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Regulations of dietary supplements
Natural products, like food products and supplements, have been consumed in different forms for centuries of human existence. The most popular forms are crude in preparation and extracted right from the leaves, buds, stem, or roots of these naturally grown products. Sometimes, different civilizations have attempted consumption forms that include mixtures, solvent isolates, herbal derivatives, and granulated pebbles. The cannabis plant has long been used in different forms, even before the advent of regulatory laws that seek to combat unapproved used and prohibited dealings in CBD products.
Dietary supplements are non-prescription substances, either natural or synthetic, that are sold as extra nutrient sources or as an integrative approach to reducing the risk of health complications such as osteoporosis, arthritis, diabetes, and a host of neurodegenerative diseases. The pills, gels, liquids, and powders in the market generally contain essential amino acids, nutrients, fiber, enzymes, plant herbs, and minerals. In different countries of the world, the strict regulations governing the production and sale of prescription drugs are usually not applicable to dietary supplements. In the United States, for instance, dietary supplements are only required to carry a detailed, clear label describing the constituents in each unit of the supplement.
Unlike with prescription medicine and drug products, the U.S. Food and Drug Administration (FDA) neither tests dietary supplements for efficacy and constituent levels nor requests manufacturing companies to publish safety profile data on dietary supplements before marketing them as such. Manufacturers are mandated, however, to follow the good manufacturing practices (GMP) as in drug products to ensure purity, verified identity, and low levels of the harmful contaminants in the supplements. Additionally, manufacturers are further mandated to remind consumers that dietary supplements are not intended to diagnose, treat, cure, or prevent diseases in humans.
Global stance on marketing cannabinoid products as dietary supplements
The CBD industry boom has seen different forms of cannabinoids, especially cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), sold under different labels. Depending on the governing rules in different regions, the production, sale, and use of products derived from cannabis is largely regulated. In the United States, the marketing of conventional food products, dietary supplements, and products containing cannabis or cannabis-derived compounds is regulated by the provisions of the Federal Food, Drug, and Cosmetics Act (FD&C).
Under this Act, both THC and CBD are excluded from the definition of what constitutes a dietary supplement and cannot be sold or marketed as such. By extension, the addition of THC or CBD to any drug product necessitates the removal of the dietary supplement descriptive tag from such a product. Since both cannabinoids are excluded from the dietary supplement schedule, the addition of both compounds and substances containing both compounds to food meant for animal or human consumption is prohibited.
Still, under the Act, the introduction of any food products that contain substances derived from both THC and CBD into interstate commerce is also prohibited. These rules, in large part, are targeted at preventing the unauthorized use of cannabis-derived products in food as dietary supplements. However, the FD&C Act states that ingredients derived from the cannabis plant that do not contain CBD or THC are allowed to be included in food products or sold to consumers as dietary supplements provided that other FD&C requirements as applicable to the product have been fulfilled.
Controversies surrounding cannabinoids as dietary supplements
From a broad perspective, the controversies surrounding the use of cannabinoids in food products as dietary supplements are the same as those affecting the use of cannabis-derived products in general. Following different studies suggesting that cannabis products can be used in the management of some human ailments, it becomes logical for people to explore this product as an alternative to conventional therapy. In addition, many anecdotal reports support the use of cannabis and its derivative in humans. However, the obvious defects in these reports are safety reviews suggesting effective use in humans. Most research trials into cannabis products are conducted in a special population that can sometimes exhibit large variations to the normal population.
As a verdict on these controversies, the FDA has declared that it is not aware of any claim confirming CBD to be generally recognized as safe (GRAS). Despite this declaration, several companies are consistently pushing for their brands to be recognized as such within the CBD consumers’ circle. In 2018, the FDA completed the evaluation of GRAS notices made by a particular manufacturer about three hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. These products were subsequently allowed to be legally marketed in human foods for the claims in the GRAS notices provided that other requirements are complied with.
Future expectations on the status of CBD and THC as dietary supplements
Over time, the CBD industry investors and stakeholders have mounted pressure on the different drug regulatory bodies in their regions to relax the restrictions guiding the production and sale of cannabis-derived products as dietary supplements. The push for this new regulation has taken different forms. In October 2019, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Product Alliance dispatched a joint letter to Congress in a bid to secure a special waiver for CBD under the current regulations governing dietary supplements.
In the same vein, a bill has been filed to amend the FD&C Act. Different sections of the bill are centered on modifying the current definition of “dietary supplement” to allow licensed individuals and companies to introduce CBD into interstate commerce and allow the use of CBD—not other constituents of the cannabis plant—to be used as a food additive in products for humans and animals. If successful, this bill will completely modify the current stance of the FDA on the use of CBD as a dietary supplement.
In all, the lack of a safety data report on the use of CBD and THC as dietary supplements in humans is a great hurdle that could determine the final verdict from different regulatory bodies on the status of cannabis-derived compounds in food products.