Are Probiotics Properly Regulated?
May 04, 2015
Recently, we have been paying close attention to, and writing about, the actions taken by Eric Schneiderman, the New York State Attorney General in regard to nutritional supplements that were found not to contain the ingredients stated on the labels – read our take on it here, and another similar study here.
Unfortunately, the problem is systemic due to under-regulation. The FDA does not regulate supplements (including probiotics) as drugs, so they are not subject to the same level of scrutiny and consumer protection. Sure, there are limits to the health claims that these products can make, but industry oversight is lacking, and there are few checks and balances in the system that ensure the consumer is getting the health benefits that they are paying for.
Those that know Natren are already aware that we take a highly scientific and verifiable approach to developing and manufacturing probiotics. Natren has been complying to voluntary, internationally recognized standards, such as those created by the Swiss Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) and audited by Australia’s rigorous Therapeutic Goods Administration (TGA), and we have been a long-time advocate of adopting these standards for the broader industry.
In a recent development, we have heard positive comments from the FDA in this area. As reported by the industry publication NutraIngredients, the acting Director of the FDA Dietary Supplement Division, Dr. Cara Welch, was reported as saying “We know there is a GMP [Good Manufacturing Practices] problem out in the industry. So in that respect we are very interested in every aspect of cleaning up the industry, whether it is from industry self-regulation, whether that is from the states themselves or whether that is from FDA”.
Dr. Welch went on to highlight that “Firms aren’t testing the raw materials when they come into their facility, they have no control procedures written down for controlling the product as it makes its way through the facility, and they don’t know what kind of product they are making if they have no specifications. That’s concerning to us, and it should be concerning to industry as well”. We wholeheartedly concur with this sentiment, and we encourage the supplement industry to clean up its act with quality control, auditing, and compliance with internationally recognized standards such as those mentioned above.
Forced compliance may actually happen sooner, rather than later. Hot on the heels of the action initiated by New York, a group of 14 state Attorneys General have asked the US Congress to investigate the industry, specifically the contents and safety of herbal supplements, and also to consider giving the FDA more oversight of these products.
It is not clear how effective this request will be in increasing the regulation in the industry – however in our opinion, this can only be a good thing for two reasons:
- Regulating the presence and effectiveness of key ingredients, especially if they apply to living cells such as bacteria in probiotics, would be welcome for consumer protection and for cleaning up an industry that has become populated with snake-oil salesmen.
- The threat of legislative regulation of an industry often has the effect of spurring voluntary action from the manufacturers themselves.
At Natren, we have shown that voluntarily stepping up and complying to a higher standard not only makes for a better product, but also builds consumer trust and brand loyalty. We hope that other brands will join us in this approach – a cleaner industry with greater consumer confidence helps all of us.
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