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CBD Manufacturer Chaos: Major Quality Control Issues Challenge The Industry: (Newshealthwatch)

With the widespread legalization of marijuana at the state level for both medical and recreational use,  and with federal de-criminalization all but inevitable, mainstream sales of cannabidiol (CBD)-based products have skyrocketed, and they show no signs of slowing down. And while hemp-derived CBD is not considered to be medical marijuana (which comes with its own more complex set of regulations), it is anecdotally believed by many to possess a great number of health-related benefits.

Some of these include symptomatic relief of conditions such as arthritis, anxiety, insomnia, chronic pain, Crohn’s disease, migraines, autoimmune diseases, multiple sclerosis and seizure issues (including childhood  epilepsy), as well as a host of more obscure neurological disorders and musculoskeletal problems.  

CBD’s available forms include capsules, oils, tinctures, creams and edibles containing either isolates,  broad spectrum, or full spectrum ingredients. Each of these forms and ingredients has its own purported signature efficacy in terms of neuroactivity and its own unique bioavailability properties. 

A magnet for opportunists and trouble: CBD manufacturer beware

A young, largely unregulated industry with such a huge profit potential is bound, just by virtue of  human nature and the law of large numbers, to attract some careless players and bad actors, and the  CBD business has its share – from the growers right down to the distributors. While the idea of an open season for ambitious entrepreneurs with its incident fostering of competition truly appeals to the  capitalist in many of us, it has come at a great cost in terms of integrity and quality assurance in  industry practices and products.  

The result is that consumers are often unknowingly purchasing mislabeled, ineffective or even toxic  CBD preparations. Sooner or later, they come to realize this, and it adversely effects brands and  retailers in terms of sales volume and revenues. More insidiously, it is increasingly making the case for  greater regulatory intervention and enforcement by government at federal, state and local levels, as consumers are waking up and complaining.

The end result of increased regulation and scrutiny may  well be higher standards in marketing, production and quality control, but it will serve to put some  industry players out of business. It will also notably raise the cost of being a participant in the industry and doing business.

At the time of this writing, the industry is getting a reputation for questionable  quality controls and flexible ethics. This cannot benefit anyone in the industry, except for the quality conscious consumer, who will look at increased prices as companies in the industry pass on the costs of mandated quality certifications and disclosures, when these come into effect. 

A brief look at some statistics 

And now for the part of the article that everyone either skims or skips over, but that everyone likes to  quote in subsequent conversations: market statistics. Like them or not, statistics offer us some  perspective. Here are a few significant statistics, and you can insert your own exclamation points: 

->> This year, 1 in 4 Americans will use one or more CBD products. As market acceptance grows, this  number can be expected to increase, as will the amount of per capita consumption. 

->> The total American market for CBD products is expected to exceed $22.0 billion by 2028, with  total global consumption anticipated to be two and a half times this much. Americans are anticipated to  continue to be the world’s greatest consumers of CBD products. 

->> At present, in excess of 56% of CBD products sold online are mislabeled. 

->> Less than 40% of CBD products marketed in America contain within 10% of CBD levels specified. Lower levels may cause a formulation to be ineffective, but higher levels may initiate a greater side  effect profile. 

->> More than 8% of CBD products marketed in America contain dangerously toxic levels of lead and  other heavy metals. Heavy metal poisoning (especially from lead and mercury) is a very serious  business and can lead to permanent neurological and brain damage. 

If ever an industry has cried out for regulation and greater controls, the CBD industry is it. These  regulations are coming, and while they may ultimately benefit consumers, they are going to impose a  more expensive and extensive compliance burden on the part of all supply chain participants… growers, manufacturers (direct branded and white labeled), and distributors. This is also expected to thin the  herd of participants who play an active role in the industry, in a kind of regulatory Darwinism. 

The cast of characters and their industry roles: CBD manufacturer quality control

Sellers, for the purposes of our discussion in this article, are any purveyors of products to the end consumers, including entities which include online e-tailers and shops having physical facilities. These sellers are differentiated from suppliers (i.e., distributors or wholesalers) of branded product (which may be directly manufactured or white labeled), direct manufacturers (formularies with substantial physical facilities who create their own products from CBD oils and distillates), and growers.

The face of the industry is, generally speaking, the wholesaler with deeply embedded relationships with growers and direct manufacturers. Simply put, it is generally the wholesaler who puts the label on the product. 

The parties each have specific parts to play, with plenty of responsibilities as well as plenty of profit to go around. Each party has a certain quality assurance role which is, at this point in time, more of a  moral imperative than a legal obligation.

For example, growers should test soil for heavy metal content  and other fundamental contaminants which can be absorbed into plants; they should also avoid the use  of pesticides which have the benefit of potentially increasing viable crop yields, but at the cost of  infusing the hemp with toxins. Manufacturers should be vigilant in terms of avoiding production  practices which may introduce contaminants into their product output, and they should exercise great caution in the precise formulation of products.  

An ever-expanding universe of products, brand names and CBD manufacturers

Consumers are presented with an overwhelming number of different CBD-based products in a large number of brand varieties offered by an astonishingly great number of suppliers, some of whom offer  high-quality, properly labeled products, but many of whom are putting out products that may be taken off of the market if overzealous regulators have their way.

The threat of this occuring is quite real, and too many suppliers and manufacturers, aware of this potentiality, are aggressively flooding the  marketplace with inferior formulations in an attempt to maximize revenues while the industry is still as  open as the Wild West, and before revocations and injunctions can take place. 

As a quick side note, most of the suppliers in the industry have been in business for less than five years, while most of the wholesalers with direct ties to growers and direct manufacturers have been active for less than ten years. The prevalent thinking is that these younger enterprises, run by eager and profit hungry opportunists, tend to be thin on quality control. The darker view is that they might also be somewhat thin on integrity. 

This having been said, there are some smaller, younger, entrepreneurial entrants to the CBD industry and marketplace who are truly dedicated to processing and providing better CBD products, and they are worth watching and patronizing. 

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Consumers are becoming educated 

Importantly, an increasing amount of continuously updated information about CBD in terms of  beneficial uses as well as what to look for in terms of quality and safety is becoming available to  consumers, and these consumers are becoming more particular in terms of what they want and what they will tolerate.

They are beginning to look for certificates of analysis (COAs) and other certifications of best practices and quality in selecting brands and products for purchase. There is  evidence that these increasingly sophisticated consumers are even willing to pay a premium for better  quality products… products that have been manufactured by companies with the certified Good  Manufacturing Processes (cGMP) designation. 

The most transparent CBD companies provide COAs for each product showing that that product  contains no pesticides, mold, or heavy metals, and that it has a federally legal THC content of 0.3% or  less. If a CBD seller does not provide this critical documentation, then consumers should beware. 

Cautious buyers should also scrutinize company websites for unrealistic or unsupported health claims.  Bad reviews are a clear warning sign to stay away. Consumers who are educated about the CBD market may more easily find CBD brands that offer safe and effective products. Many of the warning signs of  bad players are easily discernable.  

Cheaply priced CBD products may be a sign that the producers are using poor quality ingredients or  inferior processes that lead to contamination. Cannabis is a potent phytoremediator, meaning that it readily absorbs contaminants like pesticides and heavy metals from the soil.

Since pesticide use for cannabis production is currently unregulated, some farmers are left to use unregistered chemicals that may be even more dangerous to consumers. In June 2020, InHe Manufacturing, LLC and MHR Brands were forced to issue a recall of 51 CBD products after the Florida Department of Health notified InHe of the presence of high lead levels in its products. Exposure to even low levels of lead can cause neurological impairment.

In children, it may cause learning disabilities and low IQ scores. Some profit hungry CBD producers that use cheap production methods may be putting consumers at risk with dangerous levels of contaminants in their products.  

Fortunately, the more ethically-inclined companies use high-tech production processes that ensure  clean products that are both free of contaminants and compliant with federal limitations on THC content. Unfortunately, there aren’t too many ethical companies for consumers to choose from, or to provide supplies to distributors and white label manufacturers.

Manufacturers who are prepared to make the considerable investment in better practices, quality assurance, and having an overall adherence to a higher standard tend to be mature companies – companies who got into the industry  before CBD became mainstream.

Consumers generally have to be prepared to pay a slight premium  (of course the term “slight” is relative) to buy products which are branded or white-labeled by these  quality-conscious concerns. Complicating matters slightly is the fact that true manufacturers, in the  traditional sense of manufacturing, and growers generally have tightly sewn-up relationships with  wholesalers who truly control the flow of products into the marketplace. Once again, there are some younger, “boutique” companies who are the exception to the “older and bigger is better” perception. 

CBD Manufacturer Chaos: Major Quality Control Issues Challenge The Industry-Original Newshealthwatch Article

CBD manufacturer stand-out

One boutique stand out in an industry filled with a wild mixture of Davids and Goliaths is Partnered Process LLC, a Waukesha, Wisconsin-based enterprise founded in 2018 by lifelong friends and  symbionts Sam Ward and Drew Faude.

The company is fully integrated in terms of its functions, and does a bit of everything from local agriculture and agricultural consulting to wholesaling, white label,  bulk manufacturing, toll processing (utilizing a USDA organic-certified facility) and retail through e commerce and in-store shopping at its local company-owned and operated shop. They use a small batch CBD hemp extraction approach to produce superior quality full spectrum products which are  developing a following among resellers and consumers alike. 

For an up-and-coming enterprise, Partnered Process has very elaborate and substantive quality  assurance and product integrity protocols in place, from environmentally-friendly, fully-organic and  pesticide- and heavy metal-free growing, to third-party laboratory testing, QR coding and tracking.  

While not as prominent or as large in terms of sales volume (Partnered Process reportedly has aggregate sales of less than $10 million) as some of its many micro competitors, its products are  developing a reputation amongst distributors and consumers, both e-tail and in-store, as being markedly superior and safer than those competing within its sphere.

Many of Partnered Process’ competitors  throughout the US do not have the investment in agriculture, distillation technology, quality assurance,  tracking and third-party laboratory certification that make Partnered Process a company to watch, and a probable survivor of any industry purge or regulatory apocalypse.  

CBD Manufacturer Chaos: Major Quality Control Issues Challenge The Industry-Original Newshealthwatch Article

The probable future 

With the perils of regulation and more activist consumerism on the near-term horizon, it is predicted  that a large number of wholesalers and distributors will be forced to exit the market due to any of a  number of factors, including legal and regulatory action, the increased demand and associated expense  for better product quality controls, and consumers becoming more cognizant of the definitive  differences in available CBD products in the marketplace.

Some of the larger, more deeply entrenched  players will vertically integrate or will consolidate in business combinations to generate economies of  scale. Some of the more fortunate smaller entities will be absorbed, by acquisition, into the larger  participants. Some of the more quality-conscious boutiques, like Partnered Process LLC, will survive  as independents and continue to build a loyal consumer and distributor clientele. 

A word of caution to distributors and other sellers who are not sourcing and marketing responsibly: A 

day of reckoning is coming, and it would serve you well to elevate your quality standards sooner rather than later. 

CBD Manufacturer Chaos: Major Quality Control Issues Challenge The Industry: Is an Original NewsHealthwatch Article

Disclaimer

Important Note: The information contained in this article is for general informational purposes only, and should not be construed as health or medical advice, nor is it intended to diagnose, prevent, treat, or cure any disease or health condition. Before embarking on any diet, fitness regimen, or program of nutritional supplementation, it is advisable to consult your healthcare professional in order to determine its safety and probable efficacy in terms of your individual state of health.