WCQI ICEBREAKER: Solving The Quality Gaps - Edible Marijuana Products in Colorado

In advance of the upcoming WCQI, I wanted to submit a post that would be an effective conversational icebreaker.

Over the last few days, a number of news stories have been published describing the problems associated with the recent deregulation and legalization of marijuana, and the unintended side effects.  One concerns the lack of control over edible marijuana products.

The cardiovascular risks of smoking any substance, whether tobacco, marijuana, or herbal cigarettes, include increased viscosity of blood and arterial stenosis, which are significant contributors to heart and stroke related maladies. As an alternative, people consume their narcotic in the form of food and drink.  This makes marijuana a food additive.

Federal governments already have regulations for food additives.  As an example, the USA has the following regulation available at this link.

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)   PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart A--General Provisions

Sec. 172.5 General provisions for direct food additives. (a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions. (1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food. (2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient. (b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act. (c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans.

The unanticipated effect of introducing drinks, cookies, candies, and other treats with the marijuana food additive is the overconsumption of the THC narcotic.  While there are limits of 10 mg of THC per serving, our North American culture does not practice effective portion control.  As a result, there are instances of overdoses leading to death or destructive behavior.

Meanwhile the Associated Press is reporting,
"Colorado authorities are scrambling to do more than rein in edibles.  Lawmakers are considering legislation that would require edibles - the cookies and candies themselves, not just the wrappers - to be marked and colored to indicate they contain marijuana.  Another bill would reduce possession limits on concentrated marijuana"

Now that we recognize a Quality Gap, what can we as Quality Practitioners do to bring this situation under control and stability?

• As a Food Additive, the cultivation, processing, and integration of marijuana substances into food must be planned and governed according to the FDA Quality Systems Regulations, Good Manufacturing Practices, or their international equivalents.

• Given that marijuana is promoted for its contribution to health and wellness, these claims should be validated and verified in a manner consistent with Biomedical practices, and subjected to the necessary clinical tests to support assertions.  These biomedical experiments would also provide the necessary objective evidence to determine recommended and maximum dosage levels for THC consumption within a time period.

• As a potentially toxic food additive with side effects that could cause death or permanent heath impacts, a Hazard Analysis and Critical Control Point (HACCP) program is essential to not only regulate and safeguard the products, but to instill immediate corrective responses where safety constraints are violated.

• A robust product configuration system is needed for edible marijuana products.  Clear identification, traceability, and distribution tracking systems are required to support any product return or recall initiatives that may be required to preserve public safety.  This applies not only to the product itself, but to the packaging and potential redistribution to consumers where such products are not yet legalized.

These are just basic quality approaches that should be applied, regardless of passing opinion on the actual decriminalization of marijuana.  I welcome ideas and interactions from other quality practitioners on the best way to address the quality gaps currently present with the inadequately regulated and controlled edible marijuana items.