TRUTH ABOUT PROBIOTICS

Food Contamination Concerns Part 2: Hot Delivery Trucks

A story recently aired on MSNBC regarding Indiana’s push for regulating safe temperatures in trucks transporting perishable foods to restaurants and grocery stores. In the midst of increasingly common national food recalls due to bacterial contamination- we see stark examples of how, many times, trucks transport perishable items without refrigeration. Sometimes the refrigeration units are broken, and sometimes they are even intentionally turned off to save fuel.

http://www.msnbc.msn.com/id/21134540/vp/44623239#44623239

The FDA outlines that foods must be transported at or below 41 degrees Fahrenheit to prevent growth of dangerous bacteria which can cause illness in humans- such as E. coli and salmonella. The problem is, there is very little policy to regulate shipping practices to protect the public. In 2005, Congress ordered the FDA to make rules to enforce shipping standards, but the FDA has yet to act. These examples illustrate an important point- we often limited by what we see and read to define “freshness” in foods we find in stores, and then rely upon the assumed good manufacturing processes of the facilities that make these foods. But in between, there lies a very real public danger that currently remains largely invisible to both the public and to the federal government. Even in Indiana, where there is now a state government push for road inspections, they can only inspect 1% of food trucks for proper handling!

This same logic also applies to probiotics. Probiotics are sensitive living cultures which require extra care to preserve their viability. This is why they must be shipped quickly, on cold packs or dry ice, when transported from one refrigerated facility to another. Check with your local health food store or product distributor to find out how it enforces proper shipping of probiotic products; if the product is refrigerated in the manufacturer’s warehouse and the distribution center, and on the way to store. Customers should also ask the store whether all products in the refrigerator were shipped to the store in a thermally controlled shipping container. Many times, the probiotics arrive in hot container, and the store simply then puts them into the refrigerator. We find this practice reprehensible and unacceptable.

FDA’s Food Safety Modernization Act (FSMA) was put in place to help strengthen the FDA’s ability to enforce food safety controls. The problem is, the FDA only oversees about 80% of our food, the USDA controls poultry, meat and egg products. Funding is another big problem for ensuring food safety, there is simply not enough to go around. FSMA exempts small food businesses, which helps the financial burden of regulating the larger producers, but also leaves open more risks.

As our food chain has become more global, we accelerate the ability for a contaminant to be spread across the US (and world) and sicken many, before we even realize that there is a problem. In the U.S., the CDC estimates that 48 million people get sick, 128,000 are hospitalized, and 3,000 people die each year from food-borne illnesses. Last June, Europe struggled with a wide-spread infection from a virulent form of E. coli which sickened over 2,000 and caused 20 deaths. Beans and sprouts from Egypt were the likely source, but there is still much that is unknown about the exact sources.

With an increasingly global supply chain, it is important to do what we can to protect ourselves from contaminants. Probiotics have shown to be effective in preventing infectious forms of diarrhea, and may stack up as another type of defense against potentially contaminated foods.

Acute upper respiratory tract infections (URTI’s) are the most common reason for medical care visits in the U.S. According to a Cochrane review, using probiotics as prophylactic medicine is associated with fewer colds (according to research by Bi Rong Dong, MD, or Sichuan University in China.) Another important factor is that probiotic use was also found to significantly limit the number of antibiotic prescriptions needed for those with URTI’s. (Even though antibiotics should never be used to treat colds, they are often prescribed when a person gets a subsequent bacterial infection resulting from the inflammatory consequences of a viral infection- such as ear, lung or sinus infections.)

Dong’s research pooled the results from 10 randomized controlled trials which included 3,451 study participants ranging in age from infants to adults in their forties, and involved taking probiotics preventatively for more than a week. Probiotic use reduced the number of participants who had at least one acute upper respiratory tract infection by 42%!

Researchers believe that probiotics may boost systemic activity of phagocytes (which are part of our first line of defense against infections) as well as increase gut wall integrity. Now that we know that some of the infectious agents which cause upper respiratory disease actually infect through the gut wall first, this theory makes sense.

So- in addition to getting enough sleep, employing good hygiene practices, and good nutrition, access to a good quality probiotic has been shown to help prevent colds.

We’ve discussed some of the ways to make sure that probiotic cultures are present and viable, now I’d like to discuss how they make it into the target part of the body- the intestines. Each probiotic encapsulation has 3 very important components for ensuring the active ingredients get where they are needed. Supposing that a product has any viable strains in at all (see my previous blogs) after manufacturing, the delivery system of a capsule is responsible for ensuring that the max number of probiotics will survive their journey past the acidic secretions of the stomach. In this blog, I’ll discuss the best delivery system.

The first component to discuss is the matrix which holds the probiotic strains. The most effective way to transport probiotic bacteria past the onslaught of acidic secretions in the stomach is through an oil matrix. The oil carries the probiotics safely into the small intestine, where bile emulsifies the oil and then releases the bacteria, and making sure those bacteria are resistant.

The best way to house the oil matrix is through a 2 piece hard gel cap system. A hard gel cap contains up to 50% less moisture than a soft shell, and a low moisture binding is essential for preserving the oil matrix within. Gelatin, an animal-sourced product, is the highest quality ingredient used in gel-caps to secure ingredients and keep moisture levels low.

Third, is the strains themselves. A careful probiotic supplement chooses particular strains of bacteria which are best at surviving the extreme changes in pH between the stomach and small intestine, in addition to each strain’s specific, desired function in the body.

Some companies also offer vegan and/or powdered probiotic alternatives to match customer needs, but one needs to be especially careful in their choices within these categories. There can be large trade-off’s in shelf-life stability and number of viable strains with either of these methods, depending upon the manufacturing process. We’ll discuss what to specifically look for when shopping for a vegan and/or a powder-based product within the next couple of weeks of blog postings- stay tuned.

A recent environmental health article posted in a peer-reviewed journal (see the following link)

http://ehp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.119-a340

explored the link between specific types of friendly bacterial communities, or microbiomes, in the intestinal tract and how these communities changed the potential toxicity of heavy metals encountered in the environment.

There are microbiomes specific to all areas of the body that have contact with the outside world: the intestines, lungs, mouth, nose and throat, vagina, hair and skin. These environments are influenced by genetics, by birth (vaginal versus caesarean delivery), antibiotics, diet, and other environmental forces. While we have known for some time that the bacteria specific to the intestines have a role in nutrition (for instance, in producing vitamin K), it turns out that they also produce an array of complex components affecting nutrition, detoxification of poisonous substances, and substances that act like neurotransmitters which affect the way we think and feel (see my recent blogs for more on this subject).

What came as a surprise in this research, according to Ellen Silbergeld of Johns Hopkins University Bloomberg School of Health, is that studies now suggest that, “…the role of commensal bacteria may equal or exceed that of genetic polymorphisms that regulate metal transformations within the body.” This means that gut ecology probably trumps genetic tendencies in a person’s ability to process heavy metals.

The role that microbiomes play in handling heavy metals means a lot in the way of how these metals affect our health. To a toxicologist, a contaminant breaches into the body only at the moment that it enters circulation, or into a cell or organ space. If bacteria in the gut can process a contaminant in a way as to make it less toxic, or less apt to be absorbed through the intestinal wall, this has obvious benefits to the host. Alternatively, colonization with the wrong kind of bacteria may cause processing to even more hazardous forms of heavy metals. This might help explain why 10 people exposed to the same environmental/dietary levels and types of metals such as arsenic and mercury, are affected very differently. What happens when there is a loss (or initial absence) of beneficial ecology in infancy and childhood, when exposure to these contaminants can have the greatest effect on learning and behavior?

There has been a rise in probiotic products which claim to contain many different strains of bacteria in the same formulation, or, an “alphabet soup” of bacteria. Some companies feel that offering a product that throws in everything but the kitchen sink will offer a competitive advantage in the market. As a result, there are now a couple of major manufacturers based outside of the U.S. who supply most of the companies marketing these products.  The problem is this: because of the expense to fully test the viability of each strain in these products, it is simply not done. Otherwise, the cost per capsule would be astronomical for the consumer. If you see a label with a laundry list of organisms, you can be sure that there has been no verification process for each strain’s existence, viability, or expiration date. And as I pointed out in one of my recent blogs- without a pharmaceutical level auditing process to assess the contents, there is also no way of knowing what harmful contaminants might also be in the mix.

When selecting a probiotic product, it is therefore best to choose one or a few carefully selected strains of bacteria (such as tried and true Lactobacillus acidophilus), each strain with its own clearly marked expiration date. This is how you know that its viability has been verified. This approach is similar to how one chooses an exercise or nutrition plan, it is best to select the simplest, verifiable approach that works best for you. The benefits of taking a certified probiotic are usually noticed within the first few days. Just like you shouldn’t buy processed food products that contain a long list of hard-to-read words in the ingredient list, use the same logic for dietary supplements. Don’t rely on alphabet soup.

This week’s Economist ran a fascinating article entitled, “Gut Instinct.”

http://www.economist.com/node/21528214

The article explores the research outlined in a paper published in the Proceedings of the National Academy of Sciences last week regarding the profound effects that beneficial gut bacteria have on the mind and behavior.

Mice were supplemented with a common lactobacillus strain of bacteria and were observed while they were put in new and stressful situations. Compared to controls, the supplemented mice exhibited significantly less stress, and demonstrated more confidence and signs of a positive mood when put to task.

This is one in a recent line of ground-breaking research connecting the communication between friendly organisms in the gut and the functions of the brain. One has to wonder how this might pertain to humans- we are at a point when more people than ever in the U.S. and around the world are given antibiotics and other medications that kill or marginalize friendly bacterial species in the gut. When this happens during the first two years of life while the immune system and brain of a child is still developing, the disturbances may be more pronounced and permanent. Could this be one of the reasons why depression, anxiety, and a host of other mood and mental disorders have become so prevalent today?

There is a (sometimes necessary) risk in using substances that alter one’s inner ecology, and the effects may be long standing and far reaching. Now is the time to consider the preventive role that probiotics can offer by re-establishing the friendly bacterial cultures in the gut that are altered by medications, by alcohol consumption, by stress and illness. Literally, food for thought.

This study was also described in a Science magazine online article last week, which you can find here:

http://news.sciencemag.org/sciencenow/2011/08/mind-altering-bugs.html?ref=hp

A pilot study performed by university researchers in Seattle illuminated something extraordinary. (You can find the entire journal article here: http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ijam/vol1n2/lacto.xml.) In the study, researchers examined 20 different brands of probiotic supplements from Seattle area stores to analyze reliability and safety. Supplements were cultured for viability, and then isolated microorganisms were identified by genus and species using DNA analysis. All findings were compared to stated claims on the respective supplement bottles from which samples were sourced. The unwelcome surprise was: only ONE product out of 20 tested contained isolated organisms identical to what was listed on the bottle.

Worse than that, 20% of the samples produced no growth at all when cultured, and 30% of them contained contaminant bacteria- some from potentially harmful organisms.  Though this was a small pilot, it illuminated a few very real concerns for consumers across the U.S. where these common products are distributed:

#1: The cultures listed on a bottle of probiotics may not actually be in the bottle. Since many people are referred to take probiotics to help correct specific health concerns based upon positive research for particular culture strains, this renders many products questionable or useless.

#2: The cultures listed on the bottle might be present, but there is often no guarantee that they are viable or potent. Again, this renders a product useless. This correlated most highly with the non-refrigerated products.

#3: The product may contain bacteria which can be harmful to human health. This is the most concerning of all- because not only is the product a waste of money, it may be harmful to one’s health.

This pilot study is a reminder of the importance of considering the safety of all health supplements, and especially of probiotics. This is a class of dietary aids which boasts much in the way of supportive studies and data reflecting its use and benefit to many common ills in the U.S. population. However, since our government does not classify them as pharmaceutical substances, their manufacturers are not held to the same standards of testing and product assurance when bringing these products to market. As I mentioned in my last 2 blog entries, this is why it is important to look for probiotic manufacturers who use auditing agencies, such as the Therapeutic Goods Administration (TGA) of Australia, to ensure that products meet rigorous standards to be considered certified by the International Drug GMP. This ensures that what you see listed on the bottle is what you get, in every batch. Anything less is playing Russian roulette with your health.

As mentioned in my last posting, dietary supplements in the U.S. had a voluntary compliance mandate overseen by the National Nutritional Foods Association (NNFA) to ensure that manufacturers meet certain truth in labeling requirements to belong to the True Label program.  They did not administer any form of oversight regarding GMP certification.  GMP certification means that a company has proper documentation on such details  as personnel, warehousing procedures, equipment, grounds maintenance, sanitation, quality of operations, and other processes.  With the recent FDA updates for a stricter certification process, many supplement manufacturers have failed at this level.  While compliance is voluntary for this certification, it is always in the best interest of a company to show its customers that its processes have been inspected and approved- for the health and safety of consumers.

With International Drug GMP, a company is audited to not only meet the documentation requirements for meeting standards in process, it must also show rigorous documentation that what is inside a pill or capsule matches exactly what is listed on the label. This is the difference between foods and medicines/supplements- a consumer cannot evaluate the contents in any way by simply looking at the product. Meeting all GMP requirements does nothing in the way of ensuring that a probiotic product contains any live bacterial strains at all, or what types are in it, or if there is any contamination by other harmful strains.

One example of a certifying entity to reach the International Drug GMP standards is the Therapeutic Goods Administration of Australia (TGA), one of the strictest auditing entities. It requires mandatory, annual or biannual re-certification, and annual on-site inspections (domestic GMP requirements do not necessarily require any on-site inspections, and they only need to be re-certified every 3 years!)

When it comes to product control- the TGA audit process gives much attention to product specifications; this includes: product uniformity, homogeniety, product ingredient release and estimation of shelf life. It also ensures that a company routinely tests each batch of end products, as well as at other points during production, and clearly specifies relevant production conditions for a particular product. The Therapeutic Goods Act of 1989 also requires that an expiration date reflects valid stability studies conducted on the goods. In the case of probiotic products, this should mean an expiration date for each strain of bacteria listed on the label.

When it comes to supplement safety and efficacy, as well as knowing exactly what is in a pill or capsule (and resting assure that there are no contaminants), it is essential to choose probiotic products that meet International Drug GMP requirements.

The certificate requirements used to ensure Good Manufacturing Practice (GMP) of supplement manufacturers vary greatly by entity. Most supplement manufacturers in the U.S. choose to work with an entity which performs a system-type audit.  Unfortunately, the scope and depth of this type of audit varies greatly with the individual auditor, and many auditors do not have expertise in the stricter regulations recently introduced by the FDA. This is the one problem in backing up product guarantees.

The good news is that the FDA has taken the 3 major entities to task, and upgrades in at least one are taking place to make sure the critical areas in need of improvement have been adjusted. The new dietary supplement GMP’s are now more strict in their requirements of testing raw materials and finished products- which is why we have seen a stark increase in the number of critiques and warning letters sent to supplement makers in the past 2 years.

If a supplement company is dedicated and truly following these updated GMP’s regulations, it will be operating close to pharmaceutical grade standards, but still lacking the rigorous and strict process validation requirements. And therein lies the loophole; in the U.S., dietary supplements are classified as food products under the Dietary Supplement Health and Education Act (DSHEA). Because dietary supplements are not required to be effective as a drug, it means that product makers do not have to demonstrate process validation for submission requirements. This means that they do not have to prove that products are consistently the same from batch to batch. While this makes sense when the product is, say, a zucchini or a loaf of bread- there are problems when it comes to ensuring the number and viability of probiotic strains in a capsule matches the claims made on the bottle.

While GMP certification is a great starting point, it has no bearing on what the FDA might actually find during an inspection.  This is why companies who are committed to providing the most effective probiotics for substantial human health benefit seek out additional testing, at their own expense.

For instance, the highest level GMP that a dietary supplement maker can attain is the International Drug GMP for Medicinal Products. One way to gain this level is to receive a certificate of compliance from the Therapeutic Goods Administration of Australia. Australia’s TGA is the enforcement arm of an international manufacturing standard accepted by more than 27 countries in the world.  The original intent was to lower trade barriers between countries. Audits are intended to stop cheating and contamination by manufacturers.  Australia’s GMP Certificate of Compliance is very strict- it is actually more stringent than our National Nutritional Foods Association which gives certification to meet domestic GMP. How? It makes it mandatory to renew certification annually (instead of every 3 years) for all manufacturers of human health goods, requires a more detailed quality control system, extensive screening and continuous testing of every ingredient, as well as studies to back up stability claims for expiration date documentation.

The term “quality” is a vague term in how it relates to supplements.  Does lower quality convey that the consumer may not be getting what he/she is paying for? In my view quality means if you buy a lower quality car it still runs but may require more maintenance to meet its life expectancy whereas a low quality supplement may be lacking as much as 80% of the active ingredient.  How would you convey that using the word quality?