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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 The draft guidance on NDI notifications, issued in August 2016, clarifies this thinking regarding what results in chemical alteration.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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Takeaways: Sports nutrition for female athletes

The world is half female. At least half of the sporting world is female; however, most products are formulated for men or based on research conducted mostly on men.

Women are not small men. They are different anatomically, physiologically, biologically and biochemically. The biggest difference, and one of the primary reasons given for lack of female-specific sports nutrition research, is the menstrual cycle. During certain phases of their cycle, women can experience hormone fluctuations that affect muscles, energy and bone health.

There is tremendous opportunity for companies to capture part of this growing category, but it will require an approach that considers and respects the uniqueness of active females.

Research, Research, Research. It is up to brands and manufacturers to request, fund and support increased research on female athletes. Accept and account for challenges from menstrual cycle influences. “The inane idea that women are more difficult or more expensive to study is pure laziness, in my opinion,” said Susan Kleiner, Ph.D., R.D., owner of High Performance Nutrition LLC and nutritionist for many elite female sports teams.

For instance, researchers like Bill Campbell, Ph.D., associate professor of exercise science at the University of South Florida, purposefully does not plan trials around menstrual cycles. “The reason I do not consider the menstrual cycle in my studies is that I like to be able to extrapolate my results by saying that the outcomes were irrespective of the female’s menstrual cycle,” he explained.

More companies, such as sports nutrition brand Dymatize and ingredient supplier Bergstrom Nurition, are funding studies on females. Abbie Smith-Ryan, Ph.D., associate professor of exercise physiology and director of the Applied Physiology Lab at University of North Carolina, Chapel Hill, who also conducts studies on females, reported NIH now requires researchers to justify why they are or are not including women in their research proposals.

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Essential fatty acids health benefits

Fatty acids belong to a category of biological molecules called lipids (or fats), which are generally water-insoluble but highly soluble in organic solvents. Chemically, a fatty acid is a non-polar long aliphatic hydrocarbon molecule chain that has an acidic carboxylic acid group (COOH) at one end of its molecule, and a methyl group (CH3) at the other end, which is designated omega or ω. The COOH being at one end is what makes these molecules acids. Most naturally occurring fatty acids have an unbranched chain of an even number of carbon atoms (from four to 28). They have the general structure of CH3(CH2)nCOOH.

Fatty acids are derived from both animal and vegetable fats and oils. They are a necessary part of nutrition, and have uses outside the body (such as lubricants, cooking, soaps, detergents and cosmetics).

Fatty acids can be categorized in various ways, although they are primarily categorized through the degree of saturation or variation of chain length.

A saturated fatty acid has no double bonds. Saturated fatty acids are solid at room temperature, have high melting points and are common in animal and plant fats.

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The plant-based protein market — deep dive

In the past decade, products made with plant proteins have evolved to include a wide variety of flavors, textures and formats for every eating occasion. A broader range of consumers now seeks plant-based protein goods, particularly consumers under age 40 who eat meat but are incorporating other options. Dairy alternative, sports nutrition and snacks are some of the top categories for plant-protein products, drawing from sources such as soy, pea, lentil and ancient grains.

Takeaways for your business

• Taste is the top reason for eating plant proteins, far outranking concerns about environment or diet.
• 46% of consumers surveyed believe plant-based proteins are healthier than animal-based counterparts.
• Convenience foods, prepared breakfast items, frozen prepared foods and entrées show great potential.

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New research on curcumin’s health benefits

The big question about turmeric and curcumin asks how long its explosive growth will last. Will this superstar spice ingredient sustain its popularity and reach omega-3 status or fade into the background as a once-hot natural product trend? Thanks to the wide body of data generated in recent years, curcumin’s benefits categories have broadened substantially.

Sports nutrition is an up-and-coming benefit sector for curcumin, especially in light of its potential to reduce inflammation and soreness caused by strenuous exercise. The antioxidant benefits of curcumin and its ability to modulate inflammatory pathways underscores its potential as an adjunct to recovery.1

In a recent randomized, double-blind, placebo-controlled study, curcumin was shown to be an effective supplement for recovery after strenuous exercise.2 An additional study also reported a reduction in 24-hour pain scores as well as increased muscle performance after a muscle-damaging exercise.3

Curcumin is also finding potential in heart health, where the effects of its anti-inflammatory properties are being researched. Recently, a highly bioavailable form of curcumin was studied in a healthy population to examine its role in endothelial function, which plays a critical role in cardiovascular health.4 Curcumin’s direct impact on healthy circulation was measured using flow mediated dilation (FMD).

The randomized, double-blind, placebo-controlled study showed supplementing with 200 mg of curcumin had a clinically meaningful impact on potentially reducing cardiovascular disease by up to 50 percent in healthy individuals.

As the buzz around turmeric and its active component, curcumin, continues to spread, market opportunities for these popular ingredients are expanding.

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A newcomer’s guide to the supplement industry

According to the Council for Responsible Nutrition’s (CRN) Economic Impact Report, more than 750,000 Americans are employed by the dietary supplement industry in the United States. The industry is an eclectic bunch, spanning all age groups and backgrounds, specializations and skill sets, but one common trait exists: a desire to make an appreciable difference in people’s lives.

The hard work is paying off. Data from Nutrition Business Journal (NBJ) show the industry grew by 77 percent between 2005 and 2015—and it’s still growing! Thanks to industry’s commitment to product integrity, sound science and consumer safety, dietary supplements have become an integral part of health and wellness regimens across the nation, and the demand for more product and next-level innovation means the industry’s workforce is expanding.

For those who may have just entered the space, whether new to the workforce or a seasoned executive joining from a different industry, there’s a lot to learn about dietary supplements.To all the fresh faces feeling overwhelmed, a few things to know:

Dietary supplements are regulated. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA)—a law Steve Mister, president and CEO, CRN, once called “industry’s permission slip to exist.” DSHEA reaffirmed that supplements are regulated as a category of food—not drugs—and provided FDA with regulatory authority over the industry. With DSHEA serving as the law of the land, extensive regulations cover all facets of dietary supplement manufacturing, labeling and marketing.

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