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May 2008

Product Reviews / NutriNibbles

Probiotic Foods: 2008 Update

Part VIII: Nutraceuticals & Supplements


This is Part VIII of a ten-part article. Use the article index below to click among the pages. In this section, we take a look at brands of nutraceuticals and supplements that have probiotic, prebiotic and/or synbiotic benefits.




Nutraceuticals & Supplements

Overview & Issues

When I wrote last year’s article, I was amazed at the number of probiotic nutraceuticals and supplements available. This year, there seems to be an even greater number of them. More astonishing still is the fact that some of these products are actively being marketed for children—in some cases, even young children.

I can see the potential for profit in such marketing. Most people would agree that at least some of one’s health is based on diet. Has there ever been a kid who voluntarily consumed well-balanced meals on a steady basis? And children, especially younger children, don’t necessarily have the strongest immune systems in the first place. Reading the descriptions of these supplements, you’d assume they’ll give your child’s immune system a boost. What caring, responsible parents want to think they haven’t done everything possible to ensure their child’s well-being?

But in a society notorious for its consumption of pills and tablets, I have to wonder how valuable nutraceuticals and supplements will turn out to be in long-term analysis, for either kids or adults. Does it make sense to take one or several probiotics that are not necessarily part of a food system, especially if they’re in high concentrations? Might there be any long-term effects from this “more is better” approach? While eating a variety of probiotic-containing foods should lead to a spectrum of friendly bacteria in your gut, how do you know which supplements to take, given that there’s no one ideal set of intestinal microflora for everyone? Should you take several of these supplements, perhaps? No one has all the answers, and that should make you stop and think before ingesting any type of supplement.

One of the biggest problems with dietary supplements of any type is that their producers often claim product benefits that are little short of life-changing. According to a CAST Issue Paper (Number 36, October 2007) entitled “Probiotics: Their Potential to Impact Human Health,” contrary to popular belief, supplements must meet some standards. Although supplements do not have to gain pre-market approval, as do drugs, it is illegal for any manufacturer to produce a supplement (or food) that is unsafe. But currently, for supplements, the obligation of assuring safety rests with the manufacturer, not with the FDA. With drugs, it’s possible to make a determination of risks vs. benefits, something that can’t be done for supplements (or foods).

Probiotic Supplement Claims

Within the U.S., supplements cannot claim to diagnose, treat, palliate, cure or prevent any disease. That’s why you see disclaimers to this effect on so many supplement websites. What supplement producers can do is make health claims for their products, if these claims are FDA-approved (that is, they are allowed to state “the effect of a dietary substance on the reduction of risk of disease by the currently healthy population”). These claims may be qualified or unqualified. Supplement manufacturers can also make what’s called a “structure function claim,” which describes the effect of a substance on the body’s structure or function, if:

  • The claim is truthful and doesn’t mislead people
  • The manufacturer notifies the FDA of its intent to use this claim within 60 days of marketing the product
  • The product’s label includes the wording, “this statement has not been reviewed by the FDA”

Surely those are sufficient safeguards against any blatantly false claims? Not so much, it turns out. Oddly enough, a major sticking point is the set of FDA priorities. Above all else, that agency has to be concerned with safety, including any use of untested or unsafe ingredients, and quashing statements from producers who are mislabeling their supplements as drugs (products that can treat, cure or prevent diseases).

With all of the foods and drugs manufactured in the U.S., or imported into this country, that’s an enormous task. It’s far likelier that a manufacturer would be sent a warning letter for an unsafe supplement than for one that promised something it couldn’t deliver. I’m not saying that all probiotic supplements are completely ineffective, nor am I condemning the FDA for the order of their priorities. But the adage, “caveat emptor,” should be considered frequently. If a supplement’s claims seem larger than life and too good to be true, there may be a reason. And, according to information on the U.S. Probiotics website, many probiotic supplements (this applies to foods, too) simply do not meet their label claims for content—in terms of identity, purity and strength of probiotic strains.  

Hopefully, this situation will begin to change over the next few years. In mid-2007, the FDA announced a ruling on current good manufacturing practices (cGMP) for dietary supplements (this ruling applies to supplements only, not food). Through June 2010, requirements will be phased in regarding evaluation of identity, purity, strength and composition of supplements. The idea is to prevent contaminants, inclusion of incorrect ingredients, too much or too little of an ingredient and improper packaging and labeling. Also included are requirements for record-keeping and handling consumer complaints. This still does not address the issue of whether or not a supplement is effective, but it’s a step in the right direction.


Probiotic Capsule & Powder Supplements

Here is a sampling that represents just a fraction of the plethora of supplements you’ll find online and in stores. I sought the opinion of Mary Ellen Sanders, PhD and an expert on probiotics, on some of these claims.

Align. Procter & Gamble has introduced Align, specifically targeted toward Americans with irritable bowel syndrome (IBS). This is a once-daily capsule containing the probiotic Bifidobacterium infantis 35624, called “Bifantis” by the manufacturer. With continued daily intake, Bifantis is said to be “a unique probiotic strain that has been clinically proven to build and maintain a strong, healthy digestive system.” There is some clinical research to back up this claim. The manufacturer cites a study of 362 women, ages 18 to 65, who had been diagnosed with IBS. The women given Bifantis fared significantly better in the reduction of symptoms than those given a placebo. But the period of study was only four weeks, and the study itself was sponsored by the Procter & Gamble Health Sciences Institute. A smaller study (77 patients), but one of eight weeks’ duration, found that patients given Bifantis experienced reduction in several common IBS symptoms, such as abdominal pain/discomfort, bloating/distension and bowel movement difficulty.

Theralac. Therabiotics, producer and seller of Theralac Probiotic Master Supplement, has adopted Theralaca hard-sell approach. According to the company’s website, “Probiotics help restore regularity fast provided they contain at least 10 billion CFU/dose and are composed of multiple strains of Lactobacillus and Bifidobacteria in a formulation that assures LIVE DELIVERY into the intestinal tract.” Dr. Sanders maintains that no general guidelines for type, quantity or delivery system of probiotics that would restore regularity have ever been established, nor is there evidence that a mix of strains are inherently better at this than is any single strain. Theralac does have quite a number of clinical trials on its website as scientific back-up for its claims; yet very few of these studies seem to have anything to do with frequency, consistency or predictability of bowel movements. Effective consumption levels, Dr. Sanders comments, vary for strains as well as products tested. Recommendations must be based on human studies on specific products.

iFlora. Supplements for women’s health, nasal health and kids, as well as two types of a 16-strain supplement, are produced by Sedona Labs, under the iFlora label. The most iFlora Nasal Healthinteresting to me was the supplement for nasal health. According to the website, “Swiss researchers discovered that this specific probiotic formula…maintains healthy levels of flora in nasal sinuses.” Dr. Sanders indicates that she is aware of only one study on nasal microflora. That study, published in the American Journal of Clinical Nutrition in 2003, did conclude that regular intake of probiotics can reduce certain pathogenic bacteria in the upper respiratory tract. But the study examined only microflora in the nose itself, not in the sinuses. Further, the probiotics in this study were in a fermented milk drink, not in capsule form. I e-mailed the company to request information from specific studies pertaining to this claim. Despite assurances on their “contact us” form that they would reply within two business days, I received no answer.

Baby’s Only. Nature’s One, the makers of Baby’s Only Essentials Probiotic Supplement stipulate that parents should consult healthcare professionals before giving any probiotic product to a child less than one year of age. On the other hand, Baby's Onlythis is a perfect example of probiotics marketing that targets young children. The manufacturers state that “A baby’s first ingestion of friendly digestive bacteria occurs naturally while passing through the birth canal” and that “An infant continues to be exposed to beneficial bacteria through breastfeeding.” The company then qualifies those statements with, “At times, a baby may need assistance in maintaining friendly bacteria.” Again, I believe that a statement like this plays on parents’ fears. How would you know when your baby needed help in maintaining his or her probiotic level? Wouldn’t you think that a probiotic supplement was a way to be certain of it? At the present time, though, Dr. Sanders notes that ideal levels of bacteria such as Lactobacillus or Bifidobacterium within the intestinal tract simply are not known, so there can be no certainty in this area. This supplement is sold in powder form; it is a synbiotic, as it contains fructooligosaccharides as well as three species of Bifidobacterium: B. infantis, B. longum and B. breve.


Probiotic Liquid Supplements

Body Ecology Diet. The Body Ecology Diet has not one but three probiotic beverages. Coco-Biotic contains the liquid of young coconuts, Dong Quai contains probiotics as well as the herb of the same name, and Innergy Biotic is a “gluten-free, energy-boosting, probiotic liquid.” Each beverage has a two-ounce serving size. While they vary in the level of probiotics per serving, all contain the same four probiotics: two strains of Lactobacillus and two of Saccaromyces. I have seldom seen so much hype crammed into a mere three web pages. For example, take Coco-Biotic. This beverage is billed as “An amazing breakthrough that will conveniently and economically help balance your inner ecosystem.” It is “A naturally-fermented drink made from wild-crafted, young green a savvy blend of synergistic probiotics.”

One must be careful in purchasing probiotics, it seems, because the bacteria they include “may not be natural to the human GI tract, or even compatible with each Body Ecology - Innergyother.” But Coco-Biotic and its ilk are “…a smart blend of beneficial bacteria and yeast specifically chosen to work in a symbiotic or mutually beneficial way.” Dr. Sanders explains that, while some probiotics are not “native” to humans, that doesn’t mean anything. As she succinctly puts it, “If they work, they work, and it shouldn’t matter where they were isolated.” Into this “non-native” category fall strains such as  Saccharomyces boulardii and all B. lactis and B. animalis strains. As far as a food source for these probiotics, “With Coco-Biotic, you don’t need to worry about buying additional pre-biotic supplements. That’s because Coco-Biotic contains the beneficial enzyme-producing yeasts that friendly bacteria love to feed on. Plus, it contains healthy fermented grains, which provide natural food for the probiotic bacteria. Not only that, but the friendly bacteria also feed on the natural sugars from the young coconut water.” Dr. Sanders advises, however, that she is unaware of any evidence that would substantiate this statement. She points out that “the intestinal milieu provides ‘food’ for probiotics” and that claims such as these require data to demonstrate that probiotic populations are increased via consumption of this product. There is no such data anywhere on the site.

If you do a little digging on this website, you discover that these products are manufactured by Grainfields Australia, the Pacific Rim division of the folks who make the tropical fish probiotic supplement described in the Pet Probiotics section below.

Yakult. Probiotic dairy-based drink Yakult, developed in 1935 by a Japanese microbiologist, is slowly expanding its distribution within the U.S. Availability in many regions of the country is primarily at Asian and Hispanic markets, except in California Yakultand Nevada, where the product can be found in such establishments as well as a number of grocery stores. According to the Yakult USA website, more than 25 million people drink Yakult on a daily basis. One small bottle of this cultured dairy drink (65 ml, about 2.2 ounces) “…contains more than 8 billion Lactobacillus casei Shirota—the ‘friendly bacteria’ that help balance your digestive system and support immune functioning. L. casei Shirota can ONLY be found in Yakult [Shirota was the microbiologist inventor) and when consumed in sufficient quantities, this probiotic strain can be very beneficial for you.” 

Doc’s Friendly Flora Enhanced Microbial Liquid Probiotics. A more comprehensive set of benefits from ingesting probiotics is suggested by Dr. Ron’s Ultra-Pure, producers of Doc’s Friendly Flora Enhanced Microbial Liquid Probiotics. According to the company’s website, this product contains a number of different probiotic strains as well as a phototropic (capable of deriving energy from light) microbe and “has a marked detoxification effect, which helps explain its wide range of benefits.” Next to a photo of the bottle of this supplement, in bold type, are the words “detoxify,” “lose weight,” “feel great”; it’s even said on the product page that “Enhanced well-being may benefit those affected by autism, ADHD and cognitive disorders.” I have no reason to doubt the latter statement, but it would apply regardless of the source of the enhanced well-being.

Dr. Sanders tells me that she has seen no data on weight loss or “feeling great” (in general) through probiotics. She adds that there is some information on some strains for “detoxification” activities of some probiotic strains, but she doesn’t know if there are any data from human studies on this specific product. No such information is provided on the site. There’s something else curious about this formula. The website proclaims that this liquid contains “one million colony-forming units per ml.” As was pointed out in earlier sections of this article, in the world of probiotics, that’s an incredibly low number. Recall that to carry the National Yogurt Association’s “Live & Active Cultures” seal, refrigerated yogurts must have a minimum of 100 million cultures per gram (a gram is approximately equivalent to a milliliter) at the time of manufacture. Even frozen yogurts must have 10 million cultures per gram at time of manufacture to qualify for this seal. Most scientific studies I’ve come across discuss CFU’s in the billions as routine quantities. Again, there’s no scientific data on-site to support use of this level of probiotics. Dr. Ron is Dr. Ron Schmid, a naturopathic physician, who runs an alternative medicine center in Connecticut. Other products on offer here include grass fed freeze-dried organs and glands (imported from New Zealand and billed as “traditional superfoods”).  

Colostrum. For those of you unfamiliar with colostrum, it is a mammary secretion produced only at the very beginning of the lactation cycle. Why is colostrum important? According to the Colostrum Center, it contains, among other beneficial things, vitamins, minerals, enzymes, immunoglobulins and amino acids. Colostrum also contains a variety of probiotics, including some strains of Lactobacillus and Bifidobacterium. The Colostrum Center website declares that bovine colostrum is almost identical to that produced by humans. While I was able to find some research indicating that colostrum is beneficial for newborn livestock, I found only one study documenting any beneficial effect on humans. This study had no date attached to it (although none of the supporting research was more recent than 2001), and was on a website belonging to a company that sells colostrum as a supplement (see more here). Nonetheless, some people take bovine colostrum as a dietary supplement. Organic Pastures, in California, sells raw colostrum, two variants of that product (one chocolate-flavored, believe it or not), and a near-kefir called Qephor, that is their Superleche Lite Colostrum cultured with kefir grains. They ship nationwide.


Probiotics For Pets

Given the number of cats and dogs and other animal family members with sensitive stomachs, probiotics for pets is no joke. A handful of companies produce various formulations for cats, dogs or both, including the pet food giant Purina.

  • Purina’s FortiFlora, a probiotic nutritional supplement, is offered in different Purinaformulations for cats and dogs, and is suggested for the “dietary management” of those animals suffering from diarrhea.
  • Natur’s Way manufactures probiotic supplements “formulated to work directly with your pet’s digestive system to strengthen natural processes and aid recovery from stress, illness, or trauma”; it also sells microbial preparations for livestock.
  • Grainfields USA, the American division of an Australian company, offers “Pet Pep Up,” a probiotic supplement for any tropical fish near and dear to your heart. Supposedly, this powder “will not only restore and maintain the digestive health of the fish but also help to keep the water clean in the tank.”

I asked a vet about the usefulness of any of these supplements. Her reply was that she knew probiotics had been used successfully to treat diarrhea in dogs and cats, but she was not aware of sufficient other research to enable her to recommend any kind of daily probiotic supplement for household pets. She added that people wishing to give their pets such supplements should discuss the matter with their veterinarians and look for a well-established manufacturer with a good reputation.


Continue to Part IX, Probiotic Health Claims

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