Regulatory Overview

Dynamics of current regulations

A message from the founder of BioSmart Research, Inc. – Renee Searle

The marketing strategies for CBD and cannabis products have been significantly curtailed by regulatory red-tape and each state’s attempts to capitalize on the tax base that could be generated from the sale of the products.  These issues coupled with a general lack of understanding as to what is required in order to make an effective supplement forces companies to develop marketing strategies within the confines of all the regulatory issues.  

Here are the parameters that we are working under and the dilemmas that we face.

When some of the key ingredients in a formula are omitted from the formula because of regulatory issues, it can potentially marginalize the effectiveness of the formula.

The addition of a small amount of THC under the .3% limit would also increase the effectiveness, but most people don’t want any THC in a nutraceutical product.

We offer both types of formulas depending on your preference.  You have choices.

That is what BioSmart Research is all about.  Getting therapeutic results at an affordable price.

Additional articles

Though many patients seek access to medicinal marijuana, some doctors are reluctant to recommend it due to a dearth of hard clinical data regarding its efficacy in treating certain conditions [9]. Marijuana’s schedule 1 status makes it difficult to conduct research because any cultivation, clinical testing, or research on it must attain the extremely rare approval of the federal government [17], and only one organization, the National Center for Natural Products Research at the University of Mississippi, is authorized by the federal government to manufacture marijuana [18]. This creates a vicious circle: marijuana is schedule 1 and has no currently accepted medical use in treatment because there is no data on its safety and efficacy; there is no data because marijuana is schedule 1 and clinical testing is restricted or prohibited [19].

Aside from the lack of data on efficacy, some doctors are reluctant to recommend a drug whose form, contents, dosage, and type cannot be specified, as they would be in a typical drug prescription [14]. The amount of marijuana the patient can obtain is limited by state law [20]. The type of marijuana and mode of delivery is determined by the recommendations of dispensary employees [9]. Furthermore, because of its dual legal status, the product and its growing and cultivation are largely unregulated and unstandardized. This can lead to safety concerns; there have been incidents of pesticides, molds, and other contaminants, the consumption of which could lead to serious health problems, being found on plants [21].

In states where medicinal marijuana is legal, but a majority of physicians are reluctant to write recommendations, an influx of “pot docs” is often seen, reflecting a commercialization of medical marijuana recommendations [3]. These are physicians who primarily treat a variety of ailments for which marijuana is recommended, and they often advertise their businesses as being centered on medicinal marijuana [3]. This is a concern to some in the states whose medicalization movements were predicated on the belief that medicinal marijuana would only be available to a limited number of people with debilitating conditions and would not facilitate recreational use of the drug [8, 12]. Proponents of medicalization argue that doctors often prescribe drugs for off-label purposes, thus strict limits on ailments warranting recommendations would unduly restrict patients’ access to the medicine [8].

But many states expand their covered ailments beyond such extreme conditions [8]. Because, for example, California’s law about the conditions for which marijuana use is allowed includes a catchall “or any other illness for which marijuana provides relief” provision [12], pot docs are able to write prescriptions for problems such as anxiety, insomnia, and chronic pain [3, 8]. Some physicians feel that these pot docs cheapen the profession by acting as quasi-medical drug dealers who make money by providing their patient with an easy, accessible high, rather than treating a serious ailment [3].

Some states are trying to avoid this by requiring that recommending physicians have an existing bona fide clinical relationship with the patient who is seeking the recommendation [9, 14]. Of course, this requirement, while protecting the legitimacy of the recommendation, may create tension within the patient-doctor relationship when patient desires medicinal marijuana but the physician will not recommend it, either for reasons having to do with its therapeutic potential, lack of control over the dosage patients receive, or overall objections to its use [6].

One last objection that physicians in some states have with medicinal marijuana is the lack of regulation regarding clinical training on the medical and legal aspects of the new laws [14]. Massachusetts was the first state to require that physicians take a two-hour course before they could recommend medicinal marijuana to their patients [22]. Doctors generally prescribe only drugs that have been rigorously tested, their clinical results reported in published articles, and information about indications for their use, the mechanisms by which they achieve results, and their expected side effects available in package inserts or the Physicians’ Desk Reference. None of these resources for information about the efficacy, dosing, or regulations that come from FDA-approved drugs are available for medical marijuana [22].

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