Compliance & Improving Quality
Jul 22 2021
| Our Blog
| Jacqueline Rizo
An interview with Nena Dockery, Scientific and Regulatory Manager at Stratum Nutrition
Nutrition Industry Executive recently asked industry experts to expand on how they see the industry’s vital signs today versus a year ago and what they think the industry’s prognosis is moving forward. Our Scientific and Regulatory Manager, Nena Dockery, was asked to join the panel of experts. Here’s what she had to say on “Compliance and Improving Quality.”
What are the biggest compliance challenges that the natural products industry faces right now, and what should be done to address them?
The COVID-19 pandemic resulted in considerable upheaval and uncertainty in all areas of life, and the Natural Products industry is no exception. Discretionary income dropped for many who had either lost their job or were temporarily furloughed. So, the demand for some types of dietary supplement products dropped substantially. On the other hand, ingredients and products marketed to support immune health and wellbeing has jumped dramatically, resulting in a regulatory nightmare. COVID treatments, preventatives and cures have popped up across the web. At the same time, products containing ingredients that have been researched for benefits to general immune health or specific to upper respiratory tract health are also more widely marketed. As a result, FDA and FTC is challenged with separating the good companies from the bad at a time when both manpower and funding are limited.
CBD continues to be a compliance challenge for the Natural Products industry. During the crest of the pandemic, most companies as well as the end-consumer were focused on immune support ingredients, so interest in CBD waned just a bit, but it hasn’t gone away. Though FDA has concluded that THC and CBD products are excluded from the definition of a dietary supplement, the agency is currently following risk-based enforcement discretion and products are continuing to be sold. (https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#:~:text=9.-,Can%20THC%20or%20CBD%20products%20be%20sold%20as%20dietary%20supplements,the%20FD%26C%20Act%20%5B21%20U.S.C.) Interest will probably begin to rebound in the very near future, and the compliance headaches will resume.
In more general terms, quality continues to be a big compliance challenge for the industry, and this is an area that directly affects the end-consumer. In a free-market society, there can be a fine line between the rights of the business owner and the interests of consumers who expect a certain level of safety and efficacy in the products they purchase.
The Natural Products Industry has done a reasonably good job at self-monitoring, but the sheer number of companies and products on the market make this almost impossible. It is a daunting task, but the best approach is probably to have more open communication between industry organizations and FDA/FTC with the goal of weeding out the companies that harm both the reputation of the industry and interests of consumers, while still allowing the consumer access to a broad range of natural health-supporting products.
Briefly comment on the current and predicted impact of Amazon’s sweeping new specs for dietary supplements — which require, among other things, a Letter of Guarantee from the brand owner of the product that guarantees compliance with CGMPs, assurances that the products only contain lawful and safe ingredients and that labels are accurate.
Amazon’s new requirements appear to be at least a step in the right direction. Products sold on Amazon as well as other online sites have long been vulnerable to adulteration and other business tactics practiced by less than reputable companies; and the new requirements for the most part simply state what most consumers assume. Most of us purchasing products on Amazon would expect that the label is accurate regarding the list of ingredients and their potency. This will now need to be verified, as will substantiation that the ingredients are safe and lawful for the intended use. Though documents and labels can be falsified to appear to accurately depict the contents and manufacturing processes of the product being sold, it will now take more effort to deceive the consumer – and that is a good thing.
Amazon does need to increase their support resources for sellers who want to comply so documentation can be provided accurately and as efficiently as possible.
At a regulatory summit in the latter part of last year Steven Tave, director of the FDA’s Office of Strategic Planning and Operational Policy, stated that there was a “regulatory gap” in the natural products industry — the gap between what the law requires, or compliance, and what can realistically be achieved through enforcement. Please comment on this.
There are two issues that contribute to this large regulatory gap, First, anyone who has ever attempted to read through the FDA’s published regulations on dietary supplement labeling plus all the subsequent amendments recognizes that the requirements are extensive. Added on to these requirements are FDA’s guidance documents, that are not requirements, but could be interpreted as strong suggestions. Monitoring compliance to every detail is impossible, and as a result, FDA has concentrated on disease claim enforcement. But if a label is scrutinized because of potential disease claims, other areas of non-compliance are often noted as well.
Secondly, social media has opened up a vast domain where a product can be marketed and sold as well as monitored by FDA and FTC. Links from social media to a product website can be deemed a point-of-sale, so any claims made, including testimonials, must fall within the regulatory boundaries set by FDA. This was an arduous regulatory scenario before COVID; and now with FDA preoccupied with COVID-related issues, it has become an even more difficult environment for achieving regulatory consistency. This is a particularly difficult situation for reputable companies trying to follow the government regulations, as they are aware of fly-by-night companies making egregious claims with seeming impunity.
Related to this, some industry leaders have said that they believe that there are “two industries”: (1) the companies that have always worked very hard to comply, and (2) new players, almost exclusively online, who are in it to make a killing. What specific self-regulatory steps can the industry take to reduce the “two industries” problem, if there is a way?
There is probably no way to completely eliminate the “two industries” problem because the less reputable companies are often quite adept at shutting down operations when enforcement begins to close in on them, only to open up within a few months under a new name. However, this shouldn’t dissuade reputable companies from reporting unscrupulous companies. Companies making false claims or giving out other misleading information can be reported to NAD (National Advertising Commission) through their Fast-Track SWIFT (Single Well-defined Issue Fast Track) program. Labeling violations may also be reported to the FDA directly by calling the local FDA office or filing a complaint form online at www.fda.gov.
Although companies are probably losing patience with this situation, but speak to specifically what ways the continuing supply-chain disruptions caused by the COVID-19 pandemic are hurting inventories or endangering quality?
Immediately prior to the global disruptions caused by COVID-19, the US was challenged with the repercussions of tariffs set on products from China and other regions around the world. So, supply issues and increased costs had already begun to be felt when COVID hit. The impact of both events led to tremendous disruptions in the supply of many ingredients, forcing manufacturers to seek alternative suppliers, often sacrificing quality.
Related to this, are persistent out-of-stocks at raw material suppliers forcing finished product manufacturers to re-formulate those OOS ingredients out?
Some companies facing indefinite supply shortages of ingredients have opted to reformulate their products instead of waiting for the desired ingredient to become available. If the ingredient is key to the formulation, a manufacturer is more likely to be willing to wait for the ingredient to become available, or they might seek out an alternative source. Some companies have gotten creative by doing a slight reformulation and then giving the product an adjusted name. Adding a “Plus” or “Enhanced” descriptive to an existing product might help retain loyal customers to the brand, at least temporarily.
Ingredients being substituted with cheap alternatives is a problem of economic adulteration. How widespread is this problem, and briefly, how can manufacturers avoid being duped?
Economic as well as pharmaceutical adulteration are growing issues for dietary supplement manufacturers. Pharmaceutical adulteration is more dangerous to the consumer, especially since quantity and quality of the adulterant can be highly variable.
Economic adulteration involves substituting a low-quality ingredient for a high quality one. Economic adulteration usually involves an attempt to cut costs and enhance profitability, but it can also occur because the desired ingredient is not available. Botanical ingredients are particularly susceptible where there may be several species or subspecies of the same plant with different beneficial attributes. The lower quality ingredients may be more readily available. This presents a particular problem because testing to differentiate species can be costly. Sometimes the distributor is unaware of the substitution. A similar problem can occur when a synthetic ingredient is substituted for a natural one. Synthetic versions of active ingredients are often not backed by the same level of research.
The best way to prevent adulteration is to only work with reputable suppliers and insist on the necessary paperwork. Some ingredients are backed by authentication testing as part of the standard documentation. For example, curcumin is a highly adulterated ingredient with both low-quality species and with synthetic forms. Carbon-14 testing is one way to ensure that the curcumin being purchased is natural curcumin from Curcuma longa.
Adulterated and illicit products were the subject of a paper published March 23rd in the journal, Clinical Toxicology, whose authors found nine potentially dangerous stimulants in 17 supplement products sold in the U.S. Does this indicate a much larger problem than we realized, or something else; please explain.
Certain product categories are much more prone to pharmaceutical adulteration; and as long as these types of products are marketed and sold, the problem will probably continue. Products that result in temporary rapid weight loss, sexual enhancement products and muscle-building sports products are all very vulnerable to adulteration because the chemical adulterants are cheap and readily available, though often unsafe.
Quality is also about the science. In what tangible ways is having relevant science behind ingredients so important? And how can this science be better communicated to the public at large?
Groundwork that is based upon science along with published research on ingredients and the formulations created from them provides an extra level of knowledge into anticipated functioning in the body and indicates that the suppliers of those ingredients are committed to the consumer and not just to their bottom line. Research that encompasses a broad range of study types including clinical randomized controlled trials, in vitro mode-of-action studies and animal studies can not only demonstrate that a product works, but also provide answers regarding how it works, can substantiate safety and can sometimes reveal unanticipated benefits.
Unfortunately, the bigger influence on the successful sale of an ingredient or product is probably clever and effective marketing and not the science. But the clever marketing will only go so far if the product doesn’t work. Successful long-term sales depend upon consumer perception. If the product works, the consumer will most likely buy it again. Ideally the supporting science is conveyed in a way that is compelling and understandable.
Along these lines, a percentage of consumers and media outlets continue to believe that the supplement is an unregulated Wild West filled with crazy companies and dangerous products. What can be done to change this paradigm?
The best way to change this mindset is to do whatever is possible to rid the industry of the few companies that sell outlandish products and replace them with companies that vie for top billing in the consumers perception of safety, efficacy and quality.
Industry coordination with the FDA and FTC would accurately give the consumer products they can trust. Big Pharma has too much influence over the regulatory bodies. For now, regulation is mostly dependent upon self-regulation within the DS industry. FDA and FTC should do their job in consistently and accurately regulating an industry that, in many ways, provides a better way to sustain long-term health - and that is the ultimate goal.
Talk about clean labels, and what do they mean for your company? Expand.
Demand for transparency and truth by consumers has challenged the Dietary Supplement and Functional Foods industries all the way from raw ingredient supplier to finished product marketer. Consumers who desire products with clean labels that are truthful and with an ingredient list that is easily understood are often willing to pay a premium for high-quality products.
They want to be assured that if a product states that it contains “natural” ingredients, then it does contain them and not a synthetic substitute cheaply made in a lab. The end-consumer deserves to know what is in their products, and manufacturers and distributors need to know they can trust their ingredient suppliers to provide raw ingredients that are what they say they are.
Stratum Nutrition is committed to seeking out ingredients that meet the needs of the end-consumer who wants simple, clean foods and supplements that are both safe and efficacious. The ingredients supplied by Stratum can be easily incorporated by reputable manufacturers into environmentally friendly, clean-labeled products for both human and veterinary use.
As consumers become more label-savvy, manufacturers who are proactive in being transparent, formulating with clean ingredients and building trust will benefit their bottom line.
For suppliers and manufacturers, briefly what is the most important quality differentiator that sets your ingredients apart?
The most important quality differentiator setting our ingredients apart is our science. Our carefully designed research is a true testament to the strength behind the science of NEM® and why it has been the leader in the eggshell membrane category for the past 15 years.
NEM is one of the few joint health ingredients, and the only eggshell membrane ingredient, that is supported by a full portfolio of 16 research studies, including 4 randomized placebo-controlled trials (2 of which are healthy person trials); 4 open label clinical trials (3 of which are independent trials); veterinary trials, including one canine RCT; and a wide range of supporting in vitro and in vivo mechanism of action studies. In addition to the subjective endpoints like joint pain and stiffness, recent healthy population clinical trials have included objective endpoints via CTX-II, a cartilage degradation biomarker, giving the results additional credibility and substantiation.
An emphasis on science applies to the other ingredients that Stratum supplies as well. Stratum markets a wide variety of research-supported ingredients that are backed by extensive research portfolios, including BLIS K12™, BLIS M18™ and LBiome™.
You can read the full article and see what others on the panel had to say at: Compliance and Improving Quality—Assessing an Industry’s Vital Signs (niemagazine.com).