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This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.IntroductionInnovation grows industries, and it is no different for the dietary supplement industry. Estimated US sales for the industry reached $48.8 billion in 2019 and its growth has hovered around 5%-6% in recent consecutive years.1 Some of that success is likely attributable to innovation of products. New products, in part, emerge from formulations of new dietary ingredients (NDIs), which are ingredients that came to market after 15 October, 1994, in accordance with the Dietary Supplement Health and Education Act (DSHEA). Under the law, marketers must affirm the safety of an NDI and submit a detailed notification for review by the United States Food and Drug Administration (US FDA) at least 75 days before the NDI becomes accessible to consumers.2Since the enactment of DSHEA, the number of supplement products on the US market proliferated from 4,000 to around 80,000 in 2019, according to FDA estimates,3 and the agency has received just over 1,100 NDI notifications.4 Diverse companies have submitted NDI notifications for numerous botanical-derived ingredients, such as sea buckthorn extract, algal DHA, astaxanthin, huperzine A, and resveratrol. Other notified NDIs comprise microorganisms, including various species of Bifidobacterium (bifidum, breve, lactis, longum) and Lactobacillus (acidophilus, bulgaricus, casei, fementum, reuteri, rhamnosus, plantarum) and their various strains; enzymes, such as peptidase, pepsin, and seaprose; and a host of dietary substances from conjugated linoleic acid to krill oil to zeaxanthin.4The statistics indicate it is possible that notifications have not been submitted for all NDIs on the market. There may be many reasons for that, including a lack of clarity on exactly what an NDI is and in which cases an NDI notification must be filed (there are exemptions to the notification requirement). Industry and FDA have expressed differing views on these and other NDI-related issues since 2011,5-9 when the agency issued a draft guidance on NDI notifications, and even after the draft guidance was revised in 2016.10Although FDA does not have final guidance in place, it recognizes that NDI notification issues may present obstacles to dietary supplement innovation and proclaims the agency is examining new approaches to NDIs.11Intellectual property incentiveFDA should consider intellectual property protection as it explores incentives for companies to submit NDI notifications. Development of new ingredients requires substantial investment. Significant resources go into establishing a manufacturing process that produces a consistent, stable ingredient and generating scientific data to support the safety of the ingredient under the intended conditions of use. Companies making these investments want assurance that they can protect NDI-related intellectual property throughout the notification process, and long after, to have a competitive edge in the marketplace as a return on investment.

A master file is an elective submission to FDA that contains data deemed proprietary by a company, such as a drug ingredient manufacturer.12 The master-file submission procedure is already used extensively in the drug industry. Adding a master file component to the NDI notification process could protect the intellectual property of NDI manufacturers and facilitate the supplement industry and FDA in fulfilling NDI-related goals and, ultimately, promote consumer access to safe dietary supplements.Drug companies submit master files for a myriad drug components, including active pharmaceutical ingredients (APIs) and packaging; these drug master files (DMFs) are referenced by multiple sponsors in the context of new drug applications (NDAs) and other applications. The DMF owner, or holder, has the discretion to authorize any third party to reference its DMF by issuing a letter of authorization (LOA). LOAs, along with a list of authorized parties, are submitted with the DMF.

This authorization permits the authorized party to reference the master file, but not to review its contents, and FDA reviews the relevant parts of the master file in accordance with the LOA. Implementation of the DMF has allowed API manufacturers, for instance, to protect intellectual property related to their APIs, while seamlessly facilitating the drug approval process by reducing the need to submit information of the same type across different NDAs. In Canada, natural health product master files (NHP-MF) are commonly referenced in product licensing applications. The NHP-MF submission procedures and requirements are similar to those for DMFs in the US.As with drug and natural health product companies, dietary supplement companies could benefit from the addition of the master file to the premarket process, that is, the NDI notification. Implementation of an NDI master file (NDI-MF) system avails dietary ingredient manufacturers of the option to seek protection of intellectual property generated through research and development of an NDI, such as information regarding manufacturing, processing and safety.

Once the NDI-MF has been submitted to FDA, it may be referenced, with permission from the NDI-MF holder, by those submitting NDI notifications. The entire NDI notification process is streamlined if NDI-MF data can be referenced by multiple submitters of NDI notifications, and the paperwork burden is reduced because it is possible to submit NDI notifications in an abbreviated manner. An NDI-MF may be referenced by various ingredient manufacturers that desire to include the proprietary NDI in a novel ingredient blend, or by supplement manufacturers that plan to use the proprietary NDI in a new formulation outside the conditions of use established in the NDI-MF. In both hypothetical situations, the NDI notifications submitted to FDA may simply reference the NDI-MF and be abbreviated.It would also be advantageous for FDA to accept master files. The agency would play a vital role in protecting intellectual property and likely face fewer instances of duplicative notifications, which slow down review efficiency, once master files are in place. FDA has responded positively to supplement industry calls to incorporate NDI master files into the NDI notification process.13

In its 2016 revised draft guidance, the agency explains that a company may submit a confidential NDI master file, incorporate the contents of the master file into an NDI notification, and authorize other firms to reference the master file in notifications.14 Furthermore, firms relying on the master file should provide documentation, such as a signed letter, that specifies the relevant parts of the master file included in the authorization. However, although FDA elaborated on the NDI master file concept in guidance, it did not clarify a submission process or how firms might identify existing NDI master files.Industry-proposed framework for NDI master filesExisting and long-standing approaches to master files may be adapted for NDIs. The DMF system has persisted since the 1940s, evolved over time, and served as a model for a framework for the NDI-MF. A supplement industry proposal tailored for NDIs contains all the key elements shared among master file systems, including initial administrative review of submissions and assignment of a master file number by FDA, authorization procedures and requirements, master file updates and closure, and public availability of master file information (Table).Table. Key elements of a proposed NDI master file framework

ConclusionThe NDI-MF is an optional and useful tool for the dietary supplement industry as well as FDA. Other industries have successfully used master files to protect intellectual property. Borrowing from major elements of the DMF, the supplement industry has adapted a framework for NDI-MFs. FDA should consider the industrys proposal and implement a system for accepting and reviewing NDI-MFs as part of NDI notifications to facilitate innovation in dietary supplements.

AbbreviationsAPI, active pharmaceutical ingredients; DHA, docosahexaenoic acid; DMF, drug master file; DSHEA, Dietary Supplement Health and Education Act; FDA, Food and Drug Administration; LOA, letter of authorization; NDA, new drug applications; NDI, new dietary ingredient; NDI-MF, new dietary ingredient master file; NHP-MF, natural health product master file.References

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Integrating master files in the NDI notification process to facilitate innovation in dietary supplements - Regulatory Focus

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The vitamin is needed to regulate the amount of calcium and phosphate in the body.

A lack of vitamin D can lead to serious complications, including osteomalacia, rickets, or some deformities.

But, the symptoms of a vitamin D deficiency can be very difficult to spot.

One of the hidden warning signs of the condition is having severe bone pain, it's been revealed.

READ MORE: Vitamin D deficiency symptoms - what can you smell?

"Severe lack of vitamin D causes rickets, which shows up in children as incorrect growth patterns, weakness in muscles, pain in bones and deformities in joints," said the Cleveland Clinic.

"This is very rare. However, children who are deficient in vitamin D can also have muscle weakness or sore and painful muscles.

"Lack of vitamin D is not quite as obvious in adults.

"Signs and symptoms might include fatigue, bone pain, muscle weakness, muscle aches, or muscle cramps, and mood changes, like depression."

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Vitamin D deficiency: The subtle pain you should never ignore - it could be serious - Express

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LANSDALE Garden of Health, which provides food for those with special dietary needs, held a contactless free food pickup the morning of June 4 at the Lansdale Business Center.

A dozen eggs, a box of USDA produce, a box of Homefree cookies and a box of food from gluten-free food donated by Schr USA was being given to each of the vehicles coming through the drive-through pick up, Garden of Health founder Carol Bauer said.

Enough boxes for 200 pick-ups had been placed out, with additional ones available, she said.

We're prepared for 250, Bauer said.

More than 100 vehicles made pick-ups, the organization later posted on social media.

This is the first time Garden of Health held this type of food distribution, Bauer said.

Hopefully, we'll be able to do it again, she said.

Garden of Health provides allergen-friendly, gluten-free food and fresh produce to more than 25 food pantries and, since the onset of the coronavirus pandemic, has added providing food for community meal programs started or expanded during the pandemic, as well as distributing food to more than 100 private clients in need of special dietary foods, according to a Garden of Health release.

If another drive-through pick up is held, another location will have to be found for it because the Lansdale Business Center space will no longer be available after the middle of June, Bauer said.

We have another tractor trailer of Schr products waiting for us, but their (Lansdale Business Center) space is taken, so we need to find another location that can take a tractor trailer full of food, she said.

The Clemens Food Group donated the use of a refrigerated trailer for the produce and eggs in the June 4 distribution, she said.

Before the start of the food distribution, a $13,500 contribution to Garden of Health was made by the Harleysville Rotary Club.

They're doing excellent work, Gary Volpe, president of the Harleysville Rotary, said about Garden of Health.

He also lauded Bauer's leadership of the organization.

Her heart is incredible and the work she puts forward is also incredible, he said.

Bauer said the Harleysville Rotary has also assisted in other ways, including with volunteer work at Garden of Health's garden in which fresh produce is raised.

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Free food distribution for people with special dietary needs held in Lansdale - Montgomery Newspapers

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Have you ever heard that taking vitamin D supplements or following a ketogenic (keto) diet will protect you from the new coronavirus? In this Special Feature, we explain why these and other persistent myths are not grounded in science.

Even before the World Health Organization (WHO) declared the new coronavirus outbreak a pandemic, their director general, Dr. Tedros Adhanom Ghebreyesus, warned of the danger associated with spreading false information about the virus.

At a conference on February 15, 2020, he declared that were not just fighting an epidemic; were fighting an infodemic.

Fake news spreads faster and more easily than this virus and is just as dangerous, he emphasized.

However, it can be difficult to tell what is credible and what is not given the sheer quantity of information that people are sharing both on and offline.

Previously on Medical News Today, we compiled a list of 28 myths surrounding the new coronavirus (SARS-CoV-2). In this Special Feature, we will take an in-depth look at five more persistent myths and explain why people should not take them at face value.

Some articles claim that if a person takes vitamin D supplements, they will be less likely to contract SARS-CoV-2.

In part, people have based these claims on a controversial paper that appears in the journal Aging Clinical and Experimental Research.

The papers authors claim to have found a correlation between low mean levels of vitamin D in the populations of certain countries and higher rates of COVID-19 cases and related deaths in those same countries.

Based on this correlation, the authors hypothesize that supplementing the diet with vitamin D may help protect against COVID-19. However, there is no evidence to suggest that this would actually be the case.

In a rapid review of the evidence published on May 1, 2020, researchers from the Centre for Evidence-Based Medicine at the University of Oxford in the United Kingdom unequivocally conclude: We found no clinical evidence on vitamin D in [the prevention or treatment of] COVID-19.

They also write that [t]here was no evidence related to vitamin D deficiency predisposing to COVID-19, nor were there studies of supplementation for preventing or treating COVID-19.

Other researchers who have conducted reviews of the existing data surrounding a potential relationship between vitamin D and COVID-19 agree.

One report by specialists from various institutions in the U.K., Ireland, Belgium, and the United States which appeared in BMJ Nutrition, Prevention & Health in May 2020 also points to a lack of supporting evidence in favor of taking vitamin D supplements to prevent infection with SARS-CoV-2.

The reports authors warn that:

[C]alls [for high dose vitamin D supplementation as a preventive strategy against COVID-19] are without support from pertinent studies in humans at this time, but rather based on speculations about presumed mechanisms.

They also note that although sufficient vitamin D can contribute to overall good health on a day-to-day basis, taking supplements without first seeking medical advice can be harmful.

For example, taking too much vitamin D in the form of a dietary supplement could actually jeopardize health, especially among people with certain underlying chronic conditions.

Another widespread rumor is that taking zinc supplements could help prevent infection with SARS-CoV-2 or treat COVID-19.

It is true that zinc is an essential mineral that helps support the functioning of the human immune system.

Starting from this notion, a team of researchers from Russia, Germany, and Greece hypothesized that zinc might be able to act as a preventive and adjuvant therapeutic for COVID-19. Their results appear in the International Journal of Molecular Medicine.

The researchers refer to in vitro experiments that apparently showed that zinc ions were able to inhibit the action of a certain enzyme that facilitates the viral activity of SARS-CoV-2.

However, they also point out the lack of actual clinical evidence that zinc might have an effect against SARS-CoV-2 in humans.

Other papers that cite the potential of zinc as an adjuvant in COVID-19 therapy including one that appears in Medical Hypotheses are more speculative and not based on any clinical data.

In a Practice patterns and guidelines paper from April 2020 which appears in BMJ Nutrition, Prevention & Health nutritionist Emma Derbyshire, Ph.D., and biochemist Joanne Delange, Ph.D., reviewed existing data about zinc (alongside other nutrients) in relation to viral respiratory infections.

They found that, according to available research in humans, zinc supplementation may help prevent pneumonia in young children, and that zinc insufficiency may impair immune responses in older adults.

However, they note that there is not enough evidence about the role of zinc supplementation in preventing viral infections in general.

Rigorous trials [] are yet to determine the efficacy of zinc supplementation, they write.

Vitamin C is another essential nutrient that has received a lot of attention. Many people believe that it can prevent or even cure the flu or common cold.

Although it is true that sufficient vitamin C can help support immune function, current evidence regarding its effectiveness in treating or preventing colds and influenza is limited and often contradictory.

Despite this, there have been claims that this vitamin might help fight infections with the new coronavirus.

It is possible that people are basing these claims on an existing ongoing clinical trial in China, which is looking at the effects of high dose intravenous (IV) vitamin C on hospitalized patients receiving care for severe COVID-19.

The researchers expect to complete the trial by the end of September 2020. No results are available in the interim.

Commenting on the trial, experts from the Linus Pauling Institute which focuses on health and nutrition at Oregon State University in Corvallis explain that although high dose IV vitamin C might help alleviate COVID-19 symptoms in severely ill patients, regular vitamin C supplements are very unlikely to help people fight off infections with SARS-CoV-2.

The experts warn that IV vitamin C is not the same as taking vitamin C supplements, as they would never raise blood levels of this vitamin as highly as an IV infusion would.

They also warn people who may be tempted to up their dosage of vitamin C of the fact they could end up taking too much and experiencing adverse side effects.

Keto diets, which are high in fats and low in carbohydrates, have also received some attention in the context of treating or preventing COVID-19.

This may be because there is some evidence to suggest that keto diets could help boost the immune system. However, much of that evidence is based on animal studies rather than human trials.

Also, an upcoming clinical trial from Johns Hopkins University in Baltimore, MD, proposes to look at whether or not a ketogenic intervention might help intubated COVID-19 patients by reducing inflammation.

The intervention would necessitate the administration of a specially devised ketogenic formula through enteral feeding. It would be a last-resort procedure for those in a critical condition.

There is currently no evidence to suggest that following a keto diet could help a healthy person prevent or treat infection with SARS-CoV-2.

However, there is evidence to suggest that keto diets can expose people to certain health risks such as by raising cholesterol levels. Keto diets may also have side effects, such as flu-like symptoms, headaches, nausea, and changes in blood pressure.

There are also claims suggesting that various herbal medicines might be able to fight off the new coronavirus.

This may partly be based on a statement issued by a Chinese official in April 2020, suggesting that certain herbal drugs could help treat COVID-19, as a communication in The Lancet on May 15, 2020, reports.

Author Yichang Yang from the Department of Traditional Chinese Medicine at the Second Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou, China warns that people should take encouragements to use herbal remedies in the treatment of COVID-19 with a pinch of salt.

Yang warns that herbal remedies including the drugs that the Chinese official names can have unexpected risks and may not be as effective as some people claim. Also, evidence from human trials is very limited.

For similar reasons, he also notes that the mechanisms through which herbal drugs work on the body are often unclear, which may mean that they are not always safe.

A mystery herbal cure for COVID-19 on sale in Madagascar a herbal tea made from artemisia plants has also spurred worry among specialists, who say that the remedy may do more harm than good.

Matshidiso Moeti, director of WHO Africa, has also commented on this:

We [the WHO] would caution and advise countries against adopting a product that has not been taken through tests to see its efficacy.

Although people may be tempted to try anything and everything in the face of such a threat to health as SARS-CoV-2, the most important preventive step is to follow official national and international guidelines for public health, as well as individual health advice from doctors and other healthcare professionals.

For more information on the new coronavirus and how to stay safe during the pandemic, take a look at the information from the Centers for Disease Control and Prevention (CDC) and the WHO.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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5 false claims about coronavirus remedies and why they are wrong - Medical News Today

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Dublin, June 05, 2020 (GLOBE NEWSWIRE) -- The "Insoluble Dietary Fibers Market - Forecast (2020 - 2025)" report has been added to ResearchAndMarkets.com's offering.

The global insoluble dietary fibers market is estimated to be $1,965m in 2020 and projected to grow at a CAGR of 7.8% during 2020-2025 in terms of value however volume sales is poised to witness higher growth during the forecasting period.

The Asia Pacific region is estimated to be the fastest developing market for insoluble dietary fibers. This is because of the rising demand for functional food as well as the change in the lifestyles of the population. Followed by Europe and North America because of the rising demand for dietary and health supplements. The global insoluble dietary fibers market is estimated to reach 762.4KT in terms of value by 2021 growing at a CAGR of 8.8 % during the forecast period from 462KT in 2020.

Insoluble Dietary Fibers Market Outlook:

Hemi-cellulose & cellulose holds major share in the global insoluble dietary fibers market in 2020 with volume shares of 24.5% and 30.3% respectively. Chitin & Chitosan type of insoluble dietary fibers are estimated to witness rapid growth both in terms of volume & value during the forecast period. Food & Beverages is the major market for insoluble dietary fibers globally and it is estimated to continue its growth both in terms of volume & value during the forecast period.

Insoluble Dietary Fibers Market Growth drivers:

The consumer's inclination towards fiber rich products, increasing demand for functional foods and abundant availability of raw materials is driving the growth of the insoluble dietary market. Booming functional food industry outgrowth the usage of dietary fibers. Additionally the growing population of insoluble dietary fiber as a nutritional ingredient.

Insoluble Dietary Fibers Market Challenges:

Escalating competition within dietary fiber segments and among various nutritive ingredients stands as a challenge for the growth of insoluble dietary fibers. In addition reduction of anti-nutrient components in cereals brans for their use in nutritional products stands as a challenge

Insoluble Dietary Fibers Market Research Scope:

The base year of the study is 2020, with forecast done up to 2025. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. It also provides information on unit shipments. These provide the key market participants with the necessary business intelligence and help them understand the future of the Insoluble Dietary Fibers Market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats. The key areas of focus include the types of plastics in the electric vehicle market, and their specific applications in different types of vehicles.

Market Research and Market Trends of Insoluble Dietary Fibers Market

Key Topics Covered:

1. Insoluble Dietary Fibers Market- Overview1.1. Definitions and Scope

2. Insoluble Dietary Fibers Market- Executive summary2.1. Market Revenue, Market Size and Key Trends by Company2.2. Key Trends by type of Application2.3. Key Trends segmented by Geography

3. Insoluble Dietary Fibers Market-Comparative analysis3.1. Product Benchmarking - Top 10 companies3.2. Top 5 Financials Analysis3.3. Market Value split by Top 10 companies3.4. Patent Analysis - Top 10 companies3.5. Pricing Analysis

4. Insoluble Dietary Fibers Market- Market Forces4.1. Drivers4.2. Constraints4.3. Challenges4.4. Porters five force model4.4.1. Bargaining power of suppliers4.4.2. Bargaining powers of customers4.4.3. Threat of new entrants4.4.4. Rivalry among existing players4.4.5. Threat of substitutes

5. Insoluble Dietary Fibers Market-Strategic analysis5.1. Value chain analysis5.2. Opportunities analysis5.3. Product life cycle

6. Insoluble Dietary Fibers Market- By Type (Market Size -$Million / $Billion)6.1. Market Size and Market Share Analysis 6.2. Application Revenue and Trend Research6.3. Product Segment Analysis6.3.1. Hemicellulose6.3.2. Lignin6.3.3. Cellulose6.3.4. Resistant Starch6.3.5. Chitin & Chitosan6.3.6. Fiber6.3.7. Others

7. Insoluble Dietary Fibers Market- By Function (Market Size -$Million / $Billion)7.1. Anti-caking Agent7.2. Bulking/ Texturing Agent7.3. Fat Substitute7.4. Water binding Agent

8. Insoluble Dietary Fibers Market- By Source(Market Size -$Million / $Billion)8.1. Whole Grain8.1.1. Wheat8.1.2. Corn8.1.3. Rice8.1.4. Oats8.1.5. Others8.2. Vegetables8.2.1. Green leafy vegetables8.2.1.1. Spinach8.2.1.2. Carrot8.2.1.3. Cabbage8.2.1.4. Others8.3. Fruits8.3.1. Orange8.3.2. Grapefruit8.3.3. Apricots8.3.4. Mango8.3.5. Peach8.3.6. Banana8.4. Others

9. Insoluble Dietary Fibers Market- By End Use Industry (Market Size -$Million / $Billion)9.1. Market Size and Market Share Analysis 9.2. Application Revenue and Trend Research9.3. Product Segment Analysis9.3.1. Food Industry9.3.1.1. Breakfast Cereals9.3.1.2. Bakery9.3.1.3. Dairy Products9.3.1.4. Meat and Poultry food9.3.1.5. Pasta & Tortillas9.3.2. Animal Feed Industry9.3.3. Pharmaceutical9.3.4. Others

10. Insoluble Dietary Fibers Market- By Geography (Market Size -$Million / $Billion)10.1. Insoluble Dietary Fibers Market - North America Segment Research10.2. North America Market Research (Million / $Billion)10.2.1. Segment type Size and Market Size Analysis 10.2.2. Revenue and Trends10.2.3. Application Revenue and Trends by type of Application10.2.4. Company Revenue and Product Analysis10.2.5. North America Product type and Application Market Size10.2.5.1. U.S.10.2.5.2. Canada 10.2.5.3. Mexico 10.2.5.4. Rest of North America10.3. Insoluble Dietary Fibers Market- South America Segment Research10.4. South America Market Research (Market Size -$Million / $Billion)10.4.1. Segment type Size and Market Size Analysis 10.4.2. Revenue and Trends10.4.3. Application Revenue and Trends by type of Application10.4.4. Company Revenue and Product Analysis10.4.5. South America Product type and Application Market Size10.4.5.1. Brazil 10.4.5.2. Venezuela10.4.5.3. Argentina10.4.5.4. Ecuador10.4.5.5. Peru10.4.5.6. Colombia 10.4.5.7. Costa Rica10.4.5.8. Rest of South America10.5. Insoluble Dietary Fibers Market- Europe Segment Research10.6. Europe Market Research (Market Size -$Million / $Billion)10.6.1. Segment type Size and Market Size Analysis 10.6.2. Revenue and Trends10.6.3. Application Revenue and Trends by type of Application10.6.4. Company Revenue and Product Analysis10.6.5. Europe Segment Product type and Application Market Size10.6.5.1. U.K 10.6.5.2. Germany 10.6.5.3. Italy 10.6.5.4. France10.6.5.5. Netherlands10.6.5.6. Belgium10.6.5.7. Spain10.6.5.8. Denmark10.6.5.9. Rest of Europe10.7. Insoluble Dietary Fibers Market- APAC Segment Research10.8. APAC Market Research (Market Size -$Million / $Billion)10.8.1. Segment type Size and Market Size Analysis 10.8.2. Revenue and Trends10.8.3. Application Revenue and Trends by type of Application10.8.4. Company Revenue and Product Analysis10.8.5. APAC Segment - Product type and Application Market Size10.8.5.1. China 10.8.5.2. Australia10.8.5.3. Japan 10.8.5.4. South Korea10.8.5.5. India10.8.5.6. Taiwan10.8.5.7. Malaysia10.8.5.8. Hong Kong 10.8.5.9. Rest of APAC10.9. Insoluble Dietary Fibers Market- Middle East Segment and Africa Segment Research10.10. Middle East & Africa Market Research (Market Size -$Million / $Billion)10.10.1. Segment type Size and Market Size Analysis 10.10.2. Revenue and Trend Analysis10.10.3. Application Revenue and Trends by type of Application 10.10.4. Company Revenue and Product Analysis10.10.5. Middle East Segment Product type and Application Market Size10.10.5.1. Israel 10.10.5.2. Saudi Arabia10.10.5.3. UAE10.10.6. Africa Segment Analysis10.10.6.1. South Africa10.10.6.2. Rest of Middle East & Africa

11. Insoluble Dietary Fibers Market- Entropy11.1. New product launches11.2. M&A's, collaborations, JVs and partnerships

12. Insoluble Dietary Fibers Market Company Analysis12.1. Market Share, Company Revenue, Products, M&A, Developments12.2. Cargill Inc.12.3. J.Reltenmaier & Sohne Gmbh & CoKg.12.4. Roquette Freres12.5. Archer Daniels Midland12.6. Ingredient Inc.12.7. E.I.DuPont De Nemours and Company

13. Insoluble Dietary Fibers Market-Appendix13.1. Abbreviations13.2. Sources

For more information about this report visit https://www.researchandmarkets.com/r/fkdedy

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Insights on the Worldwide Insoluble Dietary Fibers Industry to 2025 - Featuring Cargill, Roquette Freres & Archer Daniels Midland Among Others -...

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The singer, 39-year-old Jessica Simpson

The singer, 39-year-old revealed her dark past in her new book, Open Book.

Jessica Simpson was seen in the late 90s and early 2000s as one of the singers youth more and more popular and although it is claimed that it was always the shadow of Britney Spears and Christina Aguilera, has had many successes in its time. Despite this, the beautiful and stereotypical artists was always the victim of comments and sexist attacks by their female partners, but this 2020 time has come to unveil its dark past and its most intimate secrets.

The already controversial autobiographical book by Jessica Simpson, entitled Open Book sets out passages from their early beginnings in the music, which ensures that the music producer Tommy Mottola, the husband of mexican singer Thalia, forcing her to lose weight 7 kilograms to be famous.

He (Mottola) wanted to firmarme. And then he said have you got to lose 7 kilos, writes Simpson, who, despite measuring 1.60 and weigh 53 kilos, had to lose weight so they could sign with his label. From there, remember the singer of 39 years, suffered many eating disorders and makes sure that he lived a hell because I felt hungry all the time. Image: Clasos

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Jessica Simpson makes sure that Tommy Mottola, the husband of Thalia, forcing her to lose weight abruptly - OI Canadian

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By Jeremy Schwartz, CFA

One question we are often asked is, "why bother with international investments?" U.S. multinational companies have revenue generated all over the world, so what if diversification is just a matter of "de-worseifying" and bringing suboptimal outcomes?

I understand this concern, considering that for a long stretch of time, the U.S. has outperformed the rest of the world. Over the past 10 years ending May 31st, the MSCI USA Index has outperformed the MSCI EAFE Index by more than 7% annualized per year.1

However, we believe there are long-run benefits of investing globally.

There are strong parallels to "growth" dominating "value" within the U.S. markets when looking at foreign markets versus the U.S.

Standard market cap-weighted international indexes have sector exposures akin to U.S. value benchmarks. There is a particular lack of technology sector exposure and overweight positioning in financials and commodity-dependent sectors.

But not all international strategies have these sector tilts.

The WisdomTree international quality dividend growth strategies have a sector balance closer to the S&P 500, particularly being overweight in Technology versus the MSCI EAFE Index and providing meaningful weights to the Health Care and Consumer sectors.

Below we show the WisdomTree International Quality Dividend Growth Fund (BATS:IQDG), which is derived from a developed world universe, as well as the WisdomTree Global ex-U.S. Quality Dividend Growth Fund (NYSEARCA:DNL), which screens from a global universe (minus the U.S.) that also includes emerging markets.

In shifting the weight away from traditional value benchmarks, they also have little exposure to sectors that are typically value heavyweights, such as Energy and Financials.

We believe screening for profitability, low leverage and earnings growth creates a valuation profile that is more attractive than broader international benchmarks.

Yes, the MSCI EAFE Index is less expensive than the S&P 500 on a price-to-earnings (P/E) ratio basis (by about five points), but the S&P 500 has a return on equity (ROE) that is 65% greater, profit margins that are 35% higher and less leverage. We believe these higher margins and profitability ratios warrant the premium multiple of the S&P 500.

By contrast, when one focuses on these profitability and growth metrics in selecting higher quality companies, the situation is completely reversed.

Developed World: The WisdomTree International Quality Dividend Growth Fund, which seeks to track, before fees and expenses, the price and yield performance of the WisdomTree International Quality Dividend Growth Index, currently has an ROE that is 41% greater than the S&P 500, profit margins 4.7% higher and a leverage ratio that is approximately one-third that of the MSCI EAFE Index and half of the S&P 500. For these better profitability and growth metrics, investors are also not paying a premium multiple to the S&P 500 but getting the market at a two-point P/E discount instead.

Global ex-U.S.: The WisdomTree Global ex-U.S. Quality Dividend Growth Fund, which seeks to track, before fees and expenses, the price and yield performance of the WisdomTree Global ex-U.S. Quality Dividend Growth Index, was able to improve ROE and margin ratios even further and is available at a lower multiple of 15x for the developed world universe.

While the characteristics of broad international benchmarks are understandably "less expensive for good reasons," we believe our basket of international quality stocks looks attractively priced versus the S&P 500 for its improvement in quality and growth characteristics.

The performance history appears quite compelling to us as well. Both recently and over the long term, the two funds have outperformed similar broad market indexes that are market cap-weighted. In most cases, they've outperformed by a few percentage points as well, signaling that there have always been opportunities in international markets, despite them being out of favor.

For standardized fund performance of the Funds in the table, please click their respective tickers: IQDG, DNL.

Likewise, the relative performance has demonstrated their appeal in both up-markets and volatile ones. In many cases, the Funds were able to add value the most when the broad indexes declined, resulting in a downside buffer or even outright positive performance.

IQDG Performance vs. MSCI EAFE

DNL Performance vs. MSCI ACWI ex-U.S. Growth Index

At WisdomTree, we believe there are just as many opportunities in international markets as there are in the United States. The differentiator, however, is accessing them in the right way, and we are confident that a quality and dividend-oriented approach might provide investors with the results they're looking for when investing overseas.

1Source is Bloomberg as of 5/31/2020.

Important Risks Related to this Article

There are risks associated with investing, including possible loss of principal. Foreign investing involves special risks, such as risk of loss from currency fluctuation or political or economic uncertainty. Funds focusing their investments on certain sectors increase their vulnerability to any single economic or regulatory development. This may result in greater share price volatility. Heightened sector exposure increases IQDG's vulnerability to any single economic, regulatory or other development impacting that sector. This may result in greater share price volatility. IQDG invests in the securities included in, or representative of, its Index regardless of their investment merit, and the Fund does not attempt to outperform its Index or take defensive positions in declining markets. Due to the investment strategy of IQDG, it may make higher capital gain distributions than other ETFs. Please read each Fund's prospectus for specific details regarding the Fund's risk profile.

Jeremy Schwartz, CFA

Executive Vice President, Global Head of Research

Jeremy Schwartz has served as our Executive Vice President, Global Head of Research since November 2018 and leads WisdomTrees investment strategy team in the construction of WisdomTrees equity indexes, quantitative active strategies and multi-asset model portfolios. Mr. Schwartz joined WisdomTree in May 2005 as a Senior Analyst, adding to his responsibilities in February 2007 as Deputy Director of Research and thereafter, from October 2008 to October 2018, as Director of Research. Prior to joining WisdomTree, he was head research assistant for Professor Jeremy Siegel and helped with the research and writing of Stocks for the Long Run and The Future for Investors. Mr. Schwartz also is co-author of the Financial Analysts Journal paper, What Happened to the Original Stocks in the S&P 500? He received his B.S. in Economics from The Wharton School of the University of Pennsylvania and hosts the Wharton Business Radio program Behind the Markets on SiriusXM 132. Mr. Schwartz is also a member of the CFA Society of Philadelphia.

Original Post

Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.

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The Potential Long-Term Benefits Of Investing Globally - Seeking Alpha

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Take a glance at India Morse's Instagram feed and you'd be forgiven for thinking she was just another fitness influencer posting workouts, healthy recipes, and the odd mirror selfie.

But look a little more closely and you'll learn that Morse, whose handle is @youleanmeup, has a mission greater than helping people get fit she's fighting for more accessibility in the industry.

A post shared by Youleanmeup (@youleanmeup)Apr 30, 2020 at 3:27am PDT

Morse was born deaf and believes that the fitness industry isn't inclusive enough.

One of her main gripes, she told Insider, is that workout classes aren't visual enough for the deaf community.

"There's always so much talking throughout classes and a lot less action!" she said.

"Usually the major barrier in the fitness industry is the fact that the classes are always based in such dark environments.

"Fitness classes tend to be very dependent on having music to go along with the vibe but in all honesty, they often forget about the importance of being visual."

Morse created her own coaching platform with subtitles and voiceovers on all videos. India Morse

Morse, who's 29 and based in London, UK, said that unless you tell an instructor you're deaf beforehand so they can use more hand gestures or write down information for you, there's rarely anything done.

Of course, over the past few months fitness classes have moved from boutique studios to Instagram Lives, but these are no better for the deaf community.

"The virtual live classes, especially on Instagram, aren't really accessible as they keep moving around whilst I'm having to try to lip-read them or they suddenly shout out that they are changing the workout at the last minute which I don't know as I cannot hear," Morse said.

"Prior to the workouts beginning, I have tried following what they are saying but due to the lack of being visual in their explanations I regularly get lost and don't know what to do, and then they suddenly say 'go' and the workout is in full swing!"

Morse said it affected her a lot at first, but then she adapted and decided she would simply have to create her own workouts. And that's what she did.

With 14,000 followers on Instagram, Morse is a micro-influencer.

However, she believes the social network should be doing more to cater for the deaf community.

"I would say it has poor accessibility, for example live workouts without any captions," Morse said. "It would be amazing if they considered this."

A post shared by Youleanmeup (@youleanmeup)Apr 8, 2020 at 11:23am PDT

It's not just Instagram though Morse laments the fact that podcasts aren't accessible to her either.

"I am really gutted that I miss out on all of the podcasts out there, a lot of people have mentioned them and how they have really helped them," she said.

"It's just such a shame that I'm not able to access such information as I would like to be well educated instead, I'm often behind with things."

In May 2020, Morse launched her online coaching app, Coaching By India: a whole platform with captions and an interpreter voicing everything Morse signs in video demonstrations.

"This means that absolutely no-one can miss out, it isn't just for the deaf community and I want to encourage anyone and everyone to get involved!" she said.

A lot of her clients are people who've faced accessibility issues within fitness.

"They are so happy to have me as their online coach now because I am able to communicate with them with no barriers," she said.

"Happy clients = happy and healthier lifestyle!"

A post shared by Youleanmeup (@youleanmeup)May 7, 2020 at 11:44am PDT

Morse feels so passionately about what she does because she loves seeing people "smiling, gaining confidence in themselves, and achieving their goals with my encouragement," she said.

And she certainly pushes her clients, saying she's "strict" during training.

"I tend to shout a lot (in a nice way, I promise!)" Morse said. "Maybe my deaf clients cannot hear me, thank goodness for that!"

Each sessions lasts 30 to 45 minutes, so they focus and work hard.

"The best thing about my clients is their determination to push themselves to show what they can do, along with my support all the way," she said.

Although she was sporty at school, it wasn't until her early 20s that Morse really got into fitness, prompted by a bad break-up and the need for a distraction.

Morse works out regularly but knows the value of rest days and recovery, she eats well but still enjoys chocolate and McDonald's burgers from time to time.

A post shared by Youleanmeup (@youleanmeup)Apr 27, 2020 at 12:50pm PDT

"I'm always telling my clients it's fine as long as they fit it into their macronutrient [carbohydrates, protein and fat] targets too," Morse said.

"I really am all for representing a balanced lifestyle and want to show people that they can enjoy food still."

So if you're craving something specific, don't deprive yourself as you'll likely just end up overindulging later, she said.

"I hold my hands up to the fact I still have some chocolate every day but do not believe in overindulging and then beating yourself up about it," Morse said.

"I am an advocate for eating what you want, just in smaller quantities."

Morse says that the smallest of changes could have the biggest differences when it comes to welcoming the deaf community into the fitness industry.

"Fitness could be made more accessible by doing such simple things, like adding captions and just being more visual," she said.

"Just imagine if you were deaf or put in your earplugs and see how you get on then you'll know how to make it more accessible!"

Instagram did not immediately respond to Insider's request for comment.

Read more:

A food influencer and personal trainer explains how she fits indulgent treats into her diet without gaining weight

A plus-sized woman criticized slimmer influencers for 'taking up too much space' in the body positivity sphere, and it sparked a huge debate

2 fitness influencers attempted some of the couple workouts trending on social media to show how 'ridiculous' they are

See the rest here:
Meet the deaf fitness instructor calling for more accessibility in gyms and on social media - Insider - INSIDER

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HARRISONBURG, Va. (WHSV) -- Valley Fitness owner Val Holmes was elated to reopen her gym in Harrisonburg on Friday.

"I don't remember being this excited in a very very long time," Holmes said. "It's better than Christmas, it's better than my 21st birthday if you can believe that."

Valley Fitness has added special safety precautions, adding sanitizing stations in every room, personal towels and a waiver requiring people working out to say they have not been sick. They've also distanced equipment and workout spaces.

"We put out the equipment and we put the equipment back," Holmes said. "In other words the members don't go get their own equipment. Unless they're done with it, they leave it so we can sanitize it."

Valley Fitness opened at 30 percent capacity. Holmes estimated they'd have somewhere from 200 to 300 people throughout Friday working out.

Holmes is looking forward to things going back to normal.

"I want to be able to stay open," Holmes told WHSV. "So I want to make sure we do this thing right, we're following the regulations, we're keeping the 10 foot distancing rule so that there's not a huge spike and we don't go backwards, because my goal is to go forward."

Read more from the original source:
Valley Fitness in Harrisonburg elated to re-open - WHSV

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24 Hour Fitness CEO Tony Ueber (LinkedIn, Getty)

24 Hour Fitness is in talks with entities to find a stalking horse bidder ahead of a court-supervised bankruptcy.

The mid-tier fitness chain, which operates more than 430 gyms, is seeking the stalking horse bidder before it files for bankruptcy, Bloomberg reported. The possible Chapter 11 filing would cut the companys debt and put lenders in control. Investment bankers at Lazard and attorneys at Weil, Gotshal & Manges are advising the gym on the process.

24 Hour Fitness is productively engaged with its creditors to explore strategic options and ensure the company is well positioned to serve its members nationwide for the long-term, a spokesperson for the gym operator wrote to Bloomberg.

Gyms were hit hard by the pandemic New York Sports Club is also considering filing for bankruptcy, and a market research firm estimated that the fitness industry could shrink from an $85 billion industry to a $45 billion industry this year.

But 24 Hour Fitness troubles predate the widespread stay-at-home orders and social distancing. Last year, it reported a 2 percent decline in revenue in its unaudited fourth-quarter earnings report, and membership dropped from 3.5 million to 3.4 million from the second to third quarter last year.

The company was also saddled with $1.3 billion after a leveraged buyout in 2014 by AEA Investors and a Canadian pension fund. Talks to restructure that debt load failed in March, just as the pandemic set in. [Bloomberg] Georgia Kromrei

Excerpt from:
24 Hour Fitness in talks with bidders ahead of bankruptcy - The Real Deal

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