Thursday, April 12, 2007

BE HEARD: FDA Commentary Open for Complimentary & Alternative Medicine

A Guidance Document open for public comments over at the FDA came to my attention this morning. The comment period ends April 30, 2007 and I strongly encourage my readers to take a few moments today to submit comments along with some additional follow-up.


Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, Docket No. 2006D-0480 is as detailed and vague as it gets. It seeks to "tie up loose ends" many feel exist in current regulation around approaches used in Complementary and Alternative Medicine (CAM) by establishing guidance for industry about communicating benefits of a "wide array of healthcare practices, products and therapies that are distinct from practices, products, and therapies used in 'conventional' or 'allopathic' medicine."

The critical issues to think about:

1. The guidance document, if finalized as written, will regulate virtually all herbs and supplements as drugs if they actually benefit a medical condition unless it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."

Not only that, but also...

2. The document, if finalized as written, is extremely vague as to the extent of regulatory reach. For example, the document states, as an example, that vegetable juice (yes, vegetable juice) "absent any claims that would make the juice subject to the drug definition, the juice would be a 'food' under section 201 (f) of the Act because it is used for food or drink for man."

Now earlier in the document, in an attempt to define how vegetable juice might be defined as a drug, it is stated, "This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for food in the Act and FDA regulations...If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would be subject to regulation as a drug under the Act."

The FDA defines a drug as "...(B) articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals..."

So, with that, any person (or product) that states "drink some vegetable juice to prevent [insert disease]" is making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or company) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.

Vegetable juice, a drug?

Not only that, but also...

While it may seem unthinkable, consider this, as another blog highlighted, "[i]ts very specificity makes manifest fundamental inconsistencies and absurdities in the DSHEA law. If you substitute "water" for "cranberry tablets" and "severe dehydration" for "urinary tract infection," as found on Page 12, then you've turned water into a drug according to these guidelines. Obviously, the FDA would never turn water into a drug, but the guidelines allow them the option to do so. That "flexibility" alone makes the guidelines dangerous. In reality, what the guidelines do is extend the FDAs authority to arbitrarily decide when to enforce their will."

Not only that, but also...

The most alarming thing to me is the use of language throughout the document - the FDA sets the stage that anyone who is not a licensed healthcare professional (physician, nurse, DO, etc.) will be subject to prosecution for practicing medicine without a license because the terms used, "medicine" rather than modality, "treatment" rather than therapy. This is because of already established regulations and laws in all 50 states as to whom may "treat" medical conditions; these new regulations will specifically limit whom is able to communicate options to consumers to those holding a professional license. Any practitioner - homeopathic, naturopathic, reflexologist, Chinese or Ayruvedc practitioners, nutritionists, etc. - will all be at risk for practicing medicine without a license if they even suggest something like vegetable juice may prevent, treat or mitigate the symptoms of a disease.

Which brings us back to the vague nature of the document...the specific language - everything termed as medicine and treatment - leaves the very real potential that any and all substances - vitamins, minerals, herbs, co-factors, probiotics, etc - could be classed drugs, new drugs, or medical devices if they are being recommended to prevent, treat, mitigate or cure disease states (remember water cures dehydration).

While the media is silent on this, the FDA quietly awaits comments that few know are open.

Well, now you know and now you can let the FDA know what you think - because if we do not comment we'll have no one to blame when we lose access to the vast options available to us right now.

Here is what you can do to let your voice be heard:

1. Submit comments online. Be sure you include the Docket No 2006D-0480 with your comments.

2. You can also send comments via snail mail to:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

3. You can call and chat up the following people and let them know what you think:

Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739

4. In addition to the above comment submissions, write or call your representatives and senators! You can find the contact information for your representatives in the House and Senate here.


  1. Mike Torchia4:15 PM

    Michael Torchia, Health Advocate, Submits Bill Proposal to Gov. Schwarzenegger to Help Campaign to Combat Epidemic of Obesity

    Michael Torchia, Health and Wellness Expert, who founded "Children's Fitness Academy" to help fight the epidemic of childhood obesity, created a bill to reform and create stricter guidelines for the manufacture of packaged foods. He is requesting stricter Guidelines for manufacturers, distributors and marketers of foods that contain toxic ingredients so that they will be held accountable for their products.

    Los Angeles, CA. April 24, 2007 -- Michael Torchia, Health and Wellness Expert, founder of Children's Fitness Academy, is requesting help from Governor Schwarzenegger by asking him to submit a bill through his office to help regulate the activities of the giant food manufacturers.

    Torchia feels Governor Schwarzenegger, as a famous and immediately recognizable civic leader, he -- more effectively than anyone else -- can help end the American epidemic of obesity. Torchia says, "As Governor of California, he has the power to influence, inspire and motivate people from all walks of life. I remember how he inspired me when I was 15 years old. Because of the Governor, I pursued my dream to compete in bodybuilding. And just as he has given back to the community, he motivated me to share with others all that I've learned in the field of health and wellness. It's clear to me that we both share a desire to see a healthier America, one in which obesity is not such an alarmingly serious health issue."

    The time has come in this country for a cultural shift toward health and wellness and away from the inherent dangers of obesity. Torchia proposes that legislation be enacted in California which forces food manufacturers to add warning labels to all food and beverage products containing ingredients known to be toxic to the human body. Food manufacturers and distributors, as well as any group making claims about the healthfulness of a food product, would have to follow strict regulations regarding those claims. They would also be required to provide guidelines for healthy, age-appropriate consumption of their products.

    People are unknowingly consuming goods, which directly and adversely affect their health. With this legislation, Torchia hopes to make Californians -- and eventually all Americans -- aware of the fact that long-term consumption of trans fats, artificial sweeteners and food dyes can lead to obesity and to the development of Metabolic Syndrome-X (MSX). This is a condition which weakens immune systems and makes people much more susceptible to type-2 diabetes, cancer, heart disease, and other crippling lifestyle diseases. Producers, distributors, and marketers of foods that contain toxins leading to the development of MSX should be held accountable for the ingredients in their products.

    Torchia says, "If we are successful, these manufacturers will be forced to reformulate their food products and provide healthier choices for consumers."

    Today, we are inundated with endless "convenient" food choices, many of which are extremely unhealthy. This coupled with the fact that most Americans say they are too busy for regular exercise, has helped to create a society of roughly 62 million obese adults. Further, the government's out-of-date healthy-eating guidelines make little sense to most people, Torchia said. And while public awareness of obesity may be increasing, the numbers of so-called "solutions" to this social problem are also increasing, with little positive results. This legislation would help people make healthy and informed choices about what they eat. Limiting toxins in our foods will allow people to live healthier, happier and more productive lives, he said. With political support on this life-or-death issue can be the start of a cultural shift in this country toward health and wellness.

    Legislation is a great first step toward solving the obesity epidemic, but education and awareness on a child-by-child basis are the keys to creating a healthier nation, he said. With that goal in mind, Torchia created "Children's Fitness Academy" (CFA), an innovative resource public and private schools can use to implement health and fitness education programs. CFA's team of professional fitness and education experts will work with schools to revise and update California's physical education programs as well as provide informative and engaging seminars on career opportunities in the health and fitness arena. In addition, a CFA task force will work to help implement awareness on a statewide level, Torchia said. Members of the task force will conduct research and police those targeted by the legislation, reporting their findings to your office, to the USDA, as well as to children and parents so that healthy and informed choices can be made. Torchia says, "As you can see, there is much work to be done to create this cultural shift. With CFA's unique plan for creating a healthier nation and political leadership, I believe we can guide the country toward a healthier way of life that will surely benefit those struggling to overcome obesity as well as generations of Americans to come.

    For further information:

    Company Name: Children's Fitness Academy

    Contact: Michael Torchia
    Office: 310.650.5595


    Michael Torchia
    Health and Wellness Expert


    "The test of the morality of a society is what it does for its children."

    Deitrich Bonhoeffer

  2. Anonymous12:14 AM

    Hospital Doesn't Understand Life, Hastens Death

    By Michael Torchia

    I wrote recently about my mother, a type-2 diabetic for most of her life, with a malfunctioning heart valve from birth. After age 80, she began having congestive heart failure attacks a few times a year. Every time she would have these attacks, I would fly out to Atlanta to help her with my expertise in holistic methods of healing and knowledge of nutrition.

    Shortly after my treatments, she recovered quickly and went back to a normal lifestyle. I realized the power and healing ability of energy work from years of working with Reiki Masters from around the world. In addition, I have studied and utilized Reflexology with all my clients for over 20 years.

    Two weeks ago, my mother had a heart attack and I immediately flew to Atlanta to help her recover. She was in the prestigious cardiac care center at Hospital in Buckhead, Georgia and doctors informed me that her body was slowly failing and she should be sent to a hospice to spend her last few days of life.

    Refusing to accept the doctor's suggestion, I reviewed her medical charts and medical stats on her heart monitor. I began utilizing music to help stimulate her heart rate. The mind controls how fast or slow the heart will beat. It is a proven fact that the heart beats to the beat of the music and we cannot control it, so I asked the nurses to play classical music to stabilize her heart rate and maintain her blood pressure.

    My mother's daily food chart showed she was barely consuming 500 calories a day which was causing her extremely weak condition and inability to talk coherently. After revising her food and water consumption, performing reflexology, energy work, giving her words of encouragement and lots of love, she made a dramatic improvement.

    She went off her most of her meds and was supposed to go through physical therapy and return home the following week.

    Unfortunately, after I returned to Los Angeles, the hospital doctors immediately moved to her to a general care section of the hospital and did not give her the personal care as we requested. The nursing staff went back to not feeding her enough calories, removed all monitoring equipment and never performed physical therapy, which was a crucial part of her recovery stage.

    Instead of attending to her needs they ignored her cries to help her sit up, because her back was severely cramping. After the nursing staff got tired of her pleading, they strapped her legs and arms down and doped her up with sleeping pills.

    Obviously, even in the most prestigious hospitals they do not believe in holistic healing and just rely on medicating patients. It is such a shame that most doctors have no respect for holistic methods of healing because they help people live better quality lives.

    My mother died November 4th, 2007, suffering from neglect, mistreatment and lack of proper care. Statistics from universities around the country prove our health care system is not working and people are dying that could of survived longer and better quality lives. My mother was such a blessed woman to live a long and happy life and did not deserve to suffer at the end, she deserved to pass gracefully...

    "Live like you are going to live forever and learn like you are going to die tomorrow."

    Michael Torchia

    Health and Wellness Expert