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CFH Submits Its NDI Comments to the FDA

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October 6, 2011

Division of Dockets Management
(HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

Dear Commissioner Hamburg:

Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit and letter of DSHEA.

BACKGROUND

According to a July 7, 2011 report from your Agency, Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

With this as a backdrop, we are certain that your Agency is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone – calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) – could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on – it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

THIS GUIDANCE DOCUMENT

Therefore, it is mystifying to us, and to many others, why your Agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this Draft Guidance.

It is likewise baffling as to why your Agency would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” and “what is a new dietary ingredient,” for example, as bases for what is obvious is your new and intended supplement and ingredient review and enforcement position.

Your Agency is attempting to drastically change the law by saying that finished product manufacturers must submit an NDI for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

Your Agency is in disregard of the law, Section 413 [21 USC §350b] of DSHEA, which says an NDI submission is not required if “there is a history of use or other evidence of safety” supporting its inclusion, use and marketing prior to 1994. Instead, your Agency is proposing that NDI submissions be product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.

For your Agency to assert that newer technologies and improved processing and extraction methods would render ingredients as NDIs since these methods were not known prior to 1994 is akin to saying that meat-packing plants should observe the filthy and unhygienic practices that led to today’s modern food-safety system because these antiquated methods were approved then and these new processes are different.

Review and enforcement based on the re-interpretation of DSHEA expressed in the guidance would be expected to cause major disruption in the dietary supplement market, forcing a significant number of products off the market, resulting, according to estimates by a leading economist cited by another commenter, in revenue losses of over $1 billion dollars and causing the unemployment of over 100,000 Americans.

In the area of innovation, the direct result of policies behind this guidance would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from your Agency.

The American people would be harmed by the market and access implications within this document.

The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994. The harm would come from reduced consumer health in America as innovative, high-quality dietary supplements are removed from shelves or never see the light of day.

Your Agency’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law on the basis of this alone.

CONCLUSION

Neither American consumers nor the dietary supplement industry are going to stand for this unconscionable attempt by your Agency to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

We call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Sincerely,

James S. Turner, Esq.
Chair
Citizens for Health
jim@swankin-turner.com

James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health
jamesgormley01@gmail.com

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

By James J. Gormley

In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities.

In the meantime, Attorney P. Scott Polisky and Susan Brienza — on behalf of Jarrow Formulas, many members of the natural products industry and consumers who value innovation in their dietary supplements — are asking the FDA to at least extend the comment period for this guidance until July 5th, 2012.

Short of an immediate withdrawal of the guidance, Citizens for Health agrees with Attorney P. Scott Polisky and also with Hyman, Phelps and McNamara, which, in its July 26, 2011 request letter, said that “a one-year comment period is further justified given that there is no apparent and certainly no urgent public health need for a shorter period.”

Indeed, the draft guidance itself ignores the stellar record of supplement safety (vis-à-vis drugs and other FDA-regulated products).

As shown in FDA’s response to a 2006 Freedom of Information Act Request (FOIA) by JFI, in stark contrast to the more than 400,000 annual Adverse Event Reports (AERs) for drugs, there were only 129 non-Ephedra serious AERs for supplements in over 12 years — and six deaths that the FDA, in its 2006 response, found to be “biologically plausible” but not caused by the supplements.

Clearly, as many have noted, dietary supplements are safer than tap water, table salt, aspirin and even food, and it is unlikely that the newly proposed guidelines will make them any safer. Finally, when needed, the FDA has numerous regulatory and enforcement mechanisms (supplement GMPs, import alerts, Physicians Advisories, inspections, mandatory MedWatch reports for serious AERs, etc.) with which to monitor and ensure supplement safety.

Let’s ask the FDA to withdraw the guidance and to assure American consumers that it will not be heading down the road of trying to re-classify hundreds, if not thousands, of safe, historically used ingredients as “new dietary ingredients,” as this could serve as a fatal blow to the dietary supplement industry, especially those companies which feature innovative processes and formulations!

In the meantime, we can buy time by asking them to extend the comment period to July 2012.

Preventing The Swine Flu: A Comprehensive Approach

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Sneezing, coughing, fever, aches and pains…

Worried about flu symptoms like these? As winter approaches, most of us are.

But this year, the flu seems even more alarming, thanks to increased health concerns about the H1N1 influenza strain, also known as the swine flu. Even though this strain doesn’t appear to be particularly threatening, it has the potential to mutate into a more dangerous form.

The main question my patients have been asking is whether they should get vaccinated against H1N1 or against the regular flu.

This is not a simple yes or no answer. The guiding principle of functional medicine is personalized care, not the one-size-fits-all belief that everyone should have the same treatment. This applies equally to vaccines. There is risk and benefit to every medical treatment or procedure.

That is why in today’s blog I want to review what you need to consider if you are thinking about vaccination, discuss some of the risks involved, and provide you with a comprehensive 7-step plan for preventing swine flu and staying healthy all winter long.

Should You Get Vaccinated?

The choice to get vaccinated is an individual one. Selective vaccination may be helpful for some groups of people–but not everyone. Here are the facts as I see them:

The current strain of H1N1 is a generally mild strain of the flu. It sounds scarier, but, so far, fewer people have actually died from it than from the traditional flu. It may mutate but it hasn’t yet. Pushing widespread vaccination on low-risk populations exposes them to unnecessary risks.

If the H1N1 mutates, the current vaccine may not be effective against it.

The studies on the H1N1 vaccine have been limited in the rush to market.

The 1976 swine flu vaccine was linked to a serious neurological disease called Guillain-Barré syndrome, which causes severe (but usually temporary) paralysis.

The government has agreed to protect vaccine manufacturers from any lawsuits due to side effects of the vaccine, otherwise pharmaceutical companies would not make it.

Arnica Montana – Natural Treatment for Inflammation and Trauma

Arnica

original link: www.healthnews.com
By Melanie Grimes

Arnica montana is one of the most valuable homeopathic remedies. Also known as Leopard’s bane, this member of the Compositae—or Sunflower —family is used as a specific to reduce bruising and swelling, particularly after physical traumas such as falls or blows. It can be applied in a cream, gel, salve, or tincture, or taken internally.

Used by Native American and Europeans for centuries, Arnica was first described in the sixteenth century by the naturalist Tabernae Montanus, for whom it is named. The plant grows in the mountains in Europe and Siberia, where the grazing goats and oxen eat it. The yellow flowers, which are the medicinal part of the plant, are two to three inches in diameter and look similar to a daisy, hence its name Mountain Daisy. Because Arnica requires specific soil conditions, it has proved difficult to cultivate and the natural supply has become endangered.

Arnica is a wonder drug for treating trauma. It can be used to aid injuries from accidents and hemorrhages, both internal and external. Arnica can be given to treat the acute and chronic effects of injuries, but its main area of effect is for shock and trauma. It offers quick relief of concussions and contusions, aiding in the reabsorption of blood from injured tissues.

Inflammation is a reaction caused by damaged cells. It produces chemicals that cause tissue to swell and dilate. This reaction allows more blood to reach the effected area, to bring nutrients and oxygen to speed healing. This is a healthy reaction, but in times of great trauma, the increase in pressure caused by the swelling can be damaging in itself, for example in head injuries. And when the inflammatory process is continual, as in chronic disease, the swelling begins to deteriorate the tissue because of the continued overheating caused by the inflammation.

The Two Sides of Oregano

By Brenda Hyde and Lucinda Jenkins via www.fabulousfoods.com

Like most herbs, there are two sides to oregano: the culinary and the medicinal. For centuries people have used plants and herbs of all sorts for their apparent health giving qualities. How convenient that something so healthy can also add so much flavor to our daily diets.

To explore the two sides of oregano, we’ve enlisted the help of Brenda Hyde, editor of SeedsOfKnowledge.com, a website dedicated to creating and sharing family memories, and Lucinda Jenkins, editor of GlenbrookFarm.com, a comprehensive herbal website.

We’ve filled this article out with some recipes from right here at FabulousFoods.com, so you can experiment with the distinctive flavor of oregano yourself.  Find them in the related recipes section below.

The Culinary Side of Oregano
By Brenda Hyde

Oregano is an herb everyone is familiar with in some form or another. It’s an easy to grow perennial with some controversy surrounding it.

I was told long ago that true oregano has white flowers, but many times we end up with a plant that has pinkish flowers. This is actually wild marjoram. I have two large oregano plants that are probably not true oregano but sure do work well in all recipes, vinegars and the flowers are wonderful dried and used on wreaths. To be sure of what you are getting talk to someone at your garden center that understands the difference.

Oregano can be used fresh with sautéed zucchini and onions, or is a welcome addition along with cilantro to black beans.

For a simple elegant appetizer, carefully grill thick slices of provolone cheese that have been sprinkled with oregano. When the cheese is warmed and starts to melt spread on crusty fresh bread with a butter knife.

Add oregano to your fresh salsa recipes, or any Mexican dishes as well as Italian recipes.

The leaves can be dried on the stem and crumbled into jars, or frozen in individual bags, then used as fresh.

One oregano plant that is put in full sun, fairly dry soil and harvested frequently will supply all that you need. It does grow quickly and spread, but that will allow you to pot up some oregano for your windowsill and for your friends!

The Medicinal Side of Oregano
By Lucinda Jenkins

Oregano: origanum vulgare

Heard the spicy news about oregano? There is a lot of research going on right now with this common kitchen cupboard herb. It seems to be able to land a knock punch to free radicals those awful compounds in our body that cause us to age and get sick.

In a recent study sited by James Duke in his book the Green Pharmacy, Oregano a member of the mint family out ranked over 100 mint family herbs in delivering rosmarinic acid.

Action and uses:
Rosmarinic acid is a compound in oregano that is

  • antibacterial: will kill bacteria
  • anti-imflammatory: will ease swelling
  • antioxidant: means anti-aging
  • anti-viral: it will kill a virus

So not only is oregano tea good for helping to heal from a cold ,it is helpful with arthritis.

I read a comment on the internet that Oregano essential oil is strong enough to treat sewage, meaning it could kills all the nasty bacteria in sewage. I can’t back that up but thought it was an “interesting” claim.

Oregano is currently being studied by the Delaware State Univerisity with federally funded dollars, which means there is something to the powerful claims made by Scientist W H Martindale in 1910, documented that the essential oil of oregano is the most powerful plant-derived antiseptic known. He showed it was 26 times more active as an antiseptic than phenol (a powerful disinfectant).