Regulatory and taste issues slow CBD formulation efforts | 2021-03-16

Will Kreznick

KANSAS CITY — Knowing regulatory requirements and getting rid of unwanted tastes will prove crucial when working with cannabidiol (CBD), a hemp extract. COVID-19 had a negative effect on sales last year, but the CBD category still shows promise. The total US hemp-based market stood at $912 million in 2020, […]

KANSAS CITY — Knowing regulatory requirements and getting rid of unwanted tastes will prove crucial when working with cannabidiol (CBD), a hemp extract.

COVID-19 had a negative effect on sales last year, but the CBD category still shows promise. The total US hemp-based market stood at $912 million in 2020, up 0.4% from 2019, according to New Hope Network/Nutrition Business Journal, which expects sales growth to pick up in the middle of 2022 and forecasts the market to reach nearly $1.4 billion in 2023. The food and beverage category made up 0.5% of the US hemp/CBD market in 2020.

The Food and Drug Administration has ruled CBD may not be used legally in foods, beverages and dietary supplements since it is approved for use in a drug called Epidiolex. Hopes are the FDA eventually will define legal ways to use CBD in foods, beverages and dietary supplements.

“The Biden administration wants this on a national level,” said Suzy Badaracco, president of Culinary Tides, Fort Lauderdale, Fla. “The FDA wants it at a national level to regulate it. The DEA, Drug Enforcement Agency, also wants this at a federal level.”

However, she expects the FDA to focus more on COVID-19 this year with federal CBD legislation to follow in 2022.

Nixon Peabody LLP gives best practices to its clients who are working with hemp. CBD is a “grey area,” said Hannah Bornstein, partner and deputy leader of government regulations and white collar defense practice for Nixon Peabody and based in Boston. The FDA is concerned with companies making therapeutic claims, she said, giving examples of products being promoted for treating pain for arthritis, alleviating cancer pain, improving functioning for consumers with Alzheimer’s, and treating or preventing COVID-19.

“Those are the types of explicit marketing claims that companies have made that are resulting in warning letters,” Ms. Bornstein said. “Certainly, that puts an initial red flag. It’s pretty easy for the agency to spot.”

Both hemp and marijuana are Cannabis sativa L. Any cannabis plant containing more than 0.3% tetrahydrocannabinol (THC) is considered marijuana. Hemp contains 0.3% THC or less. The Agriculture Improvement Act of 2018, also known as the farm bill, removed hemp from schedule I of the Controlled Substances Act, allowing for commercial hemp farming.

Fewer regulatory problems exist for hemp extracts that do not contain CBD. The FDA ruled in December 2018 it had “no questions” about the Generally Recognized As Safe (GRAS) status of food ingredients derived from hemp seed.

“Manufacturers might not be aware that because hemp protein is derived from the seeds of the plant, it is not subject to the same regulatory hurdles as other hemp-related ingredients,” said Brian Zapp, creative director for Applied Food Sciences (AFS), Austin, Texas. “Hemp protein is considered safe in all 50 states for the intended use to replace other dietary proteins similar to other common plant-based ingredients like rice or pea protein.”

AFS offers a V-70 hemp heart protein ingredient that is 70% protein, Mr. Zapp said. Hemp seeds contain amino acids, including arginine, along with fiber and polyunsaturated fats, he said.

Hemp seeds typically have a bitter, pungent taste, Mr. Zapp said, but AFS partnered with Victory Hemp Foods, Carrollton, Ky., which has a proprietary dehulling process, to tackle the taste issue.

“By removing the outer shells of hemp seeds, we can work with just the white hemp hearts, presenting much cleaner ingredients with a neutral taste profile and pleasant white appearance,” he said, adding the protein in the hemp heart offers savory traits.

“But perhaps most impressive is in plant-based meats, hemp protein has gelling and emulsification properties that make for juicier, more authentic meat textures,” Mr. Zapp said.

Hemp heart protein adds a creamy mouthfeel to shakes, smoothies and cold-brew coffee, he said. Hemp heart oil is a light, straw-colored oil with a mild nutty flavor similar to the flavor of pine nuts, he said.

“The functional omega-3 fatty acids, with an appealing taste and color, make it ideal for culinary applications like salad dressings, spreads, dips and baked goods,” Mr. Zapp said.

Many food and beverage products contain CBD despite the lack of FDA approval, and strategies have been crafted to help solve taste issues in CBD-containing products, too.

Hemp-based CBD ingredients are best used in bakery products with stronger flavors such as chocolate, coffee, caramel or berry, said Elizabeth Arndt, PhD, director of R&D for Viobin, a business of Denver-based PHM Brands. Masking flavor technology also helps to counteract the flavor notes inherent to hemp-based CBD ingredients. Dr. Arndt suggested starting use rates for product development at 2 to 10 mg of CBD per serving based on the RACC (reference amount customarily consumed per eating occasion).

Full spectrum hemp extract contains at least 75% CBD along with other cannabinoids and components that naturally occur in hemp.

“Full-spectrum hemp extract has an herbaceous, earthy flavor with bitter afternotes that is best suited for use in bakery mixes and foods with stronger flavors such as chocolate fudge brownie mix or multigrain pancake mix,” Dr. Arndt said.

CBD isolate, a free-flowing white crystalline powder, contains at least 98% CBD.

“It has an overall bland flavor with a slightly bitter aftertaste making it amenable for use in a broad range of bakery products, including those with more delicate flavors and lighter colors, such as lemon poppyseed muffins,” Dr. Arndt said.

Hemp Synergistics, Leetsdale, Pa., offers a baking mix that is 20% CBD. 5 Generation Bakers, McKees Rocks, Pa., has worked with Hemp Synergistics to create baked foods. Each individually wrapped brownie and cookie from 5 Generation Bakers contains 22 mg of CBD. The CBD levels meet regulations in the state of New York stating food and beverage products may not contain more than 25 mg of cannabinoids per product, said Daniel Kohler, chief executive officer of Hemp Synergistics.

“The hemp bake mix is designed to be tasteless and not affect the recipe in amounts well beyond standard dosing levels,” he said. “While the product will remain tasteless far beyond 100 mg per serving, we recommend formulating to a maximum dose of 25 mg.”

Problems in meeting label claims regarding CBD levels may crop up. An oil-based ingredient like CBD does not play well with water, making it difficult to infuse it into a food or beverage because it does not always disperse evenly, said Donna Wamsley, director of research for Sorse Technology, Seattle.

“Creating a shelf-stable and homogenous water-soluble emulsion makes CBD easier to work with for the product developer and makes ingesting the finished product a more enjoyable experience for the consumer,” she said. “The most important goals when converting CBD into an emulsion is homogeneity, stability and accurate dosing.”

Sorse Technology works to make certain the product has the same dosage every time and is shelf stable for at least 12 months, she said.

“Homogeneity ensures that the first sip contains the same amount of CBD as the last,” Ms. Wamsley said. 

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