Truth in Labeling: Regulation of Probiotics – Part 2
May 09, 2014
[If you are looking for Part 1 of this story, you can find it here]
Did you know that you can launch your own probiotic product line with no scientific experience whatsoever? No measurement of effectiveness, no study of how the bacteria interact with each other, and no study of potency through to consumption by the consumer. Well, you can, and we’ll show you exactly how to do it:
1) Secure sufficient funding to place a commercial sized order
2) Gather a marketing team to create tantalizing taglines like “Now with 20 probiotic strains to boost your digestive health”
3) Engage with a contract manufacturer to create a fully bottled and labeled product to your marketing specification. Examples are here, and at http://www.nutricaplabs.com/probiotic-manufacturer.aspx.
4) Create an online store advertising unproven benefits and sell direct to the high street, with full confidence that there is no one with the authority to verify your claims, or stop you from cheating your customers.
Sound fair? We don’t think so either. Actually, neither do the authorities in the European Union (EU), who are clamping down, even banning the word “probiotic”, saying it implies an unproven health claim.
However, what happened in the EU is a very dangerous precedent because the EU has taken off the shelves any probiotic product that combines the word ‘probiotic’ and any health claim. It is probable that the poor quality of some products led to this reaction, which is also conveniently aligned with the interests of “Big Pharma”, who have a lot to lose from the expansion of more natural, non-chemical health solutions, and has caused the bureaucrats to clamp down on all players, good and bad. Close to 300 clinical trials were submitted but all were denied – which suggests that something is not right.
It would be a travesty if the same thing were to happen in the US. We need the FDA to look at the two standards that were written by Natasha Trenev, Founder & president of Natren Probiotics. These standards were voted on by the entire Health Food Store community, stores, distributors, manufactures and brokers. That standard was actually read into congressional record and should have a voluntary program administered by the NPA under a true label program. The consumers and retail stores should not buy or sell any products that do not adhere to the standard. The true label program failed under the supervision of the NNFA (now) the NPA because the stores did not demand the probiotic products conform to the standard.
There is clearly a gap in the regulation of these beneficial bacteria. There have been countless scientific studies demonstrating the benefits of probiotics for a variety of different conditions, but it has also been found that packing many bacterial strains together is counterproductive (bacteria are naturally competitive, and will fight and kill each other if incorrectly delivered). To quote a senior executive at one of the worlds largest ingredient manufacturers: “…if a formulation has 12 strains in it, let’s face it, a number of them are in there for marketing”.
We believe the end result is consumer fraud, as the consumer has no way of knowing if they are buying a ‘good’ probiotic, or a ‘worthless’ probiotic. We are confident of the validity of our product here at Natren, and we go the extra mile to educate our customers on what to look for when choosing a probiotic and how to take care of their health (this blog being a prime example). However, there are sharks in the water, and there are too many examples out there of marketing companies creating a white-label probiotic concoction and passing it off as a beneficial health product. The consumer is being cheated, and they’re often unaware. We’d like to say that if there was the same criteria used to evaluate organic food as there are probiotic products, customers wouldn’t buy 90% of these so-called probiotic products that are on the shelves.
So our call here is to the FDA: Get involved and regulate this unruly marketplace. Just as the USDA has regulated the Organic Foods market and demanded proof and accountability of their methods and ingredients, require that probiotics manufacturers are accountable for the formulas, manufacture-to-retail chain of custody of the product (including environment conditions) and end-product viability of all the ingredients on the label. Consumers deserve that from their regulatory authorities.
Meanwhile, Consumers: Learn the difference between a good probiotic and a bad probiotic. There are plenty of resources in the blog section of our website, including our “Probiotic Buyers Guide”. That will help you understand products available from Natren, and will equip you with the right questions to ask competing brands.
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