Archive for the ‘Health News Alerts’ Category


FDAThe FDA’s recently published guidelines on Stem Cell preparations entitled Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use brought much needed clarity as to where the agency intends to invest its regulatory efforts in the most promising area of Regenerative Medicine. In recent years, research on stem cells has skyrocketed, revealing and confirming their incredible healing potential and unleashing a flood of marketers looking to cash in on the lucrative opportunities they create.

Such opportunities always have and always will attract undesirable elements, such as rogue companies or practitioners who are eager to cash in on desperate but ignorant patients with low cost, inferior products or who adulterate their preparations with smallpox vaccine (to supposedly treat cancer) or fetal bovine serum (to accelerate the growth of cells – which is both potentially dangerous and illegal). To their credit, the agency (as well as the FTC) has dealt aggressively with obvious offenders and taken a stand against disingenuous practices such as marketing “amniotic stem cell” preparations as stem cells when in fact they contain no live stem cells.

The recently published FDA guidelines are a welcome blessing to consumers and a “shot across the bow” to those who have their own agenda in the “Wild West” environment that has ruled much of the industry to date. Best of all, the new guidelines put forth a clear picture from which the legitimate leaders in Regenerative Medicine can differentiate themselves by demonstrating best practices – and by which consumers can make informed treatment decisions.


As long as they meet certain requirements, human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are intended for transplantation into a human recipient are regulated by the FDA under Title 21 of the Code of Federal Regulations (CFR) Part 1271 and section 361 of the Public Health Service (PHS) Act. If an HCT/P does not meet the four criteria set out in 21 CFR1271, the HCT/P will be regulated as a new drug, device, and/or biological product under the FD&C Act and section 351 of the PHS Act (and therefore would require premarket approval and an Investigational New Drug (IND) Application which takes 5-10 years and $10-$20 million to complete).

In order to avoid being regulated as a new drug, an HCT/P must:

1. Be minimally manipulated.
2. Be intended for homologous use only.
3. Not combine the cells or tissues with another article, except for water, crystalloids or a sterilizing, preserving or storage agent, and
4. Not have a systemic effect and not be dependent on the metabolic activity of living cells for its primary function. Or if it does have a systemic effect or is dependent on the metabolic activity of living cells for its primary function, its use must be autologous, reproductive, or allogenic in a first-degree or second-degree blood relative.

In developing the so called “tissue rules” in section 361 of the PHS, the FDA focused on “public health and regulatory concerns including how transmission of communicable diseases can be prevented; what processing controls are necessary to prevent contamination that could result in an unsafe or ineffective product, and to preserve integrity and function so that the products will work as they are intended; and how clinical safety and effectiveness can be assured”.

These same concerns were the driving force behind the agency’s updated Guidelines, which focused primarily on the two criteria which arguably contribute most to mitigating risks and maximizing the safety and efficacy of HCT/Ps: minimal manipulation and homologous use.

Minimal Manipulation

In defining minimal manipulation, the agency made a very important and insightful distinction between the processing of stem cells harvested from structural tissue (such as placenta, umbilical cord, or fat tissue) or nonstructural tissue (such as cells found in umbilical cord blood, reproductive cells, glands and organ tissues). HCT/Ps that physically support or serve as a barrier or conduit, or connect, cover, or cushion in the donor are generally considered structural tissues, and those that serve metabolic or other biochemical roles in the body such as hematopoietic, immune or endocrine functions are generally considered cells/nonstructural tissues.

For structural tissue, processing may not alter the original relevant characteristics (such as strength, flexibility, cushioning or covering) of the tissue relating to the tissue’s utility for reconstruction, repair or replacement. So if you take adipose (fat) tissue and break it down using enzymes in order to gain access to the stem cells it contains, you compromise its structural integrity irreversibly and it could not go back to performing its prior function in the body of the donor. The FDA guideline makes the determination of whether an HCT/P is minimally manipulated based upon the effect of manufacturing on the original relevant characteristics of the HCT/P as it existed in the donor prior to recovery and any processing that takes place (and not on the intended use of the HCT/P in the recipient).

Adipose stem cell procedures clearly do not satisfy the minimal manipulation requirement because the processing required of adipose tissue alters its utility regarding providing cushioning and support. Similarly, if you chop and grind up umbilical cord or placental tissues and treat them with enzymes to gain access to the stem cells therein, the structural integrity of the tissue is forever compromised and the minimal manipulation standard has not been met.

For cells or nonstructural tissues, the guideline states that processing may not alter the relevant biological characteristics (i.e. – the differentiation or proliferation potential or metabolic activity) of the cells or tissues. Because of their minimal processing, stem cells harvested from umbilical cord blood clearly do pass the minimal manipulation standard.

Incidentally, the processes used to harvest and prepare stem cells from bone marrow aspirate would also not likely be considered minimal manipulation, but for whatever reasons, bone marrow enjoys special status and is excluded from being considered an HCT/P.

Homologous Use

Section 1271.10(a)(2) states that in order for an HCT/P to qualify, it must be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” This means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P must perform one or more of the same basic functions in the recipient as in the donor.

Basic functions of a structural tissue would generally be to perform a structural function such as to physically support or serve as a barrier or conduit, or connect, cover or cushion.

The basic functions of umbilical cord include serving as a conduit for blood flow from a mother to her fetus. If umbilical cord is mechanically and enzymatically processed and used to treat musculoskeletal conditions by regenerating or promoting the generation of articular cartilage or tendon, this would not be considered homologous use because regenerating or promoting the regeneration of cartilage or tendon is not a basic function of umbilical cord tissue.

Basic functions of a cellular or nonstructural tissue would generally be metabolic or biochemical functions, such as hematopoietic, immune or endocrine functions. Umbilical cord blood contains a myriad of specialized cells that are responsible for a vast array of metabolic functions pertaining to the development and maintenance of a fetus, any number of which might be harnessed and deployed for homologous use in a recipient seeking regenerative support of targeted tissues.

For example, the most common use of umbilical cord blood stem cell preparations is promoting healing and regeneration of damaged tissues in knee or other joints. This is accomplished by inhibiting inflammatory immune responses in the damaged or underlying tissues, providing growth factors and other trophic nutrients, and revitalizing the body’s own stem cells – thereby creating an optimal environment for healing and regeneration – and clearly a homologous use for the umbilical blood sourced cells.


The FDA is allowing 36 months to give manufacturers time to determine if they need to submit an IND Application in light of the new guidelines, and intends to exercise enforcement discretion unless an HCT/P is deemed to present a significant safety concern. Meanwhile, the agency will focus enforcement actions on products with higher risk, taking into account factors such as where the cells or tissues are sourced and route and site of administration. Actions related to procedures associated with higher risk (such as IV injection or infusion, aerosol inhalation, intraocular injection or injection or infusion into the central nervous system) will be prioritized over those associated with a lower risk (such as intradermal, subcutaneous, or intra-articular (joint) injections).

The FDA is more likely to target practitioners that are actively marketing systemic applications for the prevention or treatment of serious and/or life threatening diseases and conditions, allegedly because there is less basis on which to predict the product’s behavior in the recipient, but also because the use of “unapproved” stem cell products may cause patients to delay or discontinue medical treatments that have paid the price to be deemed safe and effective by the agency (i.e. – drugs and surgery).


So how did the recently published FDA guidelines change the landscape of Regenerative Medicine for the established players in terms of regulatory concerns and long term positioning in the marketplace?

Bone Marrow – Stem cell therapy started with bone marrow transplants many years ago, and its status from a regulatory standpoint was virtually unaffected by the new guidelines. It will likely remain a mainstay treatment (especially for musculoskeletal specialists such as orthopedic practitioners) because of its long established practice – even though the results it offers are inconsistent at best because they are so dependent upon the age and health of the patient – who also must endure the added risk, pain and discomfort of the harvesting procedure.

Adipose (Fat) – Practitioners who have made substantial investments into equipment and training to harvest and process stem cells and perform transplants from their patients’ own adipose tissue are most adversely affected by the new guidelines which clearly demonstrate that adipose stem cell preparations do not qualify under either the minimal manipulation or the homologous use definitions in the guidelines.

Such procedures will eventually be abandoned in favor of other stem cell sources, and the sooner the better. Adipose derived stem cells have been shown to have inferior growth kinetics, potency and viability compared to other sources – possibly due to the fact that our fat is where toxins are stored by the body, and like all autologous stem cells (derived from the patient who is also the recipient), their efficacy is greatly dependent on the age and health of the patient.

Amniotic – Amniotic “Stem Cell” companies have already been under fire by the FTC for marketing stem cells when their products contain no live stem cells by virtue of the way they must be processed by law. To add insult to injury, their products also run afoul of the new guidelines, not qualifying under either the minimal manipulation or homologous use guidelines for HCT/Ps. One exception would be the use of amniotic membrane as a skin covering on a burn patient which would be considered homologous use.

Neonatal Structural Tissues (Umbilical Cord, Wharton’s Jelly, Placenta, etc.) – Because these are structural tissues, the processing requirements in order to harvest the stem cells they contain do not appear to qualify under the minimal processing or homologous use guidelines either.

As the guidelines point out, structural HCT/Ps generally raise different safety and efficacy concerns than do cells or nonstructural tissues. The FDA appears to recognize and appreciate that the processes required to harvest stem cells from adipose or structural neonatal tissues are not only detrimental to the potential number and integrity of the stem cells harvested, but they may introduce new and undesirable risks (such as contamination, infection or inadequate undifferentiation of harvested cells).

Umbilical Cord Blood – As a distinctly cellular (nonstructural) tissue, the processing of stem cells from umbilical cord blood clearly qualifies under the minimal manipulation guideline, and their metabolic functions in the donor and recipient are certainly applicable under the homologous use guideline as well. So companies that manufacture stem cell preparations from umbilical cord blood emerged as by far the greatest beneficiaries of the new guidelines (as long as they don’t advertise or promote the systemic use of their stem cells).

However, unless they are properly processed, umbilical cord blood derived stem cell preparations still present the practical hazard of blood matching and blood antigen rejection issues in the host. Please note, at least one company has perfected the task of removing all red blood cells, fragments and antigens from cord blood at this time. It is only a matter of time before others will follow suit, and this will be a blessing to consumers and practitioners alike.

Cord blood derived stem cells deliver all the advantages of neonatal sourcing (higher cell counts, better cell viability, and greater potency) which leads to more consistency, enhanced efficacy and better patient outcomes – a win/win for doctors and patients alike.


The Future of Medicine Has Arrived!

Carson B. Burgstiner MD was a pioneer in the field of Regenerative Medicine, practicing and promoting preventive health strategies that were well ahead of his time and transforming innumerable lives under the guiding principle that “If you maintain normal physiology, you can prevent disease and pathology”. Having enjoyed the privilege of testing and expanding Dr. Burgstiner’s legacy for the last twenty years, we have seen that his philosophy of restoring integrity to the bioterrain through the Burgstiner Wellness Protocol not only prevents chronic illnesses, but may often times even reverse them.

My father was a strong proponent of glandular therapy, an ancient form of medicine in which a patient may strengthen the health and function of a troubled gland by consuming corresponding glandular tissues of another species. Dr. Burgstiner’s clinical experience and research demonstrated that the efficacy of glandular extracts could be profoundly enhanced by combining them with various vitamins, minerals and other cofactors that serve to activate their expression.

Dr. Burgstiner recognized the unique promise and incredible utility of glandular extracts because “when you ingest glandular tissues, not only are you getting gland – specific nutrients, but you are getting information encoded in the genetic material of those proteins that cannot be conveyed in any other way… and certainly not with a drug.” Since my father’s untimely death in 1996, many advancements have been made in biologics and Regenerative Medicine, but none more exciting than the explosion of research surrounding the vast potential of human stem cells.

Scientists at first believed that once stem cells were transplanted, they went to work by differentiating into whatever tissues were needed and then replicating themselves as needed. However, research has shown that their primary mechanism of tissue repair stems from their role as messenger or signaling cells.

Much like glandular therapy, transplanted stem cells exert their amazing and sometimes miraculous influence by transmitting critical information to damaged or dying cells in the form of growth factors, cytokines, chemokines and signaling proteins. Indeed, last year Dr. Arnold Caplan (the eminent research scientist considered to be the “Father of Mesenchymal Stem Cells”) petitioned the scientific community to change the name of MSC’s to “Medicinal Signaling Cells” because of their unique ability to activate or rejuvenate endogenous stem cells and tissues.

Lets take a closer look at stem cells and see how they are changing the landscape of medicine.

What are Stem Cells?

Stem cells are a class of remarkable cells that can develop into any type of cell, and form the basis of human development and maintenance. A stem cell is essentially a “blank” cell, capable of reproducing or becoming another more differentiated cell type. Once sperm meets egg and a blastocyst is formed, embryonic stem cells are responsible for the normal development of the zygote into an embryo.

Scientists learned how to remove embryonic stem cells from the inner cell mass of human embryos in 1998, but the moral implications of destroying them – along with the implications of human cloning – resulted in a 2001 law prohibiting the creation of embryos for research purposes and limiting federal funding for embryonic stem cell research to a study of 70 or so existing cell lines. There are also unresolved safety concerns with embryonic stem cells because they are capable of transmitting DNA into the cell nucleus of a host – possibly with unintended consequences.

Embryonic stem cells continue to hold great promise in medicine (as do IPSC’s – or Induced Pluripotent Stem Cells – which are cells that have been genetically manipulated into stem cell – like cells), but for the purposes of this discussion, we will be focusing only on non-embryonic stem cells, which do not pose such safety concerns. There are different types of non-embryonic stem cells in our bodies. Hematopoietic stem cells (HSCs) are blood stem cells that give rise to all components of blood. Mesenchymal stem cells (MSCs) or stromal cells have shown much promise in various disease states as they can give rise to a multitude of cell types found throughout our body such as fat, bone, cartilage and muscle.

MSCs release growth factors and proteins to communicate and stimulate neighboring cells, “homing in” on inflammatory signals to stimulate repair and/or replacement of damaged or diseased tissues. They regulate the immune system by increasing the response of regulatory T-cells and decreasing pro-inflammatory mediators such as TNF-α, and IFN-γ. Because of their immune modulating effects, MSCs may be used from an unrelated donor.

Where Do Stem Cells Come From?

Non-embryonic stem cells can be harvested from a variety of sources including: bone marrow, adipose (fat) tissue, placenta and cord tissue, and umbilical cord blood. Adult stem cells have been found in the brain, bone marrow, blood vessels, skeletal muscle, skin, teeth, heart, gut, liver, and other organs and tissues.

For purposes of stem cell therapy, doctors most often use stem cells harvested from your bone marrow or adipose tissue, cells harvested and prepared by a lab from irradiated neonatal tissues or amniotic fluid, or they can use live stem cells properly harvested from umbilical cord components or blood.

Are Stem Cell Treatments FDA Approved?

Stem cell treatments are not specifically FDA approved; they are considered investigational, but are permissible. Most patients do not realize this, but many of the treatments they receive on a weekly or yearly basis are technically not “FDA approved”. One example of this is the prescribing of any medication in an “off-label” fashion.

Stem cells are collected, processed, rigorously tested and distributed under the FDA guidelines for Human Cellular and Tissue based Products (HCT/P) (21 CFR Part 1271), 361 human cell and tissue product, state regulations and guidelines of the American Association of Tissue Banks (AATB).

What is the Evidence For Effectiveness and Safety For Using Stem Cells and Bio-Restorative Treatments?

The evidence is surprisingly robust and growing rapidly (there are currently over 5800 clinical trials published on stem cells in the international database). There are numerous scientifically rigorous studies (clinical and laboratory based) that support both the effectiveness and safety of these treatments. Among other things, clinical trials using MSC’s have been conducted for suppression of GVHD (Graft Versus Host Disease), severe autoimmune diseases, repair of skeletal tissue, amyotrophic lateral sclerosis, chronic spinal cord injury, non-healing chronic wounds, vascular disease, coronary artery disease and myocardial infarction. Currently, the largest number of clinical trials is in patients with heart disease.

Due to FDA and FTC regulations, stem cell companies cannot promote (advertise) the use of stem cells for systemic (IV) applications, and most injections are still being done as an alternative to knee or hip replacement, to ease joint pain or peripheral neuropathy, or to reverse tendon or ligament damage. However, many practitioners are very successfully treating chronic illnesses and autoimmune disorders using mesenchymal stem cells (and the published studies on stem cells and Lyme Disease, MS, Lupus, Parkinsons, and many others are indeed impressive).

Despite the incredible potential that stem cells bring to Regenerative Medicine and the clinical success stories associated with them, there is cause for sober caution and sound judgement in regard to their use. As we shall see, all stem cell preparations are not equally effective, and unfortunately, some players in the market are more interested in short term profits than long term positive outcomes.

What Kind of Stem Cells Should I Consider and Why?

Even though we all have our own adult stem cells, there are substantial drawbacks to harvesting and transplanting your own. First, to remove and then reintroduce adult stem cells from your body requires a surgical procedure (bone marrow aspiration or liposuction), which as in every procedure, carries some risk along with considerable pain and discomfort. Second, our stem cells age as we do and their numbers and potency decline dramatically with age. Finally, there is scientific evidence demonstrating that adult stem cells from a diseased patient are not as effective as those from a healthy one.

Progressive Declining Gene Expression of Stem Cells

Once we are born, our stem cells go through three distinct phases of gene expression during the human life cycle. Early in life, our stem cells are programmed for rapid growth and differentiation, and they are most active and numerous during the early stages of human growth and development. From puberty until middle age, our stem cells are expressing genes that lead to slower growth and maturation. In later years, our stem cells – which are progressively declining in numbers, potency and viability – are all about maintaining what is left of our health. So why would anyone want to use adult stem cells that are less viable and programmed for maintenance when they could use new cells that are bursting with life and programmed for rapid growth and differentiation?

Obviously there are strategic advantages to using neonatal stem cells that are young and vibrant, but there are also challenges. Some practitioners use preparations harvested from amniotic fluid which are somewhat effective for intra-articular applications (joints), but with significant limitations due to federally mandated processing requirements for amniotic fluid which require that it be flash frozen before processing – which destroys the stem cells therein. Amniotic stem cell preparations contain many of the growth factors and signaling proteins produced by MSC’s (which is why they are somewhat clinically effective), but their diminished effects are not sustained since there are no live stem cells present to continue producing them.

Zeroing in on the potential superiority of neonatal tissues, some stem cell companies have turned their attention to various umbilical cord tissue components (such as Wharton’s Jelly) to produce their regenerative preparations, but the results are once again disappointing. Because of the complexity, harshness and time consuming nature of the process required to harvest and isolate the stem cells, these preparations produce relatively few live stem cells, and with a low percentage of viability.

A Giant Leap Forward

The umbilical cord serves as a conduit of a vast array of nutrients for a developing fetus. Oxygenated nutrient rich blood is carried from the placenta to the fetus until the baby is born. Cord blood is rich in primitive stem cells, growth factors and immune cells that are naïve as they have to be compatible for baby and mother. The healing potential of umbilical cord blood (UCB) derived stem cells is exponentially greater than using adult stem cells, many of which have already become senescent (unable to grow, divide and secrete vital proteins) to varying degrees.

Unlike amniotic fluid and placental tissue, cord blood is not required by law to be flash frozen or irradiated before it can be processed under AATB regulations, so the integrity and viability of its life giving milieu of cells can be preserved through the combination of a gradual cryopreservation technique and using nontoxic agents that alter cell membrane permeability to prevent crystallization and cellular destruction during freezing. UCB derived MSC’s demonstrate superior efficacy to adult stem cells, with exponentially greater proliferation potential and a much lower senescence rate – which translates into enhanced potency, greater anti-inflammatory effects, better immune modulatory effects, and a more pronounced and sustained clinical result.

Stem cells from Umbilical Cord Blood are harvested from healthy full term births (typically planned C Sections) from parents that have been screened for social hazards and infectious diseases. At the moment, it appears that the vast array of undifferentiated and immune regulating neonatal cells and signaling proteins that find their unique origin in umbilical cord blood present the most potent, consistent and profound asset available in the world of Regenerative Medicine.

As Coach Lee Corsi of ESPN says, “Not So Fast!”

Proponents of autologous adult stem cells (harvested from your own body) are quick to point out valid concerns about blood matching and rejection issues associated with blood or tissue based products that are not your own. The red blood cells, fragments and blood antigens (as well as Type II Histocompatibility proteins such as HLA-DR that are associated with host vs graft disease) found in cord blood might indeed pose a problem if not properly removed from a stem cell preparation prior to injection into a host. Therefore, a company that could master the challenge of removing these proteins and freeing it from all rejection and blood matching concerns would truly possess the Gold Standard in Regenerative Medicine – with consistent and profound healing properties unlike anything else that can be found here in the United States.

The Blessing

Actually, there is such a company, and we have recently partnered with them to share their amazing technology with the world and push forward the boundaries of medicine. Like my father’s discovery of how combining vital nutrient factors with glandular therapy potentiated its benefits, we are now using targeted nutrition to augment the regenerative powers of stem cells. What a blessing it is to carry on with my father’s legacy on the cutting edge of medicine.


Int. J. Mol. Sci. 2013, 14, 17986-18001; doi:10.3390/ijms140917986
Comparative Analysis of Human Mesenchymal Stem Cells from Bone Marrow, Adipose Tissue, and Umbilical Cord Blood as Sources of Cell Therapy
Hye Jin Jin 1,2,†, Yun Kyung Bae 1,†, Miyeon Kim 1, Soon-Jae Kwon 1, Hong Bae Jeon 1, Soo Jin Choi 1, Seong Who Kim 2, Yoon Sun Yang 1, Wonil Oh 1 and Jong Wook Chang

Tissue Eng Part B Rev. 2014 Oct;20(5):523-44. doi: 10.1089/ten.TEB.2013.0664. Epub 2014 Apr 22.
Umbilical cord mesenchymal stem cells: the new gold standard for mesenchymal stem cell-based therapies?
El Omar R1, Beroud J, Stoltz JF, Menu P, Velot E, Decot V.

Srp Arh Celok Lek. 2013 Mar-Apr;141(3-4):178-86.
Mesenchymal stem cells isolated from peripheral blood and umbilical cord Wharton’s jelly.
Trivanović D1, Kocić J, Mojsilović S, Krstić A, Ilić V, Djordjević IO, Santibanez JF, Jovcić G, Terzić M, Bugarski D.

Promising new potential for mesenchymal stem cells derived from human umbilical cord Wharton’s jelly: sweat gland cell-like differentiative capacity.
Xu Y, Huang S, Ma K, Fu X, Han W, Sheng Z.
J Tissue Eng Regen Med. 2012 Aug; 6(8):645-54. Epub 2011 Sep 13.

Pluripotent gene expression in mesenchymal stem cells from human umbilical cord Wharton’s jelly and their differentiation potential to neural-like cells.
Tantrawatpan C, Manochantr S, Kheolamai P, U-Pratya Y, Supokawej A, Issaragrisil S.
J Med Assoc Thai. 2013 Sep; 96(9):1208-17.

Isolation and Characterization of Mesenchymal Stromal Cells from Human Umbilical Cord and Fetal Placenta.
Beeravolu N, McKee C, Alamri A, Mikhael S, Brown C, Perez-Cruet M, Chaudhry GR.
J Vis Exp. 2017 Apr 3; (122). Epub 2017 Apr 3.

Mesenchymal Stem Cells: Time to Change the Name!
Caplan AI.
Stem Cells Transl Med. 2017 Jun;6(6):1445-1451. doi: 10.1002/sctm.17-0051. Epub 2017 Apr 28.
PMID: 28452204

New MSC: MSCs as pericytes are Sentinels and gatekeepers.
Caplan AI.
J Orthop Res. 2017 Jun;35(6):1151-1159. doi: 10.1002/jor.23560. Epub 2017 Apr 11. Review.
PMID: 28294393

Mesenchymal stem cells: environmentally responsive therapeutics for regenerative medicine.
Murphy MB, Moncivais K, Caplan AI.
Exp Mol Med. 2013 Nov 15;45:e54. doi: 10.1038/emm.2013.94. Review.
PMID: 24232253

Defining human mesenchymal stem cell efficacy in vivo.
Bonfield TL, Nolan Koloze MT, Lennon DP, Caplan AI.
J Inflamm (Lond). 2010 Oct 25;7:51. doi: 10.1186/1476-9255-7-51.
PMID: 20974000

Yang et al. Journal of Translational Medicine 2010, 8:75
Safety evaluation of allogeneic umbilical cord blood mononuclear cell therapy for degenerative conditions
Wan-Zhang Yang1, Yun Zhang2, Fang Wu1, Wei-Ping Min3, Boris Minev4, Min Zhang1, Xiao-Ling Luo2, Famela Ramos5, Thomas E Ichim5, Neil H Riordan5†, Xiang Hu2*†

Will the Battle to Require GMO Labeling Begin and End in California?

Monsanto and other pesticide and biotech giants have invested heavily to thwart proposed California legislation to require mandatory labeling of foods containing genetically modified ingredients. Proposition 37 asserts that we the citizens have the right to know if our food has been genetically engineered.

Predictably, opponents of the bill claim that if passed, it will increase food costs without positively impacting the safety of the food supply. However, the results of a recent two year French study –the first ever conducted to examine the LIFELONG effects of exposure to GMO corn on rats – sent shock waves through the scientific community.

Rather than stopping the study at 90 days as all previous studies had done (curious isn’t it?), the French scientists discovered that beginning at 120 days of exposure, the rats developed massive tumors , organ damage, and progressive illness leading to early death.

Most European countries have already mandated clear labeling of GMO foods, but as usual, corporate interests in the U.S. have so far outpaced the interests of Americans. Ground zero in the battle for your right to choose not to serve your family frankenfoods is in California.

If Prop 37 is accepted and GMO ingredient disclosure is required in California, food companies will face a tough PR challenge by not extending GMO label disclosure to other states. Therefore, a win in California leads to a win for all of us.

If the measure is defeated in California, where else can we hope to do better? The answer is nowhere. We will likely be cursed with hidden GMO’s for the foreseeable future… and based upon the French study results, a scary and tragic future indeed.

What Can You Do?

Make sure that this issue is not buried within your realms of influence… especially if you have any contacts who can vote or influence a vote in California in the upcoming election. To learn more about Prop 37 and how you can support it, click here .

Action Alert: Dietary Supplements Targeted With More Unnecessary Regulations

Take Action
Ask Your Senators to Oppose Senator Durbin’s Amendment
Unnecessary new regulations on this industry are not needed.

Senator Durbin (D-Ill.) has introduced an amendment to the Food and Drug Administration Safety and Innovation Act (S. 3187) that would impose needless regulation on the dietary supplement industry. The Natural Products Association (NPA) asks you to contact your senators and ask them to vote no on Durbin Amendment 2127. The amendment would add the following to the current registration requirements for dietary supplement manufacturers: (1) a description of each dietary supplement product manufactured by the facility, (2) a list of all ingredients in each dietary supplement product, and (3) a copy of the label and labeling for each product. These facilities would also be required to submit additional registration if the facility begins manufacturing a new product or a reformulated product, or ceases producing a product for which the facility previously submitted a registration.

Senator Durbin’s amendment adds layers of unnecessary bureaucracy, without addressing the real problem. NPA believes that the FDA has the necessary authority to regulate dietary supplements. However, the FDA has not received adequate funding to execute these powers properly. These expanded requirements would overwhelm the FDA and would not further FDA’s mission to protect the public health.

Please take a moment and email your senators and ask them to OPPOSE Durbin Amendment 2127.

To go to the NPA website and take action, Click Here.

Holiday Shoppers Beware: Those Receipts May Be Deadly!

thermal receipt This most excellent advice comes from Dr. Al Sears who has a great newsletter:

I guess I’m supposed to get excited about all the holiday shopping going on and the deals you can get on days like Black Friday. But to me it just means it takes longer to get the same things done. The lines, the crowds… and the discounts don’t thrill me. I’d rather be somewhere else.

So I really don’t think of Black Friday as a good thing. I think it’s named appropriately.But if you do go shopping, there’s something you should know about your health.

I’m talking about the little slip of paper you tuck into your pocket or purse every time you buy anything. From gas to all those Christmas presents you’re getting for all your friends and family this week.

That receipt is most likely covered with bisphenol A (BPA) – the cancer-causing, estrogen-mimicking chemical.

Paper receipts are coated with BPA to get the ink from the receipt printer to develop on the paper. Problem is, BPA doesn’t stay on the receipt, making it easy to be absorbed by anyone handling the paper.

What’s worse is that a new study found that BPA transfers readily from receipts to skin and can penetrate the skin to such a depth that it cannot be washed off.1

BPA is dangerous, even in small amounts. Studies show that it may cause cancers, diabetes, heart disease, obesity, and more.

Nearly every modern register uses this kind of paper. And every one of those receipts, according to new research, contains from 250 to 1,000 times more BPA than a plastic water bottle or soda can lining. Several states, and Canada and Europe, have banned using BPA in some of those kinds of products.

Two other new studies looked at how much of the BPA from each receipt gets from your skin into your bloodstream.

One looked at 15 different types of paper products. including thermal receipts, flyers, magazines, tickets, mailing envelopes, newspapers, food contact papers, food cartons, airplane boarding passes, luggage tags, printing papers, business cards, napkins, paper towels, and toilet paper, collected from several cities around the world.

Thermal papers accounted for 98% of the BPA you are exposed to.

The second study says that you absorb as much as 60% of the BPA you get on your skin.2 Fortunately, there are some good ways to avoid taking in BPA while you’re doing your seasonal shopping.

First, the easiest way to avoid getting BPA on your hands is to decline getting a receipt. If you don’t need a receipt, leave it and ask the cashier not to print it if possible. For many small purchases and unless you’re purchasing something you may want to take back, you probably don’t need one anyway.

Second, shop at stores that don’t have thermal printers that use BPA. The Environmental Working Group’s research shows that some of the stores that use BPA-containing receipts in at least some outlets include McDonald’s, CVS, KFC, Whole Foods, Wal-Mart, Safeway and the U.S. Postal Service.  Receipts from some major chains including Target, Starbucks and Bank of America ATMs issued receipts that were BPA-free or contained only trace amounts.3

Third, handle your receipts as little as possible, and make sure you wash your hands the right way when you get home. Washing your hands is one of the quickest, safest, easiest and most overlooked things you can do to protect your health on many levels. Unfortunately, few of us do it properly. Keep these three things in mind:

1.    You don’t need a special soap. Expensive antibacterial soap is a waste of money and can contain toxic chemicals. Same goes for hand sanitizers.

Ordinary, plain, unscented soap is the best. It kills just as many microbes and bacteria as antibacterial soap. A U.S. FDA advisory committee found that use of antibacterial soaps provides no benefits over plain soap and water.4
2.    Your choice of hot or cold water makes no difference. For comfort, I like warm water.
3.    The length of time washing your hands is important. Twenty seconds is the optimum length – that’s about the time it takes to sing the “Happy Birthday” song – twice.
4.    Make sure you rinse the soap off your hands with running water and dry them well – preferably on a disposable paper towel.



1. Biedermann, S., Tschudin, P., Grob, K. "Transfer of bisphenol A from thermal printer paper to the skin." Analytical and Bioanalytical Chemistry. Volume 398, Number 1, 571-576.
2. Mielke H, Partosch F, Gundert-Remy U. "The contribution of dermal exposure to the internal exposure of bisphenol A in man." Toxicol Lett. 2011 Jul 28;204(2-3):190-8.
3. Lunder, S. "Synthetic estrogen BPA coats cash register receipts." EWG. July 27, 2010. Retrieved Nov. 17, 2011.
4. "Wash those hands, but avoid Triclosan." EWG. Retrieved Nov. 17, 2011.

Is Your Tap Water Medicated?

tap water Check out this video from my cherished friend, Dr. Chris Meletis:

Sneak Attack on Supplements: FDA and Senator Durbin Use Slow News Day to Launch

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Sneak Attack on Supplements: FDA and Senator Durbin Use Slow News Day to Launch

Today, both the FDA and Sen. Dick Durbin (D-IL) dropped policy “bombs” on those of us who use dietary supplements. It is no mere coincidence that both were released on the Friday before a holiday weekend. By timing the introduction of their anti-supplement legislation and regulatory guidance this way, the FDA and Sen. Durbin are both hoping to evade negative publicity. We think it is better to keep American citizens fully informed, and with your help, we will get the word out. Please send this communication far and wide.

First, the FDA has issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained by the Dietary Supplement Health and Education Act (DSHEA). As you may recall, DSHEA said that supplements already on sale prior to the passage of the act were "grandfathered" in, and did not have to be reviewed by the FDA. New supplements developed after the Act have been in a kind of limbo waiting for the FDA to spell out the procedures to be followed.

These new supplements have always been at risk because of the uncertainly surrounding their regulatory status. And many of these new supplements are extremely important for our health. We won’t name them, because to do would be to put a bull’s-eye on them for the FDA to shoot at, but you would recognize many of them and may be currently taking them.

DSHEA was passed in 1994. The FDA has thus taken seventeen years to provide regulatory guidance for these new supplements. Now a draft version of guidance is here, and it isn’t good. It is just another effort by the FDA to suffocate the supplement industry so that everything—supplements and drugs alike—will go through the vastly expensive drug approval process, a process that pays for FDA salaries.

We have said it before and we will say it again. Supplements cannot usually be patented. No non-patentable substance can be taken through a drug approval process that on average costs a billion dollars. If supplements are treated like drugs, there simply won’t be any supplements. The FDA knows this perfectly well.

The new draft guidance is written in the usual regulatory non-English, but buried within it are definitions of "new supplements" that will make more and more supplements subject to the new rules. The rules themselves are designed to make it harder and harder to market new supplements, all of which will need to submit notification to an agency that is fundamentally hostile to the supplement industry. Not only does each supplement require its own notification, a separate notification must be submitted by each company that offers it. Additionally, notification must be submitted again if the supplement is reformulated in any way or offered in combination with any other supplement or ingredient. Based on what the FDA has done in the past, many more applications will be rejected than accepted and the cost of the whole process will be high.

The FDA is required to give us 90 days to comment on their proposed guidance. Our experts are busy analyzing the proposal in all its detail and we will report on it again and provide an Action Alert in our next newsletter right after the holiday. We already know this needs to be stopped. With your help we will do everything we can to change it. Your ability to use supplements not already documented as having been on the market under the same exact name and formulation prior to 1994 will depend on it.

As we mentioned above, Sen. Durbin’s much-feared Dietary Supplement Labeling Act of 2011 (S.1310) has been formally introduced in Congress. The language is not available online yet, but the draft procured by ANH-USA yesterday reaffirmed the analysis we sent you earlier this week. Look for our in-depth article and Action Alert on S.1310 in our newsletter on Tuesday, July 5th!

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