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Omega-3 sources for supplement differentiation

At one time, cold water fish was the predominant source for omega-3 fatty acids, but “fish burp” pushbacks, and calls for more sustainable and vegetarian alternatives have given rise to a marketplace flourishing with choice—which can be simultaneously as wonderful as it is confusing to consumers. For omega-3 brands, playing up a product’s unique ingredient origin can help unlock elusive on-shelf differentiation, regardless of whether the product hails from fish, krill, algae, ahiflower, calamari or flax.

To be clear, consumers have a healthy interest in fish-origin docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).Chris Gearheart, director, member communications and engagement, the Global Organization for EPA and DHA Omega-3 (GOED), said the market for those ingredients has grown at least 2% in volume and value for each of the last three years, according to the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. However, the overall market is being shaped by two forces: mass market activity and interest from new users.

Eric Meppem, co-founder, Pharmako Biotechnologies Pty Ltd., said the mass market has been commoditized. “Pundits state the market is flat or shrinking, but due to lower retail prices and larger pack size, actual omega-3 use is rising,” he said, adding that the factors are causing margin pressure throughout the supply chain.

New, emergent users typically embrace new omega-3 sources or delivery systems. “In most markets, these are more specialized, but mass-market brands are now considering these, wanting to broaden their offerings and combat margin squeeze,” he explained.

Top drivers behind interest in newer omega-3 sources include bioavailability and absorption, as well as ecological concerns like sustainability from sea-origin ingredients.

Organic Technologies, producer of AlaskOmega omega-rich fish oil products, begins with wild-caught Alaska pollock oil from Alaska’s Bering Sea. Steve Dillingham, vice president of sales and marketing, said the expansive U.S. Alaska pollock fishery is responsibly managed, with less than 1% bycatch and certified 100% sustainable and traceable by the Marine Stewardship Council. AlaskOmega oils are also certified sustainable through the Marine Stewardship Council chain-of-custody program, considered the gold standard by the industry.

Kate Pastor, senior vice president, Superba North America, Aker BioMarine Antarctic US LLC, said she believes ongoing investments in science and innovation are contributing to the vibrancy of the krill oil market. Aker BioMarine recently announced that it would be exploring krill oil’s potential benefit in new areas of study, including sports nutrition, skin health and Lupus.

“More novel sources of EPA and DHA omega-3s like greenshell mussel, hoki and calanus have seen double-digit growth in volume and value recently, but they are starting from a much smaller base,” explained GOED’s Gearheart, based on the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. “Some of these unique ingredients appeal to Chinese consumers, for example, because they are especially interested in products from certain geographic regions—mussel oils come largely from New Zealand, [and] calanus saw most of its growth in the U.S. and Europe, where consumers may be drawn to the chance to revisit omega-3 consumption in a novel way.

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FDA’s limited view of inflammatory claims

Sports and other physical activities involve strenuous use of muscles, tendons, ligaments and such, leading to inflammation of the tissues and joints. Our own physiology gives us the ability to address this inflammation. We possess a system that deals with inflammation, known as the cholinergic anti-inflammatory metabolic pathway. It carries signals to and from cells in response to inflammation.

Keeping this system in good health is a good idea, but it can be challenging for natural product brands to communicate how products or ingredients can aid in this effort due to the regulatory realities of structure/function claims.

In the initial years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the requirement to notify FDA of intended structure/function claims meant brands sent claims to Center for Drug Evaluation and Research (CDER) for evaluation. This drug branch of FDA was not an appropriate place for review of this newly formed class of claims, but that was the reality. Claims involving inflammation were submitted, and the general concept of addressing inflammation with supplementation was allowed (by virtue of no written objections to such claims). In the rulemaking discussion, inflammation claims in joints was noted as off limits, but not anti-inflammatory actions of the body generally.

However, about five years ago, FDA alerted the industry that it determined inflammation claims in nearly all instances constitute a drug claim. The agency reasoned the anti-inflammatory system of the human being is not always active. This contrasts the immune system, which is always active. Thus, claims involving support of a “system” that is always turned on are allowed but supporting a “system” that turns on in response to dysfunction and/or damage involves a pharmaceutical action. FDA made an exception where inflammation and discomfort are occasional and the result of strenuous exercise. Exercise apparently does not cause damage or render any part of the body dysfunctional regardless of how strenuous the exercise, though I have some personal stories to the contrary.

Ingredients used in dietary supplements are substantiated to benefit or reduce inflammatory processes. That is a truth. The basic standard for claims is that they be “truthful and not misleading” per the Federal Food, Drug, and Cosmetic Act (FD&C). Substantiation is the legal and regulatory requirement to meet this standard. When this is in place for inflammation claims, however, other standards come into view. This narrower finding by FDA is simply that: a finding. It is not a regulation. It is not guidance on the topic nor is it published as official. However, FDA has emphasized statements such as “supports healthy inflammation response” are unauthorized. This is owed to inflammation being considered a dysfunctional state. When it is the result of something not vector-driven (disease) or injury-caused (damage), the inflammatory response is a result of something other than normal, which is the standard for which dietary supplements are intended to benefit. Where these boundaries are drawn is blurred and not adjudicated. Regardless, without continual challenge to these soft boundaries, the interpretation of the law by the agency about claims remains an ever-shifting and narrowing landscape as shown by the anti-inflammation issue.

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Nootropics for healthy cognitive function

People in many countries, including the U.S., are experiencing an increased life span.1 However, the aging population aims not just for increased, but optimized, years of life. Paramount to this are strategies to improve cognition or delay age-related cognitive decline. Supporting cognitive function is something that can, and should, be considered, even before the earliest signs of dementia are noticed.

Nootropic, a term coined in 1972 by Corneliu E. Giurgea, Ph.D, refers to a nontoxic substance that enhances learning and memory, facilitates communication between the brain hemispheres and enhances neurological resilience.2 Nootropics are commonly utilized to prevent or support early states of cognitive decline; they are also utilized by those who simply wish to optimize their cognitive function.

Cognitive function can be enhanced in a variety of ways. Studies show high levels of free radicals in the brains of those with cognitive decline.3 Antioxidants that can cross the blood-brain barrier tend to support cognitive function and protect the brain from the expected effects of aging. Vasodilators increase blood perfusion to the brain, enhancing oxygen levels and aiding glucose utilization.4 Substances that support neurotransmitter levels, particularly acetylcholine (ACh), can treat dementia.5 Finally, substances that support neurogenesis and increased neurological plasticity via modulation of brain-derived neurotrophic factor (BDNF) show great promise in enhancing cognitive function.6

Ginkgo bilboa (ginkgo) leaf is a well-known nootropic herb. Ginkgo trees belong to the Ginkgoaceae family, an ancient family cultivated for thousands of years for medicinal use in China. Much of the ginkgo used in research studies is a standardized product (EGb 761) of 22 to 27% flavonol glycosides, 5-7% terpene lactones, and less than 5 ppm ginkgolic acids. Ginkgo increases circulation to the brain, supporting glucose levels and adenosine triphosphate (ATP) utilization, and decreasing free-radical damage. Nootropic effects may also be due to increased levels of BDNF.6 Ginkgo is most effective when used for at least six weeks; long-term dosing is safe if the patient doesn’t have a clotting disorder or using anticoagulants (ginkgo thins the blood and should also be discontinued prior to surgery). Adulteration/contamination of ginkgo can be a concern,7 so analysis should be done on ginkgo sources to ensure a high-quality product.

Bacopa monnieri (water hyssop) is an Ayurvedic herb traditionally used as a medhya rasayana (memory/intellectual enhancer). Water hyssop grows in swampy or marshy areas; the arial portion of the plant is used, making it a very sustainable product. Sometimes referred to as brahmi, water hyssop is often contaminated with Centella asiatica.8 Water hyssop is a potent antioxidant that can cross the blood-brain barrier. Administration is protective against toxic exposure, including tobacco and common environmental contaminants with neurotoxic side effects.9,10 Water hyssop also increases cerebral blood flow and supports ACh levels.9 Additionally, early research seems to indicate enhancement of BDNF.6 Multiple studies have shown water hyssop improves memory acquisition and retention, as well as attention and memory processing. Results are most pronounced after three months of administration; short-term memory improvements are not seen in research studies, although many patients feel subjectively better even with short-term administration.

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IP trends in sports nutrition

01_23 Anthony Arteca sports nutrition blog_0

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

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