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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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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.

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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.

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Marine Ingredients: Sourcing from the Sea

Virtually all scientists believe that life on Earth originated in the sea billions of years ago. If one accepts this premise, it comes as no surprise that the sea and other waters of the world continue to produce natural ingredients that enhance health and contribute to an active, vibrant lifestyle.

The first, of course, is fresh water itself, which humans need for drinking and to provide—via evaporation, rain, and irrigation—the moisture needed to nourish vegetation, forestation, and cultivated crops. Within the foreseeable future, it’s possible people will use the salted sea for the majority of drinking water, too, thanks to desalinization efforts around the globe.

Other health-giving substances from the sea include many thousands of varieties of plant and animal matter that grace dinner tables, providing essential macro- and micronutrients. And then there are specialized oils, extracts and more that have become critical components of the marine ingredients segment of the broader nutraceutical industry.

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Krill oil for heart health

The market for heart health supplements is thriving. According to Nutrition Business Journal (NBJ) data, the market for heart health ingredients has the potential to reach more than US$3 billion by 2020. With that in mind, there are many options for consumers seeking out heart health products.

Omega-3s are considered a strong contender in this market. In fact, research has shown long-chain omega-3s support healthy blood pressure and cholesterol levels, normal blood clotting processes, as well as a regular heartbeat, all of which contribute to keeping both the heart and its arteries healthy.1,2 The anti-inflammatory nutrients found in omega-3s can help balance the body’s level of inflammation, promoting overall health and wellness.3

Every person’s omega-3 needs are different and the amount of EPA and DHA one would need to take to raise their Omega-3 Index into the target range will vary. Not all omega-3s are created equal. They vary in structure and function, and only marine-based omega-3s (or long-chain omega-3s) contain EPA and DHA.

Krill oil provides EPA and DHA mainly in the form of phospholipids. The body immediately recognizes phospholipid omega-3s and incorporates them into the cells before carrying them to the tissues and organs that need them the most, such as the heart. On the contrary, other sources of omega-3s are delivered as triglycerides and must be processed in the liver before they can be taken up by the cells and used by the body. Therefore phospholipid-bound omega-3s, like krill oil, raise one’s omega-3 index more efficiently as compared to other omega-3 oils.4

In addition to omega-3 fatty acids EPA and DHA, krill contains the essential nutrient choline, which is crucial for cell structure, function, and signalling.5 Choline is found to positively contribute to cardiovascular, liver and cognitive health. Furthermore, the astaxanthin found in krill oil helps keep its omega-3s naturally fresh and stable.

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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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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.

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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.

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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.

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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.

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