The Heart of the Matter: Ingredients for Heart Health

By James J. Gormley


Heart health as a category has changed over the last 20 years. Years ago, health and nutrition magazines would tout the benefits of single vitamins, herbs or minerals: vitamins A, C and E; hawthorn, cayenne and garlic; and selenium. With the exception of hawthorn, these continue to be popular for cardiovascular health formulations.

In recent years, while other standalones that pack a punch for heart health have risen to greater prominence — coenzyme Q10, green coffee extract, fish oil, and recently magnesium — science has moved in the direction of much more sophisticated formulations, often featuring proprietary extracts or premium standalones with active ingredients produced via patented processes, a few examples of which are:

• AmealPeptide for heart health and blood pressure (milk-derived bioactive tripeptides that are extracted from milk proteins during a patented production process);   
• Blueberry flavonoids; 
• Citri-Z for heart health (proprietary blend that exclusively provides polymethoxylated flavones [PMF] and other bioflavonoids;     
• Curcumin for heart health; 
• Green coffee bean extracts for cholesterol and blood pressure;    
• Resveratrol for cholesterol;    
• Sytrinol for cholesterol (patented and proprietary formula derived from natural citrus and palm fruit extracts); and  
• Vitamin K2 (MK-7) (promotes heart health via help with arterial elasticity).

Part of the reason for this is that nutritional and botanical science has become more advanced, and part of the reason is that companies want to have unique formulations using one or more premium, patented ingredients or blends in order to differentiate their products from the rest of the ticker-boosting supplements that are out there.

That being said, promotion of heart-health products as part of a healthy lifestyle is becoming increasingly important to manufacturers and marketers, not only because that is more FDA/FTC friendly and more responsible for consumers, but because Americans are sick and tired of being told by Big Pharma to take pills to address health problems without addressing some of the most critical underlying causes of heart un-health: chronically poor food choices and sedentary ways.

Consumers are not thrilled with just taking more pills, whether they are supplements or pharmaceuticals, and they are not thrilled with the idea of having to devote many hours per week on heavy-duty exercise.

While anybody can capture a wallet, at least for a day, if marketers can encourage consumers to incorporate sensible supplementation into a by-and-large healthy diet with a reasonable amount of exercise, then these products (and their ingredients) will have a chance to truly capture hearts and minds, a concept Kevin Thomson rightly outlines in his book, Emotional Capital. Then you will have the consumer for a lifetime.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Premium Ingredients, Commodity Ingredients: No "Versus" Needed

By James J. Gormley



First off, what are “premium ingredients”? The term is so broadly used that the lines between intrinsic value and marketing speak do, at times become blurred.

Premium can mean any of these things, and more:

• A very pure or high quality source.
• An ingredient that has a “value-added” quality associated with it, such as a unique manufacturing, fermentation, purification or refining process, often protected by patents.
• Ingredient compounds protected by composition of matter patents or use patents for a given application.
• A unique delivery form, usually for enhanced absorption and bioavailability, ergo efficacy.
• A proprietary blend (although this is highly debatable as to whether proprietary makes it premium: see below.)

If you want to use or develop a premium nutritional ingredient, what considerations are involved?

Here are some bad reasons not to use or source a premium ingredient:

1. I just want to be able to charge more money and make better margins.
2. I only want to differentiate my finished product from competitors’ products.
3. I want to hide poor-quality or filler ingredients under a “proprietary blend” shield.

Here are some good reasons to use or source a premium ingredient:

1. I want to provide the most effective product I can, matching wherever possible the dosages and ingredient forms used in clinical studies.
2. I want to provide consumers with maximum value.
3. I want to utilize ingredients produced via technologies that developers have invested millions of dollars in.

As to the cost burden on consumers, in cases where there is a very high price point thanks to the use of premium ingredients, Michael Lelah, technical director for Bloomingdale, IL-based NOW Foods: says: “Yes, consumers ultimately decide, and we work hard to bridge the gap between commodity and premium ingredients for and on behalf of the consumer.”

Noting that NOW Foods, for example, tries to provide premium ingredients wherever possible, “There are times when we can’t justify the high price of a premium ingredient based on its increased benefit, and we are not prepared to pass this on to the consumer.”

As to the question of economic adulteration hiding behind the “proprietary blend” aegis, Lelah notes: “We believe in full transparency on our labels. All our nutritional ingredient amounts are declared on our labels and we in most cases declare the potency of the ingredient or key botanical marker, so the consumer knows what they are purchasing.”

I would imagine that other companies share NOW Foods’ way of approaching the question of premium versus commodity. In addition Federal cGMPs are starting to level the playing field between premium and commodity ingredients, as well.

So there you have it: when it makes sense, doesn’t create an unreasonable price point, and is utilized for the right reasons, premium ingredients can be a great choice. That being said, since the quality of U.S. commodity ingredients is rising every day, these ingredients can serve as the foundation for formulas, with premium ingredients added for specific applications.

 [Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Dan Fabricant's FDA Insights | Nutritional Outlook

In April, Daniel Fabricant, PhD, ended his three-year tenure as FDA’s Director of the Division of Dietary Supplement Programs. Fabricant has since returned to the Natural Products Association (NPA; Washington, DC), where, prior to joining FDA, he served as vice president of global government and scientific affairs. (FDA has named William Correll interim head of Dietary Supplement Programs. Correll hails from FDA’s Center for Food Safety and Applied Nutrition.)

Nutritional Outlook and industry members will be watching with interest to see how Fabricant’s inside experience at FDA with policy issues such as New Dietary Ingredients and Good Manufacturing Practices (GMPs) informs his work at NPA going forward. Upon Fabricant’s departure from the agency on April 18, 2014, FDA said: “Dr. Fabricant worked hard to strengthen the FDA dietary supplement program,” noting that, during his time there, the agency took several court enforcement actions and issued numerous warning letters to companies, including for adulteration, mislabeling, and GMP violations.

Now firmly back at NPA, this time as its CEO—succeeding John Shaw—Fabricant spoke to Nutritional Outlook’s James Gormley about a range of issues, from the future of the NPA, to emerging champions on Capitol Hill, GMPs, and more.

READ MORE: Dan Fabricant's FDA Insights | Nutritional Outlook

Shaking Up the Joint(s)

By James J. Gormley


The oldest Baby Boomers are now turning 68; the youngest are clocking in at 50. It’s clear: the U.S. has an aging population that is being confronted by all of the annoyances and challenges associated with senescence, including those associated with our joints.

With global bone and joint health market expected to reach $9 billion by 2017, according to Global Industry Analysts, U.S. ingredient sales of the granddaddies of joint health supplementation – glucosamine sulfate and chondroitin sulfate – were approximately $235 million (according to Synutra Ingredients’ website) for 2012.

While their widespread appeal in the mid-1990s led to initial sales that were like wildfire, there were certain challenges that beset these now-mainstay ingredients, especially chondroitin.

Initially, chondroitin was criticized by some since, (a) its molecules were said to be up to 300 times larger than those which make up glucosamine and so could not be absorbed, and (b) the first research on chondroitin was mainly made up of animals that had received it intravenously.

Lately, chondroitin adulteration has become a concern, yet fortunately some industry leaders, such as Weiguo Zhang, president of Synutra Ingredients and makers of Chondro Gold™, have called for much more stringent screening for impurities and adulterants, so it is hoped that an increased industry focus using combination test methods will expose suppliers engaging in economic adulteration.

Regardless, glucosamine and chondroitin are maturing as ingredients, and that is opening up some opportunities for other ingredients to gain a foothold in the joint health market.

MSM is one such ingredient. While not a new ingredient, MSM (such as Bergstrom Nutrition’s OptiMSM®) has been earning its position as one of the core ingredients included in popular combination joint-health formulas.

Another ingredient that has been around, yet which has been gaining traction, is collagen. With most of the early denatured-vs.-undenatured battles now behind us, InterHealth’s UC-II® and BioCell Collagen® have risen to the fore.

Omega-3s is a more recent entrant into the joint-health race, bringing with it widespread trust and recognized benefits in other health areas. Newer, cutting-edge ingredients have also gained popularity in the market, including ASU (Avocado/Soybean Unsaponifiables), Meriva-SR® curcumin from Thorne Research, ApresFLEX® from Laila Nutra, and 5-LOXIN™ from PLT Health Solutions.

While the aforementioned is not an exhaustive inventory of joint health’s shining lights, what the emergence of these newer ingredients demonstrates is what the consumer demands, the consumer will eventually get. End users have been looking for joint-support ingredients that don’t take months to kick in, efficacy-wise.

They want to see benefits in days, and that’s what some of the latest and most interesting finished products in this area are focused on today: real results, fast.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Expo West 2014 Book Signings

Greetings, fellow Natural Products Industry members: 

Are you attending EXPO WEST this week?

Then I invite you to visit the Square One Publishers BOOTH #3356 on Friday or Saturday at 11:00 am to say "Hi!"

I will be signing autographs for my new book, Health at Gunpoint: The FDA’s Silent War Against Health Freedom.

WHAT: Book signings for James Gormley’s new book, Health at Gunpoint.

WHERE: Natural Products Expo West, Square One Publishers BOOTH #3356

WHEN: 
• Friday, March 7th, 11:00 am PST and Saturday, March 8th, 11:00 am PST.

You can order the book here.

I look forward to seeing many of my friends at the show!

On Menopause and Healthy Options, Part 2

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

In 2006, I asked Jacob Teitelbaum, MD, whether menopause has been politicized.  “Not so much politicized as commercialized,” said Teitelbaum.

“There is big money to be made in supplying hormones to women in menopause. Unfortunately, natural hormones were not able to be patented, so the drug companies used Premarin, which is simply pregnant horse urine. The process for making this was patentable. Because of this, almost all marketing and research was done on Premarin. This was despite holistic doctors saying for over a decade that it was insane to use pregnant horse urine in human females.”

“Now that the research has shown HRT to potentially be dangerous, even though the research suggests that the bioidentical hormones are much safer and likely less noxious in terms of side effects; the drug companies are paying for a very expensive misinformation campaign to mislead the American public,” Teitelbaum added.

“Because bioidentical hormones present a major competition to them (they are cheaper, safer, and simply what your body is used to making), they are paying to make sure that people get confused so that they keep buying the expensive prescription forms of estrogen and progesterone. It reminds me of the old days when doctors were being paid to promote smoking and also to convince mothers that anyone who breast-fed was a primitive who was damaging her child.”

Fortunately, natural support abounds.

Many studies, for example, support the use of black cohosh for relieving menopausal symptoms. In fact, previous trials have shown black cohosh to be as effective as HRT for reducing hot flashes. St. John’s wort has been found to help relieve mild-to-moderate depression. In addition to black cohosh (Cimicifuga racemosa), other ingredients and products are also on the market, including: red clover; soy; chaste tree (Vitex); hops; dong quai; sage; essential fatty acids; and good, old-fashioned diet and exercise.

In line with this, on October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

The conference covered such topics as: the safety and efficacy record of black cohosh; the benefits of ginseng, kava, kudzu, maca, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, and multi-ingredient combinations; detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and (once again) black cohosh; and the importance of reducing body fat, in addition to supplementation with chromium, carb blockers, green tea extract, and conjugated linoleic acid.

So, all in all, there’s a lot of good research out there on safe options for female consumers (and those who love them) to empower themselves with safe, effective, science-backed supplements that will support, nurture, and cherish women on their health journeys.

On Menopause and Healthy Options, Part 1

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Menopause is a life stage, just like puberty. In fact, in an interview I conducted in 1996 an editor for the American Botanical Council (ABC) put it this way:

“In puberty, a girl comes into her power as a woman. In menopause, a woman’s power deepens and strengthens. Menopause is a time for self-reflection — a time to evaluate where one has been, where one is presently, and where one wants to go. It is a time when women experience what Joseph Campbell calls their ‘function to be.’ ”

This initial time of change, referred to as peri-menopause, often kicks in several years before a woman’s last menstrual period. It lasts for one year after her last period, the point in time known as menopause. In fact, a full year without a period is needed before a woman can say she’s been “through menopause.”

The average age of menopause is 51.4, but before this, as mentioned above, usually in a woman’s 40s, changing levels of estrogen and progesterone often signal what are eventually considered symptoms of menopause. Women may have different signs or symptoms during menopause, mainly because estrogen is used by many parts of her body. That does not mean that she will have all, or even most, of them.

Moreover, signs that occur around the time of menopause may actually be a result of growing older, not changes in estrogen, such as: mood changes; hot flashes; osteoporosis; sleep problems; and heart disease.

In modern times, moderate-to-severe menopausal complaints were managed via conventional medicine with hormone replacement therapy (HRT). However, since a body of published research links the use of HRT with increased risks of breast cancer and heart disease, the search for safer alternatives has intensified.

In a 2004 review article by Taya McMillan, MPH, and Saralyn Mark, MD, in the Journal of the American Medical Women’s Association, “Forty percent of all menopausal women seek medical attention to alleviate symptoms of menopause.” They added that, “increasing evidence suggests that women are looking to complementary and alternative therapies for management and treatment of menopausal symptoms.”

“While many hormonal, physiological and digestive changes take place during menopause, perhaps the aspect most focused on by women and in medical literature is the symptom of hot flashes — for many women this symptom is one from which they simply want relief,” the ABC added.

Unfortunately not content to allow women to take charge of their own health without medicalizing their bodies, the FDA, at the behest of Big Pharma, on April 29, 1998 proposed re-classifying common conditions associated with natural states, such as hot flashes associated with menopause or premenstrual syndrome associated with the menstrual cycle, as “diseases” — a proposal which generated over 100,000 comments, most of which were in strong objection.

In Part 2, I’ll look at the aftermath and how the natural products industry can provide a safe and healthful solution.