The Spring issue of Nutraceuticals Now is now available.

Excerpts of featured articles are available on this website:

Weight management… a boosting segment
Beverages with Added Value
How to get rid of bad fats
Cocoa flavanols… show positive impact on brain

The Concept of the NREA: Nutraceutical Research and Education Act

We obtained two FDA approvals under the Orphan Drug Act. The purpose of the successful Orphan Drug Act is to promote economic incentives to companies to develop drugs, including unpatented ones, for rare or orphan diseases by granting exclusive rights to the company to make a medical claim based on clinical studies as well as reduce development costs. Later on and much to my surprise, carnitine also became available as a dietary supplement. I then learned that the dietary supplement industry is a commodity, a low profit margin one instead, just like the pharmaceutical industry which is a proprietary, high profit one.

In order to transform a segment of the industry into the pharmaceutical clinical studies model, FIM, the Foundation for Innovation in Medicine held a series of nutraceutical conferences. I proposed the NREA or Nutraceutical Research and Education Act which was introduced in Congress in 1989 by Representative Frank Pallone but not enacted. There was virtually no support from any segment of the food and dietary supplement industries nor nutritional professionals and organisations. For certain reasons, I was surprised that the formulation- manufacturing industries did not step forward with their support.

The NREA is based on the Orphan Drug Act but deals primarily with foods and dietary supplements. If, for example, a company conducts even a single clinical study that demonstrates that vitamin E or a generic herbal remedy reduces acne, FDA will grant the exclusive right to that company to make the medical claim. This would, along with formulation and manufacturing know-how, convert a product from a commodity to a proprietary one. There are lots of ways to do this.

I coined the term “nutraceutical” as a regulatory umbrella which encompasses all types of foods, special diets and dietary supplements (including herbal remedies) in order to make it easier for Congress to both understand and act on a single nutraceutical law. All other terms such as functional foods, pharma foods, herbal foods, designer foods and others are marketing terms which are understandably necessary for product promotion.

The definition of a nutraceutical is: ‘A food or parts of foods that have a health or medical benefit including the prevention and treatment of disease.’ Though the term is now in many
dictionaries, including the prestigious Oxford English Dictionary which credits me with coining the term, this and other published definitions are not correct.

A food or dietary supplement becomes a nutraceutical only when its activity is confirmed by one or more clinical studies! About three years ago I again attempted to persuade Congress to enact the NREA. Once more, history repeated itself. There was no support.

There is, however, some good news. Largely due to FIM’s conferences and public relations efforts, many companies did conduct clinical studies but lacked a sufficient proprietary position and capital to market properly. Also, they are understandably inexperienced in clinical protocol design, and many results were not optimum.

What dealt a major blow to the clinical trials movement and to the image of dietary supplements were the negative clinical results of vitamin E’s effect on cardiovascular disease. Vitamin E was the number one accepted nutraceutical by the medical profession, academic communities, consumers and the media. These studies were conceptually faulty being designed with a pharmaceutical mentality instead of a nutraceutical one. Unfortunately, there were no objections to be heard anywhere and the negative impact continues to this day, unopposed.

Then other negative news followed. Clinical studies on dietary supplements such as vitamins and minerals taken chronically were reported to have no health or medical benefits, and were heavily covered by media. These studies were highly faulty in design but, once more, no one objected and the negative impact remains.

I’d like to emphasise that I’m not addressing the current, traditional United States dietary supplement and food markets which are doing well. From a nutraceutical point of view, however, what I have said sounds pessimistic but need not be.

At the Vitafoods Europe Conference I will discuss some strategies on how to develop proprietary, high profit margin nutraceuticals including establishing brand names. There
is reason to believe that in the United States the current traditional food and dietary supplement industries and potential nutraceutical one can co-exist and dramatically complement each other.

To view the full conference programme and register, visit http://www.vitafoods.eu.com/confpr/

What are Flavanols?

Flavanols are a type of flavonoids, a group of secondary phytonutrients with antioxidant qualities found in food such as grapes, red wine, apples and both green and black teas. High levels of cocoa flavanols are present in cocoa and products containing cocoa. Studies have suggested that flavonoids and flavanols in particular, can have many health benefits when consumed regularly. Some effects have already been shown throughout the years, but new areas of benefit are still being researched and discovered as we speak.

This article is available in full in the Spring 2012 issue of Nutraceuticals Now

Research has now confirmed that excess visceral fat accumulation around the middle of the body is a major concern not just for weight and appearance but for overall health, too. It is also believed that waist circumference is a better predictor of weight-related health risks than the commonly used measurement of body mass index (BMI). Visceral fat is so dangerous to health because it has more endocrine activity than subcutaneous fat, with greater secretions of hormone-like components that negatively impact upon insulin function as well as blood sugar and triglyceride levels, and even circulation.

With visceral fat posing such a health risk, the Japanese company Kaneka spotted an opening for a product that would have wide-reaching health benefits for millions of consumers. Thus, its search began for an ingredient that would enable manufacturers to react to the increasing challenges of excess weight and its impact on health.

This article is available in full in the Spring 2012 issue of Nutraceuticals Now

Functional foods have witnessed remarkable growth during the past few years, as consumers’ awareness of the relationship between a healthy, balanced diet and their own well-being or health status increases. Apart from the basic nutritional function of calorie intake, functional foods aim to provide physiological or even health benefits. Of the many ingredients used in functional foods today, dietary fibers have become a key ingredient for product formulators, since more and more consumers understand and embrace the concept that digestive health exerts a considerable influence on overall wellness and health. Consequently, the market for fiber-enhanced foods is expected to experience further growth.

Dietary fibers are an important component of a healthy human diet and can be divided into insoluble and soluble fibers. Generally, insoluble fibers refer to a variety of plant-derived products that are resistant to the human digestive system. They do not dissolve in water, but can absorb water, so they are a good bulking agent, speeding up transit time in the gut. Soluble fiber, on the other hand, turns into a gel-like substance as it passes through the gastrointestinal tract. Both fiber types are non-digestible, but are degraded by anaerobic bacteria in the colon. Numerous studies indicate that a diet rich in fibers of both kinds significantly reduces the risk of colorectal cancer, cardio-vascular diseases and obesity.

As a soluble dietary fiber, alpha-cyclodextrin shows high stability, low viscosity and has a positive effect on the blood cholesterol level. These properties make the ring-shaped glucose molecules increasingly interesting for functional applications in the beverage industry.

This article is available in full in the Spring 2012 issue of Nutraceuticals Now

This health concern has also spread among children and teenagers. If measuring overweight or obese children, aged 5 to 14 years, is challenging because there is not a standard definition of childhood obesity applied worldwide, the trends are still clear. According to the WHO at least 20 million children under the age of 5 years were overweight globally in 2005 and ten percent of the world’s school-aged children are estimated to have excess body fat.

This study collected insights from a total of more than 5300 weight managers to have a better understanding of consumers’ behaviours, motivations and practices in managing weight. The study also looked at product attributes important to consumers in selecting foods to support their weight management goals, and specifically, consumer understanding and awareness of protein in weight management.

This study results reinforce what scientific research data shows in terms of protein’s ability to positively impact weight loss efforts.

This article is available in full in the Spring 2012 issue of Nutraceuticals Now

The Winter 2011 issue of Nutraceuticals Now is now available.

Excerpts of featured articles are available on this website:

Kemin: Innovation in tea
NSF: Learning from the mistakes of others
Peruvian natural resources

It has been more than two decades since Dr. Stephen DeFelice, along with Steve McNamara, Esq, introduced the coined the term “nutraceuticals” that ultimately contributed to the development of a new global industry now valued at nearly $12 billion. Popular products, such as probiotics, components of soy, tomatoes, fish, tea and an array of herbal and non-herbal extracts have been the target of considerable research since those early days. This movement within the food industry, intersected with the dietary supplements industry, has prompted the development of many health claims directed to consumers burgeoning for improved health.

The prevalence of Non-Communicable Diseases (NCDs), such as obesity, cardiovascular disease, hypertension and diabetes, continues to rise. At least one of these diseases affects more than two-thirds of those living in the United States. Thus, there are numerous opportunities for the respective industries, from cultivars planted in the fields to innovated food and food component management technologies to have a positive impact on health.

Importantly, there has been considerable research in the arenas of cancer reduction, blood lipid profile improvement, antioxidant potential, anti-inflammatory applications, and bone health. These research areas, which involve multiple disciplines, target largely plant-derived components such as isoprenoids, phenolic compounds, proteins and amino acids, carbohydrates and their derivatives, fatty acids and structured lipids, various minerals, and even microbial-impacting substances like probiotics and prebiotics.

The food chemistry of substances within these areas is quite interesting. On the other hand, what is critical to this chemistry is our understanding of their metabolism (aka metabolic fate) within the traditional ADME (absorption, distribution, metabolism, excretion) assessment among humans. Most of the physiological data are derived from animal studies and cell culture models. Importantly, there is dearth of pharmacokinetics data on the majority of these compounds. For example, a few pharmacokinetic studies on resveratrol, the dominate polyphenolic in red wine, indicate maximum plasma level of this compound and its metabolites is achieved within 1-2 hours, has a half-life of about
9 hours, and is mostly eliminated within about 4 hrs via urine. Notably, only about 70% of resveratrol is absorbed.

Reaching beyond nutraceuticals, research is leaning towards pharmanutrition. Again, using resveratrol as an example for clinical implications, such as inflammation and cardiovascular disease, it takes about 60 mg daily for at least 6 weeks to reduce some forms of inflammation, and as much as 500 mg to reduce risk some factors associated with cardiovascular disease. Considering some red wines may contain as much as 4 – 6 mg of resveratrol per 4 oz (120 mL) serving, one would need to routinely consume 15 to 100 servings to achieve some of these health benefits.

The concept of nutraceuticals and functional foods has considerable merit. The research in this arena requires additional research in chemistry, classic clinical assessments, and traditional pharmacological evaluation consistent with standards outlined by the International Conference on Harmonization. For consumer benefits and clinical applications future studies must consist of well-designed clinical trials. In addition, the nutraceutical industry must provide sufficient evidence that is strong, consistent, clinically relevant, and generalizable to the population.

Roger Clemens
President, Institute of Food Technologists

In a time where consumers are looking to improve their health with products that are natural, safe and environmentally friendly, there is space for innovation, and the tea market is not an exception. The new generation of tea products must bring the benefits of teas in unique natural forms, ensuring efficacious products that adjust to the needs of its users and fulfill the growing market demand on natural and safe high quality products to the consumer’s overall health.

Antioxidants can prevent the formation of damaging oxidative radicals thus decreasing oxidative stress, one of the factors believed to be responsible for several chronic diseases and aging. Nowadays, antioxidants are perceived as healthy, with 23% and 53% of the general population feeling that they are deficient in antioxidants, and willing to add more antioxidants to their diet, respectively. Based on this growing consumer demand, the antioxidant market appears as an attractive, large and growing market.

Tea is a major contributor to the global antioxidant market, with 77% of the users consuming tea for their overall health and 70% to promote anti-aging. Thus, the tea market offers several opportunities, as tea is the most popular beverage in the world after water, and a product that mainstream consumers can easily relate to. Moreover, tea is perceived as safe and healthy, with 61% of the people believing that tea contains components that reduce the risk of disease. Generally, consumers are looking to improve their overall health with products that are natural, environmentally friendly, and exhibit a high safety profile, while also having scientific evidence of efficacy.

This article is available in full in the Winter 2011 issue of Nutraceuticals Now

Despite a struggling economy, the US nutritional products industry was estimated to have reached 117 billion dollars in 2010, a 6% growth over the previous year. With 65% of US adults, roughly 150 million people, labeling themselves as supplement users , the opportunity for nutritional product manufacturers has not gone unnoticed. In fact, the number of nutritional supplements on US store shelves has surged from 4,000 to an estimated 75,000 since the Dietary Supplement Health and Education Act, or DSHEA, was passed in 1994.

This fantastic growth and proliferation of new products has created new challenges for the industry in terms of standardizing safety and quality, not to mention the regulatory hurdles that come with a globalized supply chain. To establish quality-control standards for US nutritional products, the US Food and Drug Administration introduced Good Manufacturing Practices (GMP) regulations in 2007. GMPs require that the processes by which nutritional supplement ingredients are produced are safer and free of possible contamination. This includes all aspects of the manufacturing process, from raw material control to finished product release, as well as training of personnel, qualification and validation of testing equipment and methods, product traceability and facility maintenance.

Why does this matter to a Europe-based nutritional product manufacturer? As of last year, every organization that wishes to participate in the booming US nutritional products industry must demonstrate compliance to these GMP regulations. Although European nutritional product manufacturers are no strangers to meeting rigorous regulations, they have the unique challenge of demonstrating compliance to both EU and US regulations, which have few similarities.

The cost of noncompliance is steep and many manufacturers are still struggling to comply as evident by a 42% increase in warning letters issued by the US FDA in 2010 . Noncompliance with US GMPs can trigger a number of undesirable outcomes: public warning letters, products labeled as adulterated, seizure by authorities, injunction from manufacturing, and damage to brand and company reputation.

This article is available in full in the Winter 2011 issue of Nutraceuticals Now