Thursday, October 1, 2015

tru Weight & EnergyTM Warning Letter FDA


TruVision Health LLC 9/21/15


Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740 


WARNING LETTER
SEPT 21, 2015 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Derek Bailey, Founding Partner
Shawn Gibson, Founding Partner
Travis Martin, Founding Partner
TruVision Health LLC
12244 S Business Park Drive
Ste. 115
Draper, UT 84020-6522 US
Re: 461315 
Dear Mr. Bailey, Mr. Gibson, Mr. Martin and:
This letter concerns your product tru Weight & EnergyTM, which is labeled and/or offered for sale as a dietary supplement. The Supplement Facts panel on your product label appears to declare AMP as a dietary ingredient. This ingredient is also called, among other names, 1,3-Dimethylbutylamine, DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.  In addition, the Supplement Facts panel on your product label appears to declare Bitter Orange Extract (synephrine 30%) as a dietary ingredient. 
The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(ff)). Given that you appear to declare DMBA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMBA is a “dietary ingredient” under section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)). Assuming that DMBA is a “dietary ingredient,” it would also be a “new dietary ingredient” for which a notification is required under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6.
Under section 413 of the Act (21 U.S.C. 350b), a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act (21 U.S.C. 342(f)) unless it meets one of two requirements:
1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
DMBA
To the best of FDA’s knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, DMBA is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under sections 301(a) and (v) of the Act (21 U.S.C. 331(a) and (v)). To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient. 
It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced DMBA is not commonly used as human food or drink. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of the preceding categories. Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.
Bitter Orange Extract (synephrine 30%)
Bitter orange (C. aurantium) is a dietary ingredient under sections 201(ff)(1)(C) and 201(ff)(1)(E) of the Act and has a history of use by man intended to supplement the diet. However, the levels of synephrine in Bitter Orange Extract (synephrine 30%) have been modified from naturally occurring levels. The natural p-synephrine content in dried bitter orange ranges from 0.012%-0.25%[1] and the content of p-synephrine in concentrated extracts or commercial products are standardized to 4-6%[2],[3],[4]
To the best of FDA’s knowledge, there is no information demonstrating that Bitter Orange Extract (synephrine 30%) was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, Bitter Orange Extract (synephrine 30%) is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%), when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, your tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%) will reasonably be expected to be safe when used as a dietary ingredient. In fact, there is evidence from short term human and animal studies suggesting that the consumption of products containing a high dosage of bitter orange extract and synephrine could lead to a significant increase in systolic blood pressure, diastolic blood pressure, and heart rate.  Similarly, products containing Bitter Orange Extract with high doses of p-synephrine and caffeine, also an ingredient in your product may be of potential safety concern. The combination of these substances is likely to enhance their potential cardiovascular effects and could contribute to a significant increase in heart rate and blood pressure[5].
We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your tru Weight & EnergyTM product or other dietary supplement products marketed by your firm, including any that contain DMBA and/or Bitter Orange Extract (synephrine 30%). We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
Failure to immediately cease distribution of your tru Weight & EnergyTM product and any other products you market that contain DMBA and/or Bitter Orange Extract (synephrine 30%) could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Mr. Rob Genzel, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Genzel atrob.genzel@fda.hhs.gov.
Sincerely,
/S/                                                                                               
William A. Correll
Director
Office of Compliance
Center for Food Safety
  and Applied Nutrition


[1] Rossato, L. G.; Costa, V. M.; Limberger, R. P.; Bastos, M. d. L.; Remião, F., Synephrine: From trace concentrations to massive consumption in weight-loss. Food and Chemical Toxicology 2011, 49, (1), 8-16.
[2] Kubo, K.; Kiyose, C.; Ogino, S.; Saito, M., Suppressive Effect of <i>Citrus aurantium</i> against Body Fat Accumulation and Its Safety. Journal of Clinical Biochemistry and Nutrition 2005, 36, (1), 11-17.
[3] Nguyen, D. T.; Bui, L. T.; Ambrose, P. J., Response of CEDIA amphetamines assay after a single dose of bitter orange. Ther Drug Monit 2006, 28, (2), 252-4.
[4] Penzak, S. R.; Jann, M. W.; Cold, J. A.; Hon, Y. Y.; Desai, H. D.; Gurley, B. J., Seville (sour) Orange Juice: Synephrine Content and Cardiovascular Effects in Normotensive Adults. The Journal of Clinical Pharmacology2001, 41, (10), 1059-1063.
[5] Health assessment of sports and weight loss products containing synephrine and caffeine. www.bfr.bund.de

Friday, September 25, 2015

Bye - Bye Vemma




As with all good marketing strategies within the MLM industry, truth never be told.

What happened?

 The FTC has stated that Vemma has violated Section 5(a) of the FTC Act by:

a) Operating an illegal pyramid scheme;

b) Falsely representing that members of the Vemma program ("Affiliates") are likely to earn substantial income;

c) Representing that individuals have earned substantial income from participation in the V emma program and that consumers who become Vemma Affiliates have the ability to earn substantial income, while failing to disclose, or disclose adequately, that Vemma's structure ensures that most consumers who become Vemma Affiliates will not earn substantial income; and

d) Providing the means and instrumentalities for the commission of deceptive acts and practices by furnishing Vemma Affiliates with promotional materials to be used in recruiting new participants that contain false and misleading representations. 

Friday, August 28, 2015

Derrick Raynes, Sherman Unkefer, TruVision Health or ViSi




Named in the 2014 complaint were:

Sherman Unkefer, XanGo LLC, Mango Trust, Mango Ltd., Laundy Unkefer, Grant Teeple, Todd Hall, Teeple Hall LLP, Theresa Lee, Adrian Taylor, Jean-Luc Merat, Jerry Whitmore, Richard and Karol O'Brien, a foreign fiduciary company, Derrick Raynes, Raynes' wife, and Alexandria Monique Unkefer Raynes.

Is Derrick Raynes flogging TruVision Health products now?
Does ViSi have Sherman`s hands all over it.


Vemma is an illegal pyramid scheme, allegedly

Sourced from: the FTC:

At the Federal Trade Commission’s request, a federal court has temporarily halted an alleged pyramid scheme, Vemma Nutrition Company, that lures college students and other young adults with the prospect of getting rich without having a traditional 9-to-5 job. The FTC seeks to stop the operation, which earned more than $200 million annually in 2013 and 2014 and has affected consumers throughout the United States and in more than 50 other countries, from continuing as an unlawful pyramid.
Rather than focusing on selling products, Vemma uses false promises of high income potential to convince consumers to pay money to join their organization,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “We are also alleging that Vemma is an illegal pyramid scheme.”
Vemma is a multilevel marketing company that claims to use its members, called “affiliates,” to promote its health and wellness drinks. According to the FTC’s complaint, the defendants claim affiliates can earn substantial income by enrolling others either as affiliates or as customers, but Vemma focuses on recruitment rather than retail sales of its products to generate this income. The vast majority of participants make no money, and most of them lose money.
According to the FTC’s complaint, the defendants’ websites, social media, and marketing materials show seemingly prosperous young people with luxury cars, jets, and yachts, and falsely claim that Vemma affiliates can earn substantial incomes – as much as $50,000 per week. The defendants allegedly claim that affiliates’ earning potential is limited only by their own efforts and that Vemma provides young adults an opportunity to bypass college and student loan debt. Vemma urges consumers to make an initial investment of $500-$600 for an “Affiliate Pack” of products and business tools, buy $150 in Vemma products each month to remain eligible for bonuses, and enroll others to do the same.
Consumer losses are inevitable because Vemma is an illegal pyramid scheme that rewards affiliates for recruiting participants rather than for selling products, the FTC alleges. The defendants provide affiliates little guidance for selling products, but instead teach them to give away products as samples when recruiting new participants. Vemma offers no meaningful discounts or incentives to encourage retail sales, according to the complaint.
In addition to allegedly running an illegal pyramid scheme, the defendants are charged with making false earnings claims, failing to disclose that Vemma’s structure ensures that most people who join will not earn substantial income, and furnishing affiliates with false and misleading materials to recruit others.
The defendants are Vemma Nutrition Company, Vemma International Holdings Inc., Tom Alkazin, and Benson K. Boreyko, who is under a 1999 court order after settling with the FTC for his involvement with New Vision International Inc.,  a multilevel marketing company that sold nutritional supplements. The complaint names Bethany Alkazin as a relief defendant who profited from the scheme. On August 21, 2015, the court halted the deceptive practices, froze the defendants’ assets, and appointed a temporary receiver over the business pending a trial.
The Commission vote authorizing the staff to file the complaint for permanent injunction was 5-0. The order was entered by the U.S. District Court for the District of Arizona on August 21, 2015.
The FTC appreciates the assistance of the Attorney General Offices of Arizona, South Carolina, and Michigan, the Tempe Police Department, and the nonprofit organization Truth in Advertising in bringing this case.
To learn more about multilevel marketing, read Multilevel Marketing and Business Opportunity Scams.
NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The case will be decided by the court.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook(link is external), follow us on Twitter(link is external), and subscribe to press releases for the latest FTC news and resources.


I'm sure that many are happy that the Federal Trade Commission shut Vemma down, and that this paves the way for other shut downs.. Plexus Worldwide .. .perhaps could be next!

Wednesday, August 5, 2015

Good Health Manufacturing

Good Health Manufacturing


Formerly called: GHC ASSOCIATES, INC.

filed an annual report in 2003 listing:
Scott W. Christensen - president
Dennis Harris - vice president
and 
Ronald General - treasurer


Scott Christensen left and a few years later in 2013, 
Deni Lynn General, daughter of Ronald General, was added to the shareholder list:


What irks me is this misleading info, found on their website:



``Deni General - CEO and Founder

With her dedicated work ethic and “hands on” management style, Deni has formed a well - esteemed and highly specialized management team. She understands that good people are the backbone to any successful operation. She is passionate about the Health and Nutrition Industry and knows that quality and customer service, are imperative in today’s market. ``

Hello.. her personal bio found on another site states this; 

``Specialties: interior design & concept development, customer relations, customer satisfaction, materials management, meeting facilitation, bookkeeping, budgeting, pricing, sales, trade shows, vendor relations. Computer skills include QuickBooks, microsoft excel, microsoft windows, microsoft windows, microsoft word.``

She has her name on daddy`s company.

Friday, June 5, 2015

thepinkdrinkscam: Plexus Mega X

thepinkdrinkscam: Plexus Mega X: Plexus Worldwide released another new product at their convention in Arizona. "Plexus Mega X" ‪#‎ oneplexus‬  showed their ...

Monday, May 25, 2015

Plexus Worldwide faces Legal Action

Plexus Worldwide is facing Legal Action, not by the ambassadors it has screwed over, or by the customers it has done wrong, but by past Plexus Worldwide "President", Alfred Pettersen!

Pettersen filed paperwork in the Maricopa court system on May 15, 2015.

Canadian born, Alfred John Pettersen, former Enrich distributor under Ken Pontious (Tarl Robinson's "step" dad)  and "TEAM Paragon",  and "co-founder" of Plexus Worldwide, has been absent from Plexus since his "leave" in 2014 where a company memo was sent claiming him to be taking time off to spend with his new wife. (Now soon to be ex-wife).

""As a stockholder in the company, you can be sure that Plexus will never be far from my mind." - Alfred Pettersen, Plexus Int'l President "" (dated June 2014)

In fact, just the opposite is true. 


During this "leave" Alfred Pettersen teamed up with Dennis Harris. Harris was dubbed the Plexus Medical Director. (his departure from Plexus Worldwide was very sudden and quiet). Harris is well known for the "Snore Formula".

Together with Mark Derr and Ronald General, they formed a company: GHPD LLP.  GHPD LLP has not made public any business ventures as of yet.

Alfred Pettersen has filed paperwork against Tarl Robinson, current Plexus CEO, shown below in the white shirt, beside his cousin and "Senior Marketing/Communications Manager" Chris Pike. Tarl Robinson was recently voted #1 in a Direct Selling "compliant" poll, not something to call mom, Shirley Pontious, and brag about!



Named in the Civil Court Case are Tarl Robinson, and the 5 differently named Plexus companies:


  1. Plexus Worldwide Inc 
  2. Plexus Worldwide LLC 
  3. Plexus Worldwide LLP
  4. Plexus Holdings Inc 
  5. Plexus Holdco LLP


Left to Right: Alec Clark, Tarl Robinson, Alfred Pettersen



How long has this bad blood existed between Tarl and Alfred? What role does Alec Clark have in this? Those 3 smiles are just saying "money, money and more money"

Not many have speculated about what is really going on here. Is this a Corporate take-down and what is his motivation behind it?   Is this part of the conspiracy to destroy Plexus Worldwide? Does Alfred Pettersen have his hand in the TruVision business?  or, perhaps as Plexus Slim Dave Brown has once said, "smoke and mirrors", is huge in this industry. Are these 3 wise men up to something else? After all, the FDA is still investigating the company, I'm sure that the FTC and other legal entities have been or will be involved in this investigation.


At this point in time all that is known is that papers have been filed. The content of those legal documents have not been publicly released.


Thursday, April 16, 2015

U.S. Marshals have seized unapproved prescription drug products valued at over $1,500,000

At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida, U.S. Marshals have seized unapproved prescription drug products valued at over $1,500,000 from Stratus Pharmaceuticals, Inc., of Miami, Florida. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.
The seized products include:
  • a solution used to treat excessive sweating;
  • an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea and seborrhea;
  • a topical ointment used to treat wounds;
  • a topical cream and gel to treat psoriasis, eczema and other skin conditions; and
  • analgesic ear drops used to treat ear pain.
These products have not been proven safe and effective for their intended uses. The FDA recommends that consumers who believe they have drugs marketed by Stratus Pharmaceuticals consult a health care professional or pharmacist about discontinuing the use of these products and identifying an alternative treatment option.
“Companies that market unapproved drugs are placing consumers at risk because the products may not be safe, effective or made using quality manufacturing practices,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to protecting consumers and will continue to take actions against companies that do not meet these standards.”
The U.S. Attorney’s Office filed a complaint on behalf of the FDA in the U.S. District Court for the Southern District of Florida, alleging that the products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.  
The complaint follows an FDA inspection conducted in November and December 2014 that revealed the company was marketing these drug products without FDA-approved drug applications. The new drug approval process plays an essential role in ensuring all drugs are safe and effective for their intended uses. Unapproved drugs have not been shown to be safe and effective, may be of uncertain quality and do not have FDA-approved labeling. As a result, these drugs may pose risks to patients. 
The seizure of these products is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which, among its other provisions, provides notice that any product that is being marketed illegally and the persons responsible for causing the illegal marketing of the product are subject to FDA enforcement action at any time.  
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This has been reprinted from original source