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Coming soon to a supplement label near you

Coming soon to a supplement label near you

Food and dietary supplement labels will be changing right in front of consumers’ eyes. Some already are. And that’s a good thing—but brands must be ready.

In 2016, FDA announced its Final Rule requiring both the Nutrition Facts and Supplement Facts boxes on product labels get updated to reflect new scientific information and to help consumers make more informed choices. It subsequently extended the compliance deadline, mandating that most manufacturers complete these changes by January 2020, although small producers get an extra year to comply. The labels on store shelves already are changing as manufacturers begin phasing in these new requirements.

Some of these revisions were welcomed by the industry. One of the primary changes is new percent Daily Value (%DV) for some essential nutrients to replace outdated science that was 20 to 30 years old. These updated values reflect what we know now about how much average consumers need of these nutrients and what their daily diets are likely to provide. It turns out, we need more of some nutrients than previously thought and less of others.

In some cases, the new label requirements have led brands to reformulate rather than relabel. Some brands want to be able to declare 100 percent of the DV or continue to market their products as “good” or “excellent” sources of a particular nutrient (terms that are tied to the Daily Values). So rather than change labels, manufacturers chose to change ingredient levels. New formulations mean new safety analyses and new stability tests to keep the claimed percentages constant.

FDA also is mandating additional label information and changing the required vitamins and minerals that must be disclosed on the label. For example, the amount and percent Daily Value of sugars added to a product must be disclosed. Vitamins A and C will no longer be mandatory on the label, but vitamin D and potassium will be declared along with calcium and iron. Still other changes include changing units of measurement for vitamins A, D and E from International Units, or IU, to more common measures of milligrams and micrograms. And folic acid—an important nutrient before and during pregnancy—will be listed as folate and be measured in micrograms of dietary folate equivalents (DFE).

Read The Full Article HERE

Joint Health Supplements: Steadily, flexibly forward

Joint Health Steadily flexibly forward

As the global joint health market grows a steady 7 percent over the next three years, the category’s staple dietary ingredients and products are giving way to a fresh wave of botanicals and specialty compounds, bringing researched joint and inflammation management to a wider, active audience than those with aging bodies.

Beyond Relief. “Consumers want products that improve their health, not products that mask their symptoms,” explained Tim Hammond, vice president of sales and marketing, Bergstrom Nutrition. In fact, as joint health and function is something consumers want to preserve over a lifetime, they are looking for customized joint health solutions that are safe for long-term use. For many, this means a small, daily supplement dose—but for others, including the younger generations, alternative delivery formats are the way to joint regimen compliance in busy lives.

Herbs on the Rise. Persistent local inflammation is a recognized key driver of wear and tear joint problems, including osteoarthritis (OA). Inflammation is typically a short-term consequence of activities, but chronic or persistent inflammation can have a lasting damaging effect on joints. Turmeric has reached superfood status and is on the rise in joint health, owing largely to its primary anti-inflammatory constituent curcumin. Additional botanical ingredients offering anti-inflammatory and other joint-related researched benefits include ashwagandha, ginger, Boswellia serrataTerminalia chebulaBacopa monnieri and Kaempferia galangal, which has the cool nickname of “resurrection lily.”

Animals to the Rescue. Despite the growing use of botanicals for inflammation and oxidative stress control, joint health still relies heavily on supplying naturally occurring compounds found in cartilage and synovial fluid, which are commonly derived from animal sources. A popular trademark in this category involves collagen, a critical cartilage component. Research has shown undenatured collagen from chicken and collagen peptide ingredients derived from animal skin and bones deliver key amino acids crucial to improving the structure and function of cartilage and connective tissues, including inflammation management. Also, glucosaminoglycans (GAGs) and other compounds found in healthy cartilage are commonly supplemented through popular ingredients like glucosamine and chondroitin from shellfish, but eggshell membrane has emerged as an alternative animal source that also delivers keratin and collagen, as well as anti-inflammatory compounds.

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FDA commissioner announces plan to modernize regulation of dietary supplements

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The head of FDA on Monday announced a goal to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”

A quarter century after Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has thrived with tens of billions of dollars in annual sales, the majority of U.S. adults taking supplements and an estimated 80,000 products on the U.S. market.

But in a lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency’s policies and capacity to manage emerging risks.

“To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” Gottlieb said. “Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.”

Read The Full Article HERE

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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Takeaways: Sports nutrition for female athletes

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.

Read The Full Article HERE

Essential fatty acids health benefits

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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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Are There Too Many Supplement Brands?

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If you spend any amount of time around industry events or targeted social media pages, you have likely heard…

“There are way too many brands today!”

…from brand owners, brand employees, retail shop owners, and every other stakeholder in the industry.

So, is there actually too many nutritional supplement brands?

I mean it certainly feels like it. Regardless if you are a stakeholder that looks at the industry from a science or marketing side, they both have been infiltrated by this proliferation in brand creation in the last 5 years. This has been caused by low barriers of entry in both national distribution (direct to consumer and Amazon) and national marketing (social media). This causes a slew of competition that creates noise and spikes different market economics.

Feel is one thing but what about the facts. Lets look at the economics definition of market saturation.

Market saturation is when sales of a product (or service) has reached the point that customer needs have been met. The term implies a situation in which sales growth is unlikely.

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Harnessing the Power of Matcha (Podcast)

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Takeaways

  • Matcha is an 800 year old ingredient
  • It’s uniqueness comes from its color, flavor, and texture.
  • Full of amazing health benefits

What are the health benefits of Matcha?

  • Amazing Antioxidant
  • High in Alkaline
  • Aids in digestion
  • Superfood (By Most Measurements)
  • 30% Protein & Fiber
  • Loaded with Vitamins & Minerals

Where is Matcha Tea traditionally grown?

High quality Matcha is sourced from Japan in the town of Nishio.

What Factors affect quality?

The factors that affect quality are the growing regions, soil conditions, weather conditions, and also the experience of the farmers.

State of the Nutraceuticals Industry for 2019

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In October 2018, Nutraceuticals World conducted a survey of readers to gain insight into their perceptions and attitudes toward the state of the industry. We received responses from 142 qualified industry members working at companies that manufacture, market, or distribute finished nutraceutical products—such as dietary supplements, functional foods, or nutritional beverages—or raw nutritional ingredients for inclusion in finished consumer products. The charts and graphics that follow illustrate results.

Highlights
Overall, confidence in the future of the nutraceuticals market was high; 85% of respondents said they are “very” confident in the future, and another 14% said they are “somewhat” confident. Compared to last year, 60% of respondents are more confident this year and only 12% are less confident.

Among the biggest concerns were regulations (65%), negative or misleading news about the industry (55%), and quality issues (43%). Also of note, 69% of respondents indicated their company is interested in implementing or planning to incorporate clinical research into their business plans. Another 52% cited “increased transparency,” and 51% said delivery/dosage technologies.

Read The Full Article HERE

Farm bill is now law, will ‘unleash the full potential of hemp’

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Ask around, and there’s a palpable buzz in the air.

Passage of the 2018 Farm Bill was a rare bipartisan affair—last week it passed the U.S. Senate, 87-13, and it passed the U.S. House, 369-47. President Trump signed the bill into law Thursday, Dec. 20.

Already, there’s an estimated 750 brands in the hemp-derived CBD business, according to a market assessment by Colorado-based brand Functional Remedies.

Is there room for 750 more?

In 2016, there was 9,000 acres of industrial hemp grown in the U.S., according to Vote Hemp. In 2017, it nearly tripled, to 25,000 acres. In 2018, it tripled again, to 77,000 acres. How many triples can U.S. hemp farmers hit?

The Farm Bill, which removes hemp from the Controlled Substances Act and thus takes the DEA out of the picture, is a bellwether event—akin to dropping the rope on the Oklahoma border in 1889 for all those sooners to grab their share of free land.

Even without the Farm Bill, CBD in 2018 grew by more than 80 percent, reaching an estimated $590 million, according to the Brightfield Group.

Read The Full Article HERE

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