontario, Canada) Jarrow Formulas (Los Angeles, CA)
L. johnsonii Lj-1 (same as NCC533 and formerly L. acidophilus La-1)	LC1®	Nestlé (Lausanne, Switzerland)
L. plantarum 299V L. rhamnosus 271	Sold as ingredient	Probi AB (Lund, Sweden)
L. reuteri ATCC 55730 ("Protectis")	Stonyfield Farms yogurts	Biogaia (Stockholm, Sweden)
L. rhamnosus GG ("LGG")	Culturelle®; Dannon Danimals®	Valio Dairy (Helsinki, Finland)
L. rhamnosus LB21 Lactococcus lactis L1A	Sold as ingredient	Essum AB (Umeå, Sweden)
L. salivarius UCC118		University College (Cork, Ireland)
B. longum BB536	Sold as ingredient	Morinaga Milk Industry Co., Ltd. (Zama-City, Japan)
L. acidophilus LB	Sold as ingredient	Lacteol Laboratory (Houdan, France)
L. paracasei F19	Sold as ingredient	Medipharm (Des Moines, Iowa)
L. paracasei LP-33	Sold as Ingredient	GenMont Biotech (Taiwan)

To have a strain added to this table, please contact mes@mesanders.com with information on the strain to justify its inclusion and a contact person.

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Probiotics are available in the United States in foods, dietary supplements and medical foods. There are no drugs approved for human use in the United States. In recent months, the diversity of food products containing probiotics has expanded considerably. The table below links some commercial products to the types of health benefits that have been studied for the products or the strains contained in the products. Not all products, even those claiming to be "probiotic" deliver adequate levels of probiotic microbes that have been documented to have health benefits.

All yogurts sold in the United States are made with the yogurt starter bacteria (S. thermophilus and L. bulgaricus). As long as a yogurt is not heat treated after fermentation, the yogurt should contain high numbers of both of these bacteria. This is the situation with all yogurts that display the Live Active Culture Seal (a program administered by the National Yogurt Association, see www.aboutyogurt.com). Most of these yogurts also carry additional bacteria added for their health effects. Unfortunately, these additional bacteria may not have been studied for their specific health effects or they might not be added to the yogurt in high enough levels to be efficacious. No yogurts currently display the levels of bacteria present in the final product, so the only way to know if a yogurt carries enough of the right type of probiotics to be beneficial is to contact the manufacturer. The Live Active Culture Seal does not specifically address levels of probiotic bacteria in a product so it is possible for a yogurt to meet the criteria for carrying the seal based on high levels of starter bacteria but still have low levels of probiotics bacteria. As such, the LAC seal is not a reliable indicator of high levels of additional probiotic bacteria in yogurt.

The table below lists some commercial probiotic products available in the United States. This table focuses on products containing probiotics that have been shown to have health benefits. More diverse product offerings are available in other countries worldwide. Some description of products follows.

Dannon offers three fresh dairy probiotic products: Activia, a probiotic yogurt with a strain of Bifidobacterium animalis DN173010, DanActive, a fermented milk containing Lactobacillus casei DN-114 001 and Danimals, a yogurt marketed to children containing L. rhamnosus GG. Benefits are listed in the table below.

Stonyfield Farms adds six species of bacteria to all of its yogurt products. The yogurt starter culture bacteria, Streptococcus thermophilus and Lactobacillus bulgaricus, are present along with unspecified strains of Bifidobacterium species, Lactobacillus casei, Lactobacillus acidophilus and Lactobacillus reuteri. Stonyfield Farms yogurts also contain inulin.

Attune Foods recently introduced both chocolate bars and granola bars containing "over 5 times the live active cultures as yogurt". Three strains Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium lactis are included in these products at 10¹⁰cfu/bar until the end of room temperature shelf life. This is a unique offering in the market in the United States and provides a convenient format for a food containing live active cultures. Contact the manufacturer for details on health benefits.

Naked Juice has introduced a 100% juice smoothie containing 5x10⁹ cfu B. lactis HN019. This strain has been shown to improve immune function in healthy individuals, primarily elderly populations.

Lifeway Foods, the largest seller of the kefir in the United States markets Basics Plus® kefir containing six live, active cultures and a yeast. No studies have been published documenting the specific health effects due to the microbial content of this product.

Horizon Organic Dairy includes Lactobacillus acidophilus and Bifidobacterium in all its yogurt and cottage cheese products.

Kashi has launched a probiotic-containing cereal called "Vive". In addition to 10⁹ cfu/serving of L. acidophilus LA14, it also contains several other functional food ingredients: a "small amount" of ginger, 12 g. fiber, concentrated broccoli extract equivalent to ½ c. broccoli, and 20% DV calcium and vitamin D. The probiotics are "microencapsulated" nuggets. Kashi communicates general benefits of probiotics, but does not describe specific benefits that have been established for strain LA14 at the levels in this product.

Some milk products also contain probiotics. These unfermented, culture-containing milks taste the same as regular milk, but contain ~2 million Lactobacillus acidophilus bacteria per ml, or ~500 million in an 8 oz. glass. Some also contain bifidobacteria. Many different dairies across the United States sell these milks. Contact the manufacturer to determine what benefits, if any, can be attributed to the bacteria added to these products at these levels.

More than 100 companies in the United States market probiotic products in supplement form. A few of these are listed in the table below. Many of the products currently on the market are not clearly tied to research documenting beneficial effects. Contact individual manufacturers to determine what is known about health benefits.

 

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