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CBD concentration matters

CBD concentration matters

t’s true cannabidiol (CBD) is a drug. GW Pharmaceuticals went to great effort and expense to determine the clinical benefits of CBD. The specific, single-entity chemical is considered a drug because FDA approved it as one, and that is how the U.S. regulatory system operates. The regulatory system also renders items as drugs based exclusively on what is said about them. Cognitive dissonance occurs with different interpretations of the law, and this dissonance, while remaining unresolved, affords opportunity.

Harvesting CBD from hemp raw material (the botanical that was so much the focus of the passage of the Agriculture Improvement Act of 2018, otherwise known as the Farm Bill) is acceptable from a statutory perspective. Hemp products have recently passed through FDA review with a few specific new ingredients (not all) being considered GRAS (generally recognized as safe) for use in foods. The presence of CBD in hemp products additionally renders it consumed in conventional foods. The lack of objection to these hemp product GRAS notifications affirms FDA’s current determination regarding the safety of CBD and tetrahydrocannabinol (THC).

The question of whether this lack of objection extends to use in dietary supplements is a separate, open issue. Proper notification of CBD products as new dietary ingredients (NDIs) for use in dietary supplements is mandatory unless the article of food (hemp) has not been “chemically altered.” The current thinking from FDA is that just about anything is considered chemical alteration. The draft guidance on NDI notifications, issued in August 2016, clarifies this thinking regarding what results in chemical alteration.

Peak cognitive dissonance occurred when FDA Commissioner Scott Gottlieb, M.D., said in a Dec. 20, 2018 statement, “. . . it’s unlawful under the Federal Food, Drug and Cosmetic Act (FD&C) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” While FDA did not recently object to three GRAS notices for hemp products that contain trace amounts of both CBD and THC, it simultaneously stated its conclusions do not affect its position in an FDA Q&A on marijuana: It is a prohibited act under federal law “to introduce into interstate commerce a food to which CBD or THC has been added.” This is reminiscent of the similar agency view on the presence of lovastatin in products marketed as red yeast rice supplements and the related regulatory challenges it posed from years past.

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NutraCap Labs

About NutraCap Labs

OUR MISSION:
NutraCap Labs’ mission is to provide our customers with the highest quality products and an industry-best customer service experience. Based in Atlanta, GA, NutraCap Labs is a manufacturer of Nutraceuticals/Dietary Supplements and we are experiencing explosive growth. As a GMP compliant and an FDA registered company, we specialize in encapsulation manufacturing, sports nutrition and raw health powders, product formulation, brand design and distribution. Private Label manufacturing is the fastest growing sector of our business and our biggest strength due to the relationships we have built with our customers.

OUR GOAL:
Our goal at NutraCap Labs is to partner with our customers to create the best products possible through custom formulation, in-house label design and other services that we offer. Additionally, through our sister company, Active Sports Distribution, we market and sell some of the health and fitness industry’s most popular supplements to retail stores worldwide. With the Nutraceutical industry approaching $85 billion annually, we are excited to become a leader in this arena. Our experienced management team is committed to bringing ethics and professionalism to the forefront of the industry.

At Nutracap Labs we aim to lower what has always been a high barrier to entry into the dietary supplement industry. Our minimums start at 144 units per product and allows lower risk for two categories of customer. 1. Those who may be working with limited capital and cannot tolerate much risk. 2. Those who have the capital but are interested in testing the market before they scale their business
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