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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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Probiotics provide a competitive edge in sports nutrition

The gut flora performs a variety of functions that are important for health. In fact, 70 percent of the body’s immune cells are located in the digestive tract, making gut health critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects against pathogens, provides vitamins and nutrients, and helps form the immune system. For athletes and fitness enthusiasts, optimizing digestion and immunity are major factors as they strive to improve performance. As research advances, probiotics will play a leading role in shaping the sports nutrition supplements of tomorrow.

Athletes and active individuals have high nutrient needs, which are best met when digestion is well-functioning. Healthy bacteria in the gut aid in the digestion of macronutrients, allowing for optimized nutrient uptake from an athlete’s diet. They also aid in the digestion of macronutrients, allowing for optimized nutrient uptake from the diet. Some probiotic strains can play a role in the use of protein for muscle growth and human recovery by promoting the absorption of key amino acids. Being able to absorb more of the amino acids from protein can help increase muscle growth. In addition, probiotics can support immune health by adhering to the gut epithelium, thereby enhancing the “gut barrier” function of those cells by preventing the adhesion of pathogens.

Working out is all about breaking down and rebuilding muscles to become stronger and faster. With such activity, inflammation and free radical production are normal, expected and necessary—but the body’s response to these reactions will determine how quickly an athlete can recover and get back to his or her regimen. The two main areas of focus while doing strenuous activity are providing the right nutrients to build muscle (protein) and recovery (reduced inflammation). Probiotics can help in both of those areas; for example, the strain Bacillus subtilis DE111® (from Deerland) produces many enzymes to help break down protein, and recent research supported its role in reducing markers of inflammatory compounds that arise during exercise (Sports. 2018;6[3]:70).

According to the National Collegiate Athletic Association (NCAA), there are more than 480,000 NCAA student athletes who compete in 24 sports every year. And of course, this is only a slice of the physical-competition pie. Add professional sports, athletic trainers and serious fitness enthusiasts like marathoners and cyclists, and the number of individuals who could benefit from probiotic supplementation is significantly higher.

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Sugar reduction in sports nutrition applications

The sports nutrition market continues to see steady growth. Athletes and mainstream users, including exercisers and those leading active lifestyles, are looking for products that support their recreational and lifestyle-driven performance. Both men and women seek sports nutrition products to help improve their nutritional intake, general health, well-being, performance, and muscle growth and recovery from exercise. The success of sports nutrition products requires meeting consumer demand with formulations they can trust and rely on, while also delivering on taste. Whether protein powders or bars, gummies, chews, ready-to-drink (RTD) beverages, pre-workout enhancers or post-workout enhancers, flavor and sweetness must meet consumer expectations.

Clean label and free-from claims

Many active consumers are looking for clean label products, including those with no artificial colors, flavors or sweeteners, and other “free-from” claims. There is a clear shift toward plant-based, natural, sugar-free and less-added-sugar products. Sugar reduction innovation is at an all-time high, and there is tremendous demand for sweeteners that allow for 100 percent sugar replacement—and are also natural and taste good. However, consumer preference for sweetness is still strong, too. Sports nutrition product manufacturers are actively seeking ways to successfully achieve low sugar content while delivering on good taste, texture and overall appeal.

Natural, plant-based sweeteners

The demand for sugar reduction and product purity has brought much attention to natural and plant-based sweeteners such as stevia and monk fruit. Stevia has led the natural high-intensity sweetener market, and demand has grown exponentially since its approval and introduction. Monk fruit, also known as luo han guo, is quickly rising in popularity. Many sports nutrition brands are recognizing the benefits of incorporating monk fruit into products and formulations, and it is garnering attention as a sugar alternative. The sweetness of monk fruit comes from components called mogrosides found in the flesh of the fruit. Monk fruit is a no-calorie, natural sweetener with a glycemic index of zero that provides a well-rounded, fruity taste profile, and allows for an added “fruit-based” claim.

Finding the sweet spot

Formulating sports nutrition products that meet these needs may require manufacturers to address significant technical challenges. Reducing sugar content can impact not only sweetness, but also texture, color and the overall taste experience. While athletes and other sports nutrition consumers are looking for healthier alternatives and less sugar, they are also not willing to give up taste. Mintel reported taste is the most important product attribute to consumers. For this reason, reducing sugar in sports nutrition products cannot be done at the expense of flavor and familiarity.

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FDA issues guidance on disclosing amount of live microbial ingredients in supplements

FDA on Thursday recognized the benefits of disclosing on labels the number of live microbials in dietary supplements—an issue of interest to marketers of probiotics.

FDA stopped short of amending its labeling regulations, denying a request filed by the International Probiotics Association (IPA).

However, the agency revealed plans to “exercise enforcement discretion” for companies that chose to declare on the Supplement Facts label the amount of live microbial ingredients based on colony-forming units (CFUs), in addition to disclosing the quantitative amount of certain dietary ingredients based on their weight per FDA regulations.

“We believe that CFUs provide a useful description of the quantity of live microbial dietary ingredients,” FDA explained in a constituent update. “Allowing firms to declare the CFUs within the Supplement Facts label will help consumers more readily identify the amount of living microorganisms for each product and more easily compare products.”

Enforcement discretion

In draft guidance published Sept. 6, 2018, FDA said it intends to exercise its enforcement discretion, provided the following conditions are met:

• The quantity is first listed in terms of weight;

• The declaration of quantity in CFUs is expressed in a manner that is clearly separate and readily distinguishable from the weight, e.g., as a parenthetical or in a subset line;

• The declaration of quantity in CFUs is formatted in clear terms that can easily be understood by a common reader, e.g., 10 billion or 300* (where the unit that “*” is intended to represent, such as million or billion, is a typical measurement of CFUs and is clearly indicated elsewhere in the Supplement Facts label)

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FDA Expands List of Ingredients Approved as Dietary Fiber

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released decisions made on citizen petitions to expand and better define what ingredients fall under the legal definition of “dietary fiber.”

When in 2016 FDA unveiled a new definition for dietary fiber as part of updating the final rule for the Nutrition Facts label, the agency specified this term referred to “naturally occurring fibers like those found in fruits, vegetables, and whole grains, and seven isolated (i.e., extracted from plant sources) or synthetic non-digestible carbohydrates (NDCs), each having a physiological health benefit.”

FDA solicited citizen petitions for isolated or synthetic NDCs outside of this initial list of ingredients, if scientific evidence demonstrated a beneficial physiological effect on human health.

Notably, several common non-digestible carbohydrates, such as the popular ingredient inulin, were omitted from the initial definition, leaving suppliers left to wonder whether these ingredients would be included as a dietary fiber on the Nutrition Facts label.

With the announcement of the new rulings from Commissioner Scott Gottlieb, eight new fibers were added to the list, including:
mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others);

-arabinoxylan;
-alginate;
-inulin and inulin-type fructans;
-high amylose starch (resistant starch 2);
-galactooligosaccharide;
-polydextrose;
-resistant maltodextrin/dextrin.

“Consumers can be assured that non-digestible carbohydrates counted as fiber on the new Nutrition Facts label have health benefits grounded in scientific evidence,” commented Commissioner Gottlieb. “Eating foods rich in dietary fiber, as recommended by the Dietary Guidelines for Americans, can help cholesterol levels, increase feelings of fullness (satiety) resulting in reduced calorie intake, and increase the frequency of bowel movements.”

He also noted the list of dietary fibers could expand, looking ahead. “We are taking a flexible approach to dietary fiber, allowing for the possibility of additional fibers to be added to the list of those meeting our dietary fiber definition if the scientific evidence shows they are physiologically beneficial,” he said.

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CRN Voluntary Guidelines Reinforce Industry Commitment to Consumer Safety

The Council for Responsible Nutrition (CRN) has unveiled two developments in its collection of proactive, science-based voluntary guidelines and best practices: new recommended guidelines for products containing SARMs and updates to its recommended guidelines for caffeine-containing dietary supplements.These updates coincide with recent FDA action to protect consumers from the potentially harmful effects of selective androgen receptor modulators (SARMs) and highly-concentrated caffeine.

“CRN’s membership is committed to consumer safety and understands the gravity of going above and beyond what is required by law to ensure their products are high-quality, consistent, and supported by sound science,” said Steve Mister, president & CEO, CRN. “Consumer access to bulk amounts of highly-concentrated powder or liquid caffeine and performance enhancing products containing SARMs are current subjects of sharp industry scrutiny. CRN is grateful for FDA’s recent consumer advisories on these ingredients, as well as for guidance providing clarity to companies attempting to navigate the industry’s strict regulatory framework. CRN’s voluntary guidelines align with FDA’s enforcement actions and help the dietary supplement industry stay on the right side of the law.”

The newly developed guidelines for products containing SARMs stem from increasing concerns raised by FDA, the U.S. Anti-Doping Agency, and the legitimate dietary supplement industry about the dangers of SARMs found in products mismarketed as dietary supplements. Among the many challenges the responsible industry faces with respect to SARMs is the introduction of substances that do not appear to meet the definition of a dietary ingredient as outlined by the United States Federal Food, Drug, and Cosmetic Act; fail to provide proper notification to FDA as new dietary ingredients (NDI); and appear to lack scientific evidence supporting safety. Coinciding with FDA’s position that products containing SARMs do not meet the definition of a dietary supplement, CRN’s guidelines recommend that responsible firms should not distribute or market products containing these ingredients.

CRN’s guidelines for caffeine-containing dietary supplements, originally created in 2013, recommend that companies disclose the amount of caffeine in a dietary supplement, provide label advisories about safe use of such products, and refrain from sale under certain conditions. The guidelines were updated in 2015 to institute restraints against the sale and marketing of bulk amounts of pure or highly-concentrated caffeine in powder form, and the 2018 revisions expand these restraints to also include concentrated liquid forms, as outlined by an FDA guidance released earlier this year.

“CRN trusts that the dietary supplement industry will adopt these two sets of crucial guidelines into its standard operating procedures,” surmised Mr. Mister. “As the marketplace continues to grow and innovate, we lend our full support to FDA’s proactive enforcement efforts to improve consumer safety and industry accountability.”

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FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

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