Worries about dietary supplements over the past couple of years have thrown a shadow over the supplement industry as a whole, and many consumers find themselves wondering if they are really getting what they’re paying for when they purchase supplements. Is there cause for concern?
The Dietary Supplement Health and Education Act of 1994 includes regulations concerning the manufacturing and sale of supplements, giving the FDA the ability to regulate product labeling and setting standards for Good Manufacturing Processes (GMP). The problem is that manufacturers and distributors are responsible for ensuring and evaluating the safety of their own products, so companies are largely on the honor system when it comes to meeting DSHEA requirements.
What does this mean? You as a consumer need to do your own research when choosing which companies to buy your supplements from.
The good news is that the FDA is beefing up its ability to test and regulate probiotic ingredients. FDA’s GutProbe is a DNA microarray that can identify probiotics and microbials in dietary supplements1. The GutProbe can even identify specific strains in multi-strain probiotic supplements to ensure that manufacturers are following GMP regulations.
This, along with the FDA’s development of a probiotic genome database, will give consumers more confidence that their probiotic supplements match their claims.
We talked to Jamie Morea, Co-founder of Hyperbiotics, to get her advice on how to trust your supplement
Why is there so much mistrust within the supplement industry?
The reason is twofold:
1. The industry is mostly self-regulated and numerous companies offer products that simply are not what they say they are—this could be intentional or unintentional. Without strict internal quality control and thorough testing of each ingredient, a company may even unintentionally manufacture a product that does not meet label claims or comply with the FDA’s guidelines.
2. Negative articles in various media sources have misled consumers into mistrusting the supplement industry as a whole. For example, the New York Attorney General recently went after the highly regarded supplement retailer GNC because one of the products sold in their stores did not meet label claims after testing. Unfortunately, the testing methods were incorrect and GNC went to great lengths to let the Attorney General’s office know that they had used improper testing procedures, which is why the product failed their tests. Of course, the initial article regarding the failed test appeared on page one of the New York Times, but the retraction appeared on the back page of an issue about a week later. Unfortunately, many consumers never read the real story behind this major mistake.
How can a consumer be confident in the supplements they choose?
Consumers need to thoroughly research the supplement company to ensure their products are manufactured in the United States under GMP regulations.
GMP regulations state that manufacturers must hire qualified employees; design their plant to protect ingredients; use appropriate equipment; establish procedures and records; identify ingredients and purity; label and store supplements correctly; and keep a record of complaints.
What steps does Hyperbiotics take to ensure their formulas are safe, survivable, and meet label claims?
We use five different specialty labs that test for an array of items including CFU count, strain/ingredient identity, and the presence of allergens, among other things. A third party laboratory tests each and every ingredient used in Hyperbiotics formulations for identity when it reaches the manufacturing facility. This ensures that the ingredient has been 100% cross-identified to match the ingredient supplier’s specifications.
In addition, we test each and every ingredient for the presence of allergens and metals as well as potency to ensure that it meets the manufacturer’s claim. The probiotic strains in all Hyperbiotics formulas have been rDNA genome sequenced to make sure they match their proper genus/species identity. We also test the CFU potency of the probiotic product at three different times during the manufacturing process before it is finally packaged and labeled.
Should consumers be wary of probiotics that are genetically modified?
Although this is a matter of opinion—and many companies disagree—at Hyperbiotics, our manufacturing facility will not allow the presence of GMO probiotic strains. Some people are okay with eating corn that has been genetically modified and some are not. I would assume that these same people would most likely feel the same way about any genetically modified probiotic strains.
We have trillions of bacteria in our intestinal tract that have come from a wide variety of sources and the need to introduce genetically modified bacteria into our digestive systems is certainly not something that scientists have yet to recommend as an advisable practice for good health.
At Hyperbiotics, we're proud to create formulas that continue to meet and exceed our customers’ highest standards by going well above the FDA requirements and GMP standards.
What do you think about additives and colorants in supplements?
Unfortunately, many supplements contain unnecessary additives that can actually be harmful to your health. Some supplement manufacturers use fillers, binding agents, coatings, sweeteners, coloring agents, flavors, preservatives, and emulsifiers that have no benefit to your body, and could even cause health issues.
For example, many dietary supplements, especially those marketed to children, contain alarming amounts of sugar and artificial dyes to make them more “appealing,” with little to no regard for how these affect our kids’ health. Some ingredients, like Red Dye No. 4, are even banned in other countries but still appear frequently in supplements in the United States. Another common colorant, titanium dioxide (used to make tablets white), can cause nerve and brain issues.
With Hyperbiotics probiotic formulas, you can rest assured that you are getting all of the good stuff with none of the bad. Our products are free of sugar, chemical colors, soy, gluten, lactose, artificial flavors, and preservatives.
Is the "milk test" an accurate way to determine if a probiotic is alive and survivable?
There is information floating around online claiming that you can determine if the probiotics in your supplement are alive by placing them in milk and seeing if it curdles. As it turns out, this is another example of why you can’t trust everything you read on the Internet!
The reason that this test is not a viable way to test your probiotic supplement is that most probiotic strains do not grow well in milk or produce enough acid to curdle the milk (which is what dairy starter cultures do during the manufacture of cheese and yogurt). You see, dairy starter cultures contain high amounts of bacteria from the genus Lactococcus (a type of streptococcus), which can grow in milk because they can breakdown and metabolize the peptides contained in milk. On the contrary, our probiotic formulas contain bacteria from the genus Lactobacillus and Bifidobacterium, which do not grow well in milk by themselves because they cannot break down and metabolize the milk peptides very well.
Out of curiosity, and because this concept has gained popularity recently on certain websites, our facility has actually lab tested using this milk test and the results were inaccurate when compared to our other, professional viability testing methods. In order to prove there are live organisms, a lab must test via specific lab procedures, which can rarely be performed in a home environment.
As another note, when you place one of our tablets in milk, you should see a gel matrix form around the outside. This is because of the BIO-tract® delivery method that allows the live bacteria to gradually release from the pearl's core over an 8-10 hour period. Because of BIO-tract®, the beneficial bacteria are able to survive past the harsh environment of your stomach (thanks to the aforementioned gel matrix) and release the bacteria slowly as they make their way to your lower intestine—where you need them most.
For detailed information on our formulas and a closer look into why we believe Hyperbiotics probiotics are the safest and most survivable in the industry, visit our products page.References:
1. Patro, J., Ramachandran, P., Lewis, J., Mammel, M., Barnaba, T., Pfeiler, E., & Elkins, C. (2015). Development and utility of the FDA ‘GutProbe’ DNA microarray for identification, genotyping and metagenomic analysis of commercially available probiotics. Journal of Applied Microbiology, 118(6), 1478-1488.
Written by Jamie Morea, Gut Health Evangelist, Mama Bird & Co-founder of Hyperbiotics. For more ideas on how you can maximize wellness and benefit from the power of probiotics, be sure to subscribe to our newsletter.