Thursday, May 08, 2014

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 MOREDan Fabricant's FDA Insights | Nutritional Outlook

Wednesday, November 06, 2013

Menopause: On Female Power and Healthy Options (Part 2 of 2)

By James J. Gormley
Courtesy of Natural Products INSIDER Supplement Perspectives

Click here to read Part 1.

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.

Wednesday, October 23, 2013

Menopause: On Female Power and Healthy Options (Part 1 of 2)

By James J. Gormley
Courtesy of Natural Products INSIDER Supplement Perspectives

[Courtesy of 'marsmettn tallahassee'
via Creative Common
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.

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

Click here to read Part 2.

Tuesday, August 27, 2013

Newsflash: Dietary Supplements Are Safe and Beneficial: Prescription Drugs Are Not!

By James J. Gormley

On August 23rd, Newsday, a New York City newspaper ranked by Dr. Tim Groseclose as one of the top 61 most “liberal” local newspapers in the U.S. ran an article amazingly entitled, “FDA Official: 70% of Supplement Companies Violate Agency Rules.”

By “liberal” Groseclose did not mean the classical liberalism of a Thomas Jefferson or an Abraham Lincoln but the “big government,” nanny-state modern liberalism ushered in by Woodrow Wilson and expanded upon after 1921.

So perhaps we should not be completely surprised that any liberal paper would slant its coverage to support the unaccountable bureaucratic leviathan than the FDA is today ─ but, sadly, this does not serve the paper’s roughly 378,000 daily readers, readers who are, in large part, also consumers of dietary supplements ─ or at least they were before the above-cited “the sky is falling” article.

Dietary Supplements: The Real Story
Good Manufacturing Practices (GMPs) for dietary supplements are not new. The federal Current Good Manufacturing Practices for dietary supplements (21 CFR Part 111) were issued six years ago, and the Natural Products Association (NPA) rolled out its own voluntary GMP-certification program in 1999.

Contrary to the horror show of allegedly widespread incompetence, contamination and criminal negligence portrayed by the article, dietary supplements (a class of food products) are even more regulated than is food. According to whom, you ask?

How about the country’s most respected expert on food and drug law, attorney Peter Barton Hutt, who served as Chief Counsel for the FDA from 1971 to 1975, has taught food and drug law at Harvard for over 20 years, is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 3rd edition 2007), and has published more than 175 book chapters and articles on food and drug law and also on health policy?

“The [Food Drug and Cosmetic Act], as amended by DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, provides somewhat greater FDA regulatory authority over dietary supplements than over conventional food,” noted Hutt in a white paper commissioned by the Council for Responsible Nutrition (CRN) entitled FDA Statutory Authority to Regulate the Safety of Dietary Supplements (2nd edition, 2011).

Safety: The Facts
According to the Newsday article, approximately 6,300 adverse event reports were submitted for dietary supplements from 2008 to 2012, a 4-year period. 

Not even considering the fact that most of these reports were likely inaccurately linked to supplements when other factors were the more probable causes, in the same period Pharmaceutical Commerce reports that were approximately 3,260,000 adverse events reported for pharmaceutical drugs!

I don’t recall seeing this stark comparison in the newspaper article.

The FDA official quoted in the story, Daniel Fabricant, Ph.D., was formerly the science head for the NPA, and was a staunch defender of natural products until he became its chief critic at the FDA.

On August 26th, John Spilateri Shaw, the CEO of Dr. Fabricant’s alma mater, the NPA, noted in an open letter to Newsday that “industry members strongly support providing additional resources for the FDA to keep illegal products disguised as legitimate supplements off the market.”

The vast majority of “supplements are beneficial, and millions of Americans depend on them each day,” Shaw added in his letter. “Your readers should continue to use these products that safely and positively influence their lives on a daily basis.”

Prescription and OTC Drugs: Safety? Not So Much
And what about the FDA takeover of three drug plants in 2011 following “shocking conditions” at the plants where one of the most popular line of over-the-counter (OTC) pain relievers (rhymes with “i-lenol”) were manufactured. "This inspection report is pretty close to being the worst I've seen,” according to David Lebo, a professor of pharmaceutical manufacturing at Temple University in Philadelphia, in an interview for CNNMoney.

The inspections reportedly uncovered safety and quality violations in every system, control and process, from bacterial contamination, to filthy manufacturing and storage conditions, to super-potent levels of pain relievers in batches of the infant pain-relief formula.

Didn’t see much media coverage of this, did you? I only noticed an obvious absence of the products from store shelves, and that was my first tip-off.

Hutt added: “DSHEA provides greater FDA scrutiny of new dietary ingredients than exists for new conventional food ingredients and adds new safety enforcement authority for all dietary supplements that extends beyond the FDA authority applicable to conventional food.”

Adulterated Supplements Are Illegal Drugs, Not Supplements
As to cases of deliberate adulteration of dietary supplements, if the ingredients were anabolic steroids, the product in question would then be an illegal drug ─ not a supplement ─ and it is subject to action by the U.S. Drug Enforcement Administration (DEA). I have been calling for the DEA to step up to the plate since 2010.

The same with deliberate contamination with weight-loss, sleep aid, or sexual health drugs, the rare number of cases of this type of adulteration also renders this type of hybrid product an illegal drug; it is no longer a dietary supplement product or issue.

As to even more rare cases of legitimate manufacturers who unwittingly receive and use shoddy, contaminated or adulterated raw materials due to falsified documentation and certifications, it is the manufacturer’s responsibility to ensure the purity and safety of the ingredients it uses, and there are multiple mechanisms in place to quarantine, test and verify ingredients before they are included in finished dietary supplement products.

Peter Barton Hutt's Takeaway on Supplement (Hyper) Regulation
“DSHEA adds three additional procedural safeguards for dietary supplement court actions to assure that FDA will act fairly and equitably in its enforcement of safety requirements, but does not substantially change the requirements applicable to court actions involving conventional food,” noted Hutt.

According to him, “The Dietary Supplement and Nonprescription Drug Consumer Protection Act expands FDA’s regulatory authority over dietary supplements by adding postmarket reporting and recordkeeping requirements that are more stringent than those that apply to conventional food.”

“Thus, in many ways, the current food safety provisions of the [Food Drug and Cosmetic Act] provide FDA with greater substantive authority over dietary supplements than they provide for conventional food, and the modest procedural changes in the court enforcement requirements have had no impact thus far and are unlikely to have a significant impact in the future,” Hutt concluded.

To counter the article’s misleading timeline with one that more accurately reflects the safety and consumer protections surrounding dietary supplements, I offer, by way of conclusion,  this one adapted from Peter Hutt's white paper:

  • 1994: Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary ingredients.
  • 2002: Congress enacted the Public Health Security and Bioterrorism Preparedness and Response to provide additional authority to assure the safety of the food supply. In 2006, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act to require mandatory adverse event reporting systems for dietary supplements.
  • 2007: Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prohibit the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
  • 2011: Congress enacted the FDA Food Safety Modernization Act (FSMA) to improve FDA’s capacity to prevent, detect, and respond to food safety problems.

Wednesday, July 24, 2013

Congratulations Better Nutrition Magazine!

She's looking pret-ty spry for 75!

And by "she" I am referring to my editorial alma mater, Better Nutrition magazine, where I proudly served as editor in chief from 1995 to 2002, which is celebrating its 75th anniversary beginning with the August 2013 issue.

Better Nutrition has always stayed true to its mission and has constantly worked very hard to never let down its readers. It has a unique and trustworthy way of getting into people’s hands, too, via consumers’ favorite health-food stores.

James Gormley's "Earth Watch" column in 1995
The magazine has never been afraid to be out first on issues of great importance to its readers, whether breaking an environmental health story about the dangers of the Yucca Mountain nuclear waste repository (‘Physicists warn: nuclear waste-site dangers exist,’ September 1995), or a commentary on nutritional genocide (‘Iodine deficiency in China --- a crucial lesson for the U.S.’, August 1996), or an editorial in total support of St. John’s wort when most media outlets were publishing unfounded hit pieces (‘St. John’s wort is safe,’ June 2000).

With its editorials and its articles, Better Nutrition also helped re-popularize integrative medicine in the U.S. and was on the vanguard of the successful fight (between 1997 and 1998) to force the USDA to propose new USDA Organic standards that adhered to the right principles. 

The magazine has also never shied away from publicly defending the science and safety behind dietary supplements, whether in testimony I had an opportunity to deliver at the New York City Council ephedra hearings in 2000 or when I had a chance to "take on" pharma industry attorneys on FOX-TV’s ‘Good Day New York.’

Better Nutrition was the first health and nutrition magazine to commit to a rigorous focus on science in all of its reporting, an approach that was later emulated by other magazines. In addition, the magazine has been part of a movement that changed the nation’s mind-set from ‘5-a-day’ and mainstream ‘healthcare’ to optimal nutrition and integrative health.

The magazine has also never been afraid of getting personal, either, whether the topics were fear, the inspiration of Patch Adams, happiness, hope or thankfulness. In fact, readers have consistently shown their appreciation for Better Nutrition articles that inspired them, encouraged them or gave them hope.

James Gormley's "Editor's Desk", 1999
In January 2000, Better Nutrition printed a letter from Ronee Groff, president of the Learning Disabilities Association (LDA) of New Jersey, who wrote in about my December 1999 editorial, ‘Pass the squash, hold the fear: Meditations on racoons and a fear-free holiday season.’ She pointed out in her letter how fear, anxiety, worry and apprehension are a great part of the lives of people who are struggling with learning disorders. She wrote: ‘We believe it [the commentary] to be a wonderful piece, and we would love to communicate your words to those we believe would enjoy, and receive some strength from, the message.’

In July 2001, a reader from Mission Hills, Kansas, send in a card about the February 2001 commentary, which was entitled, ‘Never stop dreaming.’ His card, which I have kept on my own bulletin board for the last 12 years, reads: ‘I want to congratulate you on a most wonderful editorial, ‘Never stop dreaming.’ It is kept at my desk as a reminder to stop and look up. Thank you for putting a simple thought into words.’ ”
James Gormley's "Editor's Desk," 2001

Better Nutrition gave me the chance to learn quite a lot about nutrition: where we are, where we should be, and what can help get us there nutritionally. I’ve had such amazing opportunities, too, to learn and grow, including a press trip to China in 2001, a life-changing experince that I will never forget.

I have met so many caring and committed health-food retailers over the years, people who are truly on the front lines of health freedom. 

It’s given me the chance to learn about the regulations which support our right to high-quality, high-potency and innovative dietary supplements and about the political and economic forces which are taking aim at those rights, one of the reasons I decided to write Health at Gunpoint.

I am thankful to editor-in-chief of Better Nutrition today, Nicole Brechka, who gave a shout-out to me in the anniversary issue's editorial and to Vera Tweed in her history of the natural products industry this same issue.
Vera Tweed, Better NutritionAugust 2013

From the bottom of my heart, I wish Better Nutrition another 75 groundbreaking, conscious-raising years of commitment and service to American consumers and the health-food stores where they shop!

Sunday, July 21, 2013

New York City: A Nanny State of Mind?

By James J. Gormley

If New York City’s Mayor Bloomberg has his way, many more people will be passing out in 100-plus-degree stairwells, since his latest initiative promotes taking the stairs over riding elevators in New York City buildings.

Mind you, while taking the stairs would theoretically be much better for cardiovascular health if air-conditioned or well-ventilated, well-lit, and safe, the problem is that, in New York City at least, many of them are not.

In fact, at the July 17th press conference announcing this new initiative, New York City’s own health commissioner, Thomas Farley, admitted: “In too many buildings, the stairs are hard to find, kept locked, armed with alarms, or dark and windowless–making people afraid to use them.”

Aside from this, with the average high-rise height of 12-to-40 floors and the average apartment-building height of six stories---and considering that these dark, un-ventilated passageways can reach temperatures well over 100 degrees in the summer---it doesn’t help things when we consider that they are also dangerous.

As Donnel Baird noted in a July edition of the New York Times, “If cops are on the street, crime moves into the stairwells.”

Now while Bloomberg in not forcing people to take the stairs yet, just give him time.

Look at his recent herculean efforts to impose a ban on sugary drinks over 16 ounces (which doesn’t apply to some convenience stores or all supermarkets, and people can just buy extra drinks anyway).

On the website, Above the Law (, back on March 11, 2013, Elie Mystal wrote: “In case you haven’t been following along with developments inside Mike Bloomberg’s […] nanny state, last year our elected tyrant outlawed the sale of soda in sizes over 16 ounces at movie theaters and other public places. The mayor felt that nobody needed more than 16 ounces of soda in one sitting, notwithstanding the fact that nobody asked him what my mother thinks.”

Fortunately New York Supreme Court Judge Milton Tingling overturned the ban in March, stating  that “[The city] is enjoined and permanently restrained from implementing or enforcing the new regulations.” He added: “[The regulations are] fraught with arbitrary and capricious consequences. The simple reading of the rule leads to the earlier acknowledged uneven enforcement even within a particular city block, much less the city as a whole. The loopholes in this rule effectively defeat the stated purpose of the rule.”

In other words, even this were not an outrageous violation of freedom of choice and consumer rights, this law would still be a complete joke.

He specifically wrote that “to accept [Mayor Bloomberg’s] interpretation of the authority granted to the Board by the New York City Charter would leave its authority to define, create, mandate and enforce limited only by its own imagination.”

The judge went on to note that the Portion Cap Rule, if upheld, “would create an administrative Leviathan and violate the separation of powers doctrine. The Rule would not only violate the separation of powers doctrine, it would eviscerate it. Such evisceration has the potential to be more troubling than sugar sweetened beverages.”

As Mystal correctly opines, “I’ve been living under Bloomberg for so long I forgot that ‘so let it be written, so let it be done’ is not a sufficient state interest for the curtailing of individual liberties.”

As Mystal adds, you cannot legislate good health or portion control, and I agree with him and others that it is the height of arrogance to presume to do so.

That is not stopping Bloomberg spending millions of our-tax-dollar-paid NYC Corporation Counsel attorneys from pursuing this mad quest to the NY State appeals court.

In a June 6th, 2013 Associated Press article published on the Huffington Post, David B. Caruso wrote: “Justice David Friedman said the city appeared to be asking for unprecedented authority to regulate all sorts of portion sizes, including ‘the number of doughnuts a person could eat, the number of scoops of ice cream’ and number of servings of fried chicken.”

Unlikely as it is for me to agree with the American Beverage Association, I do in this case. According to Caruso’s article, Richard Bress, an attorney for the association, “challenged the regulation acknowledged that too much sugar can be unhealthy, but he told the court the regulation was ‘a breathtaking example of agency overreach.’ "

Bress correctly told Caruso that the city’s proposal appeared to be based more on politics than science. He pointed out, for example, that no limits would be set for calorie-gargantuan milk shakes.

Meanwhile, the appeals court has not yet set a date for its decision.

Gormley Take-Away: Whether it is the FDA saying people shouldn’t have access to raw milk (because they don’t like it, apparently), or California making almost every product or material in the state labeled with a nonsensical Prop 65 warning that “this might cause cancer,” or whether it is bureaucrats like Michael Bloomberg wagging his finger at us and telling us he will decide what’s best for us and any semblance of separation of powers or consumer rights be damned, common sense cannot be regulated and consumer choice---and citizens’ rights---must be protected at all cost. What if early American decided it didn’t like religious freedom and preferred living under the domination of oppressive rule from afar? I probably wouldn’t have the freedom to question intolerably bad policies and laws and regulations like these, and you wouldn’t have the freedom to read this blog and any other articles or books questioning them either. My suggestion: use your power at the voting booth to kick out those who would create or perpetuate Nanny State, Big Government regimes and elect those who will fight for liberty, justice and health-freedom.

Friday, May 17, 2013

Beware the Devil’s Seed(s)

Guest post by Kathleen Barnes

As I prepare to put in my garden this year, I feel a little like some whacko-zombie apocalypse fanatic. I am on a fervent mission to find non-GMO seeds and plants.

It’s not as easy as you might think since Monsanto, the father of Frankenfoods and RoundUp (what a pair!) has not only managed to protect itself against lawsuits from consumers whose health is damaged by its GMO products, it has also managed to buy up most of the seed companies and insert genetically modified organisms (GMOs) into their products.

The day is not far off when it will be impossible to buy seeds that have not been modified.

Until very recently, Monsanto had targeted corn, canola, soy and cotton, but now its gobbled up the market for the seeds you and I plant in our backyard gardens. Monsanto now owns 90 to 95 of all seed companies in the U.S. While Monsanto says it has no intention of making all seeds GMO, I can only say: If you believe that, I’ve got a bridge I’d like to sell you.

Let’s back up a few weeks to March 29 when President Obama signed into law, which has been dubbed the Monsanto Protection Act. The bill allows Monsanto to promote and plant genetically modified organisms (GMOs) and genetically engineered (GE) seeds and precludes the courts for litigating any cases contending the products are unsafe.

This unprecedented legal protection also gives Monsanto a green light to continue producing and expanding its market for GMO crops and seeds.

The danger now is that according to US laws, Monsanto always wins, even if its experimental crops are proven to be hazardous to human health and even if they cause a runaway crop plague. Now, the American government has given away the judicial power to prohibit the planting and harvesting GMO crops in almost any case.

Zombie apocalypse, indeed!

GMO foods have been scientifically linked to obesity, diabetes, immune system alterations and impaired ability to digest protein. malfunction. The Bt-toxin introduced by Monsanto in the 1990s to kill insects has now been found in the blood of 67 percent of all women, 93 percent of all pregnant women and 80 percent of umbilical cord blood in their babies.

That’s just the tip of the iceberg. At least we, as consumers, have the right to know what we’re eating. Well-financed corporate interests helped defeat the GMO labeling amendment in California. Washington state has a labeling initiative pending. More than 60 countries now requires GMO labeling, but not the U.S. This is everyone’s fight, so I encourage you to get involved.

Back home, I’m seeking out heirloom seeds and plants for my garden. I found a good list at Garden of Eatin’that not only give us a very short list of seed companies that have signed a non-GMO statement for their products and a much longer list of those that are either owned by Monsanto or have at least some GMO seeds.

Today’s revolution is with our pocketbooks. Don’t buy products from companies that have bought into the Monsanto lie.

This is a complex issue that I’ll be visiting and re-visiting frequently in the future. Stay tuned. Your health and mine and the health of the planet for the next seven generations depends on it.

All content is written by Kathleen Barnes and may be used freely if unedited and attributed.
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