Tuesday, October 23, 2012

NeriumAD Safety Information


Dennis Knocke, CEO of Nerium Skincare, sent us the below memo to summarize the recently held North American Congress of Clinical Toxicology meeting, and the discussions about NeriumAD at this meeting. He also included a link to a video of some of the top doctors in this field discussing the safety of NeriumAD at this gathering. This is a must-read memo and must-watch video for all. It is important to be armed with knowledge on this topic so you can easily disarm any misconceptions. 

I just returned from our annual visit to the North American Congress of Clinical Toxicology (NACCT) meeting in Las Vegas. As usual, we exhibited and shared product safety information and provided NeriumAD Age-Defying Treatment product samples to the attending MD, PhD, PharmD, FDA, FBI Toxicologist/Pharmacologist and Poison Control Center Directors, etc. We were also able to capture some video on NeriumAD safety, which can be viewed at www.neriumadsafety.com.
I am very excited about how well this year’s meeting went. First, we initiated a new system to provide for feedback from individuals receiving samples. This feedback from several hundred of these healthcare professionals will only add to our safety data. We also received very positive feedback from individuals who had taken samples last year. 
Second, and more important, we were able to organize a NeriumAD Safety Panel Presentation/Discussion at the meeting. The panelists included five independent MD, Pediatric MD, PhD, PharmD, and professors of Pharmacology and Toxicology, one a former Medical Officer for the Food and Drug Administration. Needless to say, it was a very distinguished panel with the ability and credibility to speak to safety; and recognizable individuals to the members of the North American Congress of Clinical Toxicology. The presentation/discussion included the review of Dr. Newman’s research and ST&T clinical data, a review of the data base of the American Association of Poison Control Centers as it relates to Nerium oleander, comments about the confusion associated with the generic term “oleander,” comments about what is credible information on the Internet and myths about Nerium oleander, toxicity of NeriumAD as it relates to children, comparison to other safe products that contain toxic compounds, and the final consensus on the safety of NeriumAD. The conclusion of the panel was that NeriumAD was safe. I will share an overview of the presentations, discussion, and comments of this panel. 
Since you are aware of Dr. Newman’s and ST&T’s research, I will start with commentary pertaining to toxic plants, where one panelist (a director from one of the Poison Control Centers, who has studied the National Poison Control Center database of all reports from plant-based poison incidents) commented specifically about Nerium oleander. He shared that the term “oleander” needs to be put in a generic term. There is Nerium oleander (used in NeriumAD), which is often mistaken for a different plant called Thevetia peruviana (referred to as yellow oleander), This yellow-flowered plant is responsible for a large number of toxic reports and is often confused as oleander in a generic sense. So when you hear “Nerium oleander,” you may confuse it with a plant which has a much more poisonous, toxic reputation, when it actually is not poisonous. This toxicologist’s word of advice was to not believe everything you read on the Internet relating to plants, particularly relating to Nerium oleander. 
He referenced a number of myths that circulate about Nerium oleander and have been referenced on the Internet. As an example, one myth is that one leaf of Nerium oleander will kill a child. Another is that a group of Boy Scouts roasted hot dogs on Nerium oleander sticks and, as a consequence, all died. He referred to these examples as strictly myths. He shared his research on a rather large database that contains case studies of plant poisonings from the American Association of Poison Control Centers. He shared the unintentional and intentional data and put the data in perspective. In about 2.3 million plant exposures over the last 25 years, there have been only 43 deaths due to plant ingestion in the United States. None of them have involved Nerium oleander, and there are absolutely no fatalities associated.
A summary of the comments of another Pediatric MD at a prominent children’s hospital and Professor of Toxicology and Pharmacology are as follows. The amount of oleander in the entire container of NeriumAD is a non-toxic dose, even to children. He went on to estimate that a one-year-old child could ingest the entire contents of 400 bottles of NeriumAD and it would still remain a non-toxic dose of NeriumAD. In addition, he commented that in all his years of experience, young children do not ingest significant volumes of creams and ointments. He shared that in his 40 years of private practice and experience with his associated Poison Control Center, he is not aware of even one death of a child by ingestion of creams or ointments, as young children are just not wired to ingest large quantities of these types of substances. He proceeded to comment on the NeriumAD container design and shared that the container presented a daunting challenge for the extraction of significant volumes of cream by adults, let alone young children. 
Another MD, PhD, Medical Pharmacologist and Toxicologist shared a quote from Paracelsus (1493-1541), who said, “All things are poison and nothing is without poison.” However, “the dose makes the poison.” He noted that humans use and consume daily foods which are known to contain trace amounts of natural carcinogens and toxins (apricots, apples, tea, cocoa, coffee, cherries, black pepper, mushrooms, etc.). The risk is relative and it is “the amount consumed” that matters. He presented some examples of food containing toxins, such as potatoes and tomatoes, which contain Gycoalkaloids and Solenines. In addition, almonds, apricots, and cherries contain Cyanogenic Glycosides, castor beans contain Ricin, puffer fish contain Fugu, rhubarb contains xalates, and mushrooms contain Muscarine. 
He also noted that Botox is one of the most toxic chemicals we have, but it has been possible to adjust the dose, allowing it to be used by thousands of individuals. He went on to cover ED50, TD50, LD50, Dose/Response Curve, Therapeutic Index, Margins of Safety, etc. At the end of the day, he commented that, “As a result of the studies, the study design, and data captured, NeriumAD has no evidence of toxicity and no absorption into the systemic circulation.” He concluded that the NeriumAD product is perfectly safe to use.
I should mention that at the end of the presentation, the best part was when one of the attendees stood up and announced that she had been using NeriumAD for a year now and loved it. In closing, this was a great meeting for all of us and I think the video will speak for itself.

Saturday, October 20, 2012

Response to Deceptive Bloggers about Nerium


Deceptive bloggers are challenging the safety of NeriumAD with false and misleading statements.


Safety of the Product:

To refute these baseless claims, please see the below document for more information on the safety of our product.  The safety of NeriumAD has been verified by renowned physicians and scientists. Watch for an upcoming release of interviews with these accredited professionals.

Why do these bloggers question the safety of NeriumAD?  There are two reasons:  They are uninformed and /or have an ulterior motive for publishing false information.  We do not believe these bloggers are uninformed; rather, they are systematically issuing false statements about NeriumAD and similar beauty products in an attempt to mislead readers and drive internet traffic to their skin care products.  NeriumAD is one of several products that have been targeted by these bloggers.

Many of these bloggers claim credentials that they do not have. For example, the president of one of these blog sites claims to be a licensed physician, but we have proof he is not.  To combat and silence these “experts”, we are in the process of gathering evidence to submit to the appropriate state medical boards and Attorney General offices.

Leaders, these blogger attacks serve as a reminder of the importance to verify sources making claims on the internet.  Many of these bloggers fabricate or embellish their credentials and provide misinformation on reputable products for their selfish gain.

We appreciate your help in disseminating the correct safety information about NeriumAD to those who have any questions regarding this subject. We will be releasing more information on this subject soon. A pdf version of this communication will be available for you in the document library of your Online Business Center.

We want to stress that protecting our Brand Partners’ integrity is of utmost importance.

Safety Statement from Nerium Skincare
Nerium SkinCare is dedicated to offering skin care solutions that are safe and based on proven science and actual customer success. The primary goal of the company is the development of unique, safe and effective products that are of the highest quality.

Product Safety Testing:

Safety for Nerium SkinCare products start at the company owned Farming Operations. Fields of Nerium oleander plants (a specific variety) are harvested for the raw plant material utilized in our extraction processing. Utilizing strict biomedical field protocols, the farm provides a dedicated and renewable biomass resource reserved exclusively for biotechnology research, product development, and product production. Analytical testing for safety begins at the field level and is performed by independent third parties. Prior to harvest, analytical testing is performed for identification of specific components of the plant and includes testing for levels of metals and pesticides. After the processing/milling of the raw plant material, the Nerium oleander powder biomass is again tested for specific components and microbiology for aerobic count, etc.

GMP manufacturing provides for testing at every phase of product production. The first phase is the Nerium oleander biomass extraction process that provides the Nerium extract ingredient (NAE-8™) which is then tested for specific plant components, micro, etc. as are all additional ingredients. Testing continues after each process, cream manufacturing, filling/packaging, and all the way to the finished product. Upon completion of the manufacturing process, the finished product is once again tested by an additional third party laboratory for specific Nerium oleander components to ensure safety and quality. In addition, batch samples for each production run are retained for testing at various intervals thereafter.

NeriumAD Safety:

With the primary goal of product safety and quality, Nerium SkinCare has taken great care with respect to the safety of their lead product NeriumAD. With the identification of potential topical applications from research on Nerium oleander extracts, Nerium SkinCare contracted with ST&T Research (Science, Technology, and Toxicology) to provide additional research and a series of clinical trials for safety and efficacy over a 5 year period (2008-2012). In each clinical trial safety parameters were set to assess efficacy and evidence of any adverse reactions which included detailed studies of the product’s key ingredients to determine if there was absorption through the skin barrier into the blood. The study protocols compared baseline and weekly testing of study participants utilizing an extremely powerful LC/MS/MS analytical instrumentation (capable of detecting nano-gram sized concentrations) which generated data that confirmed no detectable levels of the of the ingredients were found in the blood.  The ST&T clinical data from the NeriumAD clinical trial confirmed safety.

As confirmation of ST&T data and results, Nerium SkinCare provided these findings along with other data from the world literature to an independent group of MD and PhD Pharmacologist/Toxicologist to review the literature and all clinical data on Nerium oleander and NeriumAD.  The determination of this group is that NeriumAD is safe.

In addition Nerium SkinCare has presented research, clinical and safety results at various meetings. As an example, a panel discussion of NeriumAD was presented at the Annual Meeting of the North American Congress of Clinical Toxicology … (NeriumAD Safety Panel Presentation/Discussion). A group of five scientists included MD’s, Pediatrician toxicologists/pharmacologists and PhD’s, who are professors of Pharmacology and Toxicology and directors of US poison control centers, one of the five is a MD, Ph.D. pharmacologist/toxicologist and a former Medical Officer for the Food and Drug Administration. It’s needless to say, a very distinguished panel with the ability and credibility to speak to safety; and recognized members of the North American Congress of Clinical Toxicology. The presentation/discussion included the review of Dr. Newman’s research and ST&T clinical data, a review of the data base of the American Association of Poison Control Centers as it relates to Nerium oleander, data from the world literature, and a discussion regarding some of the myths about Nerium oleander which have sprung up in folklore. Also discussed was the potential toxicity of NeriumAD as it relates to accidental ingestion by children, and a relative risk comparison to other safe products that are also known to contain natural occurring toxic compounds. The conclusion of this panel is that NeriumAD is safe. To share a comment on NeriumAD as it relates to children, the Pediatric MD, Pharmacologist/Toxicologist panelist commented that if a 1 year old child ate the full contents of 400 bottles of NeriumAD, the child would still only reach a non-toxic dose of NeriumAD.

Quality Statement:

As a commitment to quality, Nerium SkinCare will not compromise on the quality of our products. The quality of Nerium’s products is a direct result of the investment made into its people, the scientific research, new technology development, natural farming methods, biomass processing, cGMP production facilities, product safety testing, and independent verification.