Call Us Toll Free (800) 688-5956

Probiotics for improving mental health

The microbes in the gut produce neuroactive compounds that connect to the brain, affecting behavior and mood. There are more than 100 million neurons in the gut—nerve cells, which are normally perceived as brain cells. In fact, the gut is sometimes called the little brain because it is the largest area of nerves outside the brain.

An increasing number of studies link gut health to mood and mental health. In a four-week probiotics study, compared with participants who received a placebo intervention, participants who received probiotics showed a significantly reduced overall cognitive reaction to sad mood, which was largely accounted for by reduced rumination and aggressive thoughts, resulting in evidence that probiotics may help reduce negative thoughts associated with sad mood (Brain Behav Immun. 2015 Aug;48:258-64).

Research involving 15 human studies discovered patients who supplemented with Bifidobacterium and Lactobacillus strains for one to two months experienced improvements in anxiety, depression, autism, obsessive-compulsive disorder and memory, including spatial and non-spatial memory, showing the efficacy of probiotics on central nervous system function (J Neurogastroenterol Motil. 2016 Oct 30;22(4):589-605).

In a study of 40 patients with depression, individuals who took probiotic supplements also reaped benefits. Taking probiotic supplements for eight weeks decreased depression levels and reduced levels of C-reactive protein (a marker of inflammation) and hormones such as insulin, compared to people who did not take a probiotic (Nutrition. 2016 Mar;32(3):315-20). After the eight-week intervention, patients who received probiotic supplements had significantly decreased Beck Depression Inventory total scores.

Read The Full Article HERE

IP trends in sports nutrition

Patent filings directed to sports nutrition continue to generally grow year over year. The trend is particularly pronounced on a global scale.

The increase in patent filings (through 2016) of sports nutrition products has been occurring outside the United States, with a large portion of filings in China. Brazil and Russia, which are not usually on the top filer lists, have weighed in with a significant amount of patent filings specifically associated with sports nutrition.

Sports nutrition ingredients may be formulated into food products, such as modified foods or complete food formulations. Alternatively, specialized ingredients may be incorporated into single or multi-ingredient nutritional supplements. To be patentable, these types of formulations must include a unique non-naturally occurring single ingredient or a previously unknown combination of ingredients, among other innovative features.

Trademarks for sports performance products include some expected terms like “sport,” “perform,” “strong” and “fast.” Since these terms are common, they cannot be registered in trademarks on their own. Common terms and variations thereof must be coupled with more distinctive terms to obtain trademark registration.

Careful consideration is required to determine if a particular combination is available. Trademark availability searches from trademark counsel can help find a potential trademark that does not encroach upon the rights of a third party’s trademark.

Finally, a steady increase in the term “performance” may indicate the sports nutrition performance field is still growing. Opportunities still exist for innovative products and brands to carve out their exclusive rights in an exciting area of nutritional products.

This is an excerpt from the article, “Intellectual property trends in sports nutrition.” To read the complete article, download the Sports nutrition: Performance digital magazine.

Read The Full Article HERE

FDA still finding same cGMP deficiencies at dietary supplement facilities

FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.

In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs.

Warning Letters

There may be another silver lining. Data analyzed by the Natural Products Association(NPA) suggested an increasing number of firms cited in Form 483s for failing to establish product specs make the necessary corrections without requiring an admonishment from FDA in a subsequent warning letter.

NPA, a trade association founded in 1936 and led by former FDA officials, reviewed FDA warning letters to analyze alleged infractions of the cGMPs.

In reviewing the data dating back to 2010, NPA identified a change in the most cited cGMP violation. Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).

In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

Read The Full Article HERE

FDA’s new nutrition label regulation for fat-soluble vitamins

The international unit (IU) has been used to measure fat-soluble vitamins—vitamin A, D and E—for decades. The IU is an arbitrary amount based on the amount of a given nutrient needed to produce a biological effect. Different than milligram or microgram, the IU measurement describes something that we cannot see; the potency or biological activity of a product. While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

In the new regulation for the nutrition facts label, FDA is replacing the unit “IU” for vitamin A, vitamin D and vitamin E with the metric unit. The unit for vitamin A will be changed to micrograms of retinol activity equivalents (mcg RAE), milligram of alpha-tocopherol (mg) for vitamin E while Vitamin D will be changed to microgram, while the IU reading for Vitamin D could be displayed in parentheses. This regulation will come into effect on Jan. 1, 2020 for companies with US$10 million or more in annual sales; and Jan 1, 2021 for companies with less than $10 million in annual sales. It is expected that other countries will follow this new regulation as well to standardize the labelling system. This new supplement/ nutrition facts label hopefully will help consumers to make a better decision in terms of choosing the right vitamin A and vitamin E for their daily consumption.

Vitamin A

Vitamin A is essential vitamin for healthy vision and cellular communication. There are two main ways to obtain vitamin A in the diet, through:

(1)         retinols from animal sources and dairy products;

(2)         pro-vitamin A carotenoid from plant.

Both retinols and pro-vitamin A carotenoid are metabolized in the body into the active form of vitamin A, retinoic acid. However, retinols and pro-vitamin A carotenoid differ in their bioactivities. As an example, it takes different amount of IU from retinol, beta-carotene from food, beta-carotene from supplement or alpha-carotene to make 1 microgram of retinoic acid.

Therefore, it is vital for consumers to check the source and forms of vitamin A to ensure they get sufficient vitamin A according to the recommended dietary intake (RDI). The RDI of the vitamin A has also changed from 5,000 IU (equivalent to 1,500 mcg RAE) to 900 mcg RAE for males and 700 mcg RAE for females respectively.

The conversion of unit of vitamin A from IU to the metric unit, mcg RAE, will take into account the differences in vitamin A activity between retinols and pro-vitamin A carotenoid. In the new unit, 1 RAE will equal to 1 mcg retinol, 12 mcg beta-carotene, 24 mcg alpha-carotene or 24 mcg beta-cryptoxanthin. Hence, the change of IU to mcg RAE for vitamin A is welcomed as this will reflect the actual or reality of vitamin A activity of its different forms—retinol and pro-vitamin A carotenoid.

Read The Full Article HERE

The relationship between sleep aids and stress management

Sleep aids are rapidly growing in popularity across the globe, posting a compound annual growth rate (CAGR) of 6.5 percent between 2012 and 2017 to reach retail sales of US$2.3 billion in 2017, according to market research firm Euromonitor International. Driven by an increasingly stressed and sleepless consumer base, particularly in the developed world, sleep aids are expected to continue growing through 2022.

Stress and sleep management are essentially one in the same when looking at consumer response: lack of sleep leads to increased stress, which results in an increase in reported sleeplessness. As a stressed consumer base turns to over-the-counter (OTC) sleep aids for relief, products positioned to address both conditions will continue to grow in popularity.

Sleep Aids Among Fastest-Growing OTC Categories

Though retail sales of sleep aids amounted to just $2.3 billion in 2017—far below cough, cold and allergy remedies, which is the largest OTC category—sleep aids experienced strong growth over 2012-2017, second to emergency contraception, which posted a CAGR of 9.4 percent over the same period. Looking forward, sales of sleep aids are expected to post a CAGR of 2.6 percent globally through 2022, according to Euromonitor.

Sales of sleep aids are heavily affected by demographic and epidemiological factors, particularly in the developed world as consumers increasingly report higher levels of work- and family-related stressors as well as a decline in number of hours slept each night. As stress levels continue to increase, consumers will likely continue to turn to OTC sleep aids for relief.

Increasing Stress Levels

The most common sources for consumers’ increasing stress levels are their jobs, familial obligations and, often, pressure from peers or society to work harder and accomplish more to achieve perceived success. Surveys of consumers’ attitudes toward work/life balance and stress management activities indicate across global markets (though largely excluding the developing world), consumers report being more stressed and under more perceived pressure in 2016 than in previous years, and there is every reason to believe these attitudes will persist and strengthen in the coming years as well.

Since the market for sleep aids is tied so closely to stress management, any discussion of retail sales of products to promote sleep must necessarily include a discussion about the psychological health of the consumer base and their motivations for buying sleep aid products in the first place.

Read The Full Article HERE

Body boosting ingredients for the serious athlete

Branched chain amino acids (BCAAs) are incredibly popular with hardcore athletes and body builders. BCAAs include leucine, isoleucine and valine, which are essential amino acids that humans only get from food and beverage because the body doesn’t make them on its own. Among the benefits of BCAA products  are stimulation of muscle protein synthesis (MPS), prevention of muscle breakdown and delaying of muscle fatigue.1

There are hundreds of BCAA products on the market, and some of the most popular brands include Cellucor, BPI Sports and Dymatize. BCAA supplements are most often sold as powders with sweet and citrus flavors, but brands such as Optimum Nutrition and Scivation have developed ready-to-drink (RTD) beverages, as well.

Collagen is the most abundant protein found in the human body and is the basis of connective tissues that help give structure to tendons, ligaments, skin, bones and teeth. It is also sold as a supplement in products that are rapidly growing in popularity. The ingredientworks with endogenous hyaluronic acid (HA) to improve joint health,2 enhance hair,3 skin4 and nails.5 As a bonus, it may also help repair muscle tissue, although whey and casein are generally regarded as more effective for that purpose.6

The source of the collagen isn’t quite so sexy. It comes from animals such as cattle, fish, turkeys and chickens, which means it is not vegan and can cause issues with a product’s kosher status. Allergenic concerns also need to be taken into consideration for sensitive consumers. Formulating with collagen can be challenging because it can have solubility issues, but brands such as Eviva Collagen Elixir, Beauty & Go and Pure Gold Collagen have successfully developed RTD collagen supplements. Many collagen protein powders are on the market, as well, including in  brands such as NeoCell, Ancient Nutrition, Vital Proteins and Sports Research.

Micellar casein is an up-and-coming ingredient for active consumers and is generally regarded as the most effective form of casein compared to similar ingredients like calcium caseinate. It is the slowest digested caseinate protein and is a source of high-quality BCAAs and glutamine.

“The mechanism of action is a stark contrast to hydrolyzed whey, which is known for fast-acting, quick absorption into the body,” explained Jason Dompeling, beverage scientist at Imbibe. “Micellar casein is known for very slow absorption. The casein micelles form a sort of ‘clot’ in the gastrointestinal (GI) tract that slow down the protein breakdown and amino acid absorption.”

Read The Full Article HERE

Product offerings grow for the anxiety, stress, mood and sleep category

Qualifying and quantifying the market for products that address anxiety, stress, mood and sleep is a little like trying to nail jelly to the wall or define “obscenity.” Regarding the latter, U.S. Supreme Court Justice Potter Stewart famously remarked in 1964 that “I know it when I see it” to describe his threshold test in Jacobellis v. Ohio. To some extent, this also applies to the market for products that address anxiety, stress, mood and sleep.

Products addressing anxiety, stress, mood and sleep are scattered all over the marketplace. No longer are innovation opportunities limited to over-the-counter (OTC) medications and dietary supplements.

GlobalData identified product innovation oriented around anxiety, stress, mood and sleep that spans nearly 30 different product categories. Product manufacturers are addressing these needs in categories as diverse as fruit, chocolate, yogurt and beer, to air fresheners, fabric conditioners, facial-care products and more.

Companies far and wide want a piece of the pie because the pie is big—and growing. GlobalData puts the global market for sleeping aids (classified as OTC health care products) at $US1.36 billion as of 2016. GlobalData expects this market will grow at a compound annual growth rate (CAGR) of just over 4.1 percent for the period from 2015 to 2020. GlobalData puts the U.S. market for sleeping aids at just under $375 million as of 2016, and projects that this market will expand at a CAGR of 3.5 percent for the period from 2015 to 2020.

But trying to measure a market like sleeping aids is not as easy as it used to be, as a growing amount of sleep-related product innovation is taking place outside of OTC health care products and supplements. It is not unusual today to see functional drinks, milk, tea, food products and even facial-care products promote enhanced sleep. Even within OTC medications, sleep aids have become a moving target as companies attempt to monetize interest in more natural and holistic formulations.

Read The Full Article HERE

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.

Read The Full Article HERE

Sports nutrition retail shift offers growth opportunities to brands taking new approaches

Let’s face it: the world feels like it is changing faster and more aggressively than any other time in recent history. In the sports nutrition industry, iron-clad brands are now showing cracks in their armor. This is especially true for legacy sports nutrition brands.

These brands are feeling the squeeze to stay relevant against an onslaught of emerging competitors that have entered the market due to today’s lower barrier of entry. Over the past decade, the increasing popularity of e-commerce has made it easier for brands to sell their products directly to consumers. This direct connection has given rise to a plethora of sports nutrition startups, that are in turn fragmenting the market and fundamentally changing how consumers purchase products.

Gone are the days of generating a reliable, perpetual growth trajectory through the previous sales and marketing models that fueled decades of industry success. These legacy sports nutrition brands now face pressure as consumer behaviors shift and the channel landscape changes. To win in the coming years, sports nutrition legacy brands need to reduce their reliance on and diversify their offline channels. Despite sports nutrition products being a relatively difficult category for consumers to shop for online without prior product knowledge, online sales continue to dramatically increase.

This increase of the self-directed consumer has given online retailers like Amazon a further cognizance to invest in the category. Simply put, the main question pondered by most legacy sports nutrition brands is not whether they should have an e-commerce presence, but rather what level of presence they need to grow. Regardless, the sooner legacy sports nutrition brands start building an e-commerce strategy, the better they will be able to compete with more agile, digitally native challengers.

Read The Full Article HERE

Researched ingredients with anti-inflammatory effects

• Short-term inflammation is a protective response, but chronic inflammation can have a negative effect on the human body.

• Palmitoylethanolamide (PEA), Terminalia chebula, grape seed extract and magnolia are among the options for formulators.

• The anti-inflammatory market is projected to reach US$130.6 billion by 2026 with a CAGR of 8.5 percent from 2018 to 2026.

Inflammation is one of the body’s natural defense mechanisms, addressing hazardous stimuli such as tissue damage or allergens. On a short-term basis, inflammation can help the body return to a healthy state. However, according to a 2016 review, “Uncontrolled inflammatory response is the main cause of a vast continuum of disorders including allergies, cardiovascular dysfunctions, metabolic syndrome, cancer and autoimmune diseases.”1

While various pharmaceuticals are available to help control and suppress inflammatory crisis, the potential for side effects and the desire for a natural course of action lead many consumers to seek alternative solutions. The review noted several herbs with anti-inflammatory effects that have been evaluated in clinical and experimental studies, including Curcuma longa (curcumin), Zingiber officinale (ginger), Rosmarinus officinalis (rosemary), Borago officinalis (borage), evening primrose and devil’s claw. It also mentioned, “the treatment of inflammation is not a one-dimensional remedy,” and therefore, suggested “a multidimensional therapeutic approach to inflammation with the help of herbal medicine and modification in lifestyle.”

Blake Ebersole, president of NaturPro Scientific, pointed to palmitoylethanolamide (PEA) as an emerging anti-inflammatory ingredient that’s been studied in large trials in Europe. It’s a peroxisome proliferator-activated receptor-alpha (PPAR-α) ligand that exerts anti-inflammatory, analgesic and neuroprotective actions.2 A 2014 review noted PEA was first identified as an anti-inflammatory compound more than half a century ago, but greater exploration didn’t occur until the mid-1990s. PEA was shown to reduce tumor necrosis factor (TNF)-α in lipopolysaccharide (LPS, a pro-inflammatory endotoxin)-induced pulmonary inflammation in mice, as well as mast cell degranulation and edema formation in various inflammatory models.3

The review mentioned more recent investigation of the anti-inflammatory mechanisms. PEA inhibited phosphorylation of kinases involved in activation of pro-inflammatory pathways, and the nuclear translocation of nuclear factor-kappa beta (NF-κβ) and activator protein 1 (AP-1), as well as preventing degradation of the inhibitory IκB-α, which when associated to NF-κβ prevents its nuclear translocation.4,5

Read The Full Article HERE

dcl-made-in-usa
dcl-fda
dcl-gmp-certified
Nutracap-Organic-Seal
Nutracap-asi
halal

For more information call (800) 688-5956 or Contact Us for a Free Quote!

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!