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Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts

Massachusetts Rep. Kay Kahn, a Democrat from the Boston suburb of Newton, refiled a bill in January that would restrict sales of certain weight loss and muscle building dietary supplements to minors, requiring retailers to post dire warnings of potential injuries and even death, as well as placing these supplements behind the counter.

Introduced in the Democrat-controlled House last week, the new bill (H.D. 2883) is unchanged from bill H.1195, which Kahn introduced in the 2017-2018 legislative session.

It would require retailers to limit access of weight loss and muscle building supplements to any consumer under the age of 18, essentially putting the products under lock and key and permitting access by store manager only.

The bill also proposes a requirement that retailers of such supplements post a warning on the counter “that certain over-the-counter diet pills, or dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death.”

The state’s Department of Public health would determine the exact warning language and partner with FDA and key stakeholders, including the eating disorder community, to determine which weight and muscle products would be restricted for sale.

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Joint Health Supplements: 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

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

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.

Read The Full Article HERE

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.

Read The Full Article HERE

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.

Read The Full Article HERE

CBD: A legal and regulatory update

Over the past few years, cannabidiol (CBD) has become a household term. Moms, dads, brothers, sisters and even grandparents know what CBD is. At the least, they have probably heard of it. Cannabis sativa L. is a plant that includes both marijuana and hemp. CBD is a naturally occurring cannabinoid found in the cannabis plant. Hemp has a much lower concentration of delta-9 tetrahydrocannabinol (THC), the psychoactive chemical found in high amounts in marijuana.

On Dec. 20, 2018, President Donald Trump signed the Agriculture Improvement Act of 2018 (2018 Farm Bill), changing the landscape for companies involved in the hemp industry. Prior to the 2018 Farm Bill, the 2014 Farm Bill governed the growing and cultivation of hemp in the United States. The 2014 Farm Bill allowed for the growing and cultivation of “industrial hemp,” which was defined as “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” The 2018 Farm Bill significantly broadens the definition of “hemp” to mean “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Notably, the 2018 Farm Bill simply states “hemp” in its definition, rather than “industrial hemp,” and it includes the specific parts of the plant and its chemical constituents.

Read The Full Article HERE

Are There Too Many Supplement Brands?

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.

Read The Full Article HERE

Getting Ahead of the Curve: Consumers Seeking Specialty Nutritionals

As the variety of supplements, functional foods, ingredients, and bioactives continue to diversify to meet an ever more sophisticated list of health/wellness issues, it’s not surprising that
consumers are beginning to worry if they’re getting enough of the specialty nutritional ingredients they perceive important for their needs.

While 20% of adults don’t think they get enough basic vitamins/minerals, even more consumers—30% of gen Xers, 27% of millennials, and 24% of adults overall—don’t believe they get enough specialty nutrients, according to FMI’s 2018 U.S. Grocery Shopper Trends. Women (26% vs. 20% of men) are more likely to be concerned about their intake of specialty nutrients; one in five boomers and 16% of matures.

After vitamins/minerals, specialty supplements are the most used category of dietary supplements, taken by 51%; followed by herbals/botanicals (41%), sports nutrition (32%), and weight management supplements (20%), according to the Council for Responsible Nutrition’s2018 Consumer Survey on Dietary Supplements.

Read The Full Article HERE

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