Opioid Cessation Products: FTC, FDA Warn Companies about Marketing & Selling

FTC, SAMHSA also issue fact sheet on how to get the right help for addiction and withdrawal

The Federal Trade Commission and the U.S. Food and Drug Administration (FDA)  posted warning letters to the marketers and distributors of 11 opioid cessation products for illegally marketing products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said Acting FTC Chairman Maureen K. Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments. We will continue to work together with the FDA to address this important issue.”

Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.

Also today, the FTC, in coordination with SAMHSA of the U.S. Department of Health and Human Services (HHS), issued a fact sheet to help consumers get real help for opioid addiction or withdrawal, while avoiding products that promise but do not deliver help. The fact sheet has tips that consumers and health practitioners alike can share with those considering help for opioid addiction or withdrawal. Patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to SAMHSA.

The FDA and FTC issued joint warning letters to 11 companies for their products: Opiate Freedom Center (Opiate Freedom 5-Pack); U4Life, LLC (Mitadone); CalmSupport, LLC (CalmSupport); TaperAid (TaperAid & TaperAid Complete); Medicus Holistic Alternatives, LLC (Natracet); NutraCore Health Products, LLC (Opiate Detox Pro); Healthy Healing, LLC (Withdrawal Support); Soothedrawal, Inc. (Soothedrawal); Choice Detox Center, Inc. (Nofeel); GUNA, Inc. (GUNA-ADDICT 1); and King Bio, Inc. (AddictaPlex).

The FTC sent four additional warning letters to other marketers of opioid cessation products.

All of the companies use online platforms to make unproven claims about their products’ ability to cure, treat, or prevent a disease. Examples of claims made include:

  • “#1 Selling Opiate Withdrawal Brand”
  • “Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms.”
  • “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”
  • “Break the pain killer habit.”
  • “Relieve Your Symptoms…addiction, withdrawal, cravings.”

The FTC and FDA have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address each agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.

Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form.The completed form can be submitted online or via fax to 800-FDA-0178.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.

FDA Needs Public to Report Adverse Events Related to Homeopathic Products

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

For more information click here.

TINA, Truth in Advertising.org, Lists 7 Marketers to Beware: Goop, Kardashians & More

Photo: Goop Magazine, Issue 2, Courtesy shop.goop.com.

7 MARKETERS, INFLUENCERS THAT GET COAL IN THEIR 2017 HOLIDAY STOCKINGS

As we ring in the New Year, the folks at TINA.org (TINA.org exists to out deceptive marketing and promote honest advertising) like to wring out companies and/or people whose advertising didn’t meet truth in advertising standards. This year’s list of marketers that should get coal — notice they didn’t say clean coal — in their holiday stockings runs the gamut from a women’s lingerie website that essentially stripped consumers of their ability to cancel memberships to a supplement that falsely claims that it’s “clinically shown” to improve memory. Here’s who is on TINA.org’s 2017 list (in alphabetical order):

+ 1. Adore Me

Facing allegations that it failed to treat its VIP members very importantly, New York-based women’s lingerie website Adore Me agreed to pay more than $1.3 million to settle FTC charges that it deceived shoppers who enrolled in what turned out to be a thorny negative-option offer. The FTC action followed a TINA.org investigation and complaint to the agency and laid bare how the lingerie company put up barriers to canceling VIP memberships and broke promises that store credits could be used “any time.”

+ 2. DealDash

Unless you swore off TV in 2017 chances are you’ve seen commercials for DealDash, a penny auction site that spends a prodigious amount on advertising (more than $50 million in 2016). And if you’ve seen the ads, you’re familiar with DealDash’s slogan — “the fair and honest bidding site.” But what you may not know is that advertised bargains on electronics, appliances, and other products don’t include the cost of bids. In fact, a TINA.org investigation found most consumers can expect to lose money bidding on items on DealDash. Moreover, the company’s pay-to-bid scheme constitutes a form of illegal gambling, as TINA.org noted in complaint letters to six state attorneys general and the FTC.

+ 3. Goop

TINA.org had a very Goop-y summer. Let us explain: In June, Goop, Gwyneth Paltrow’s “lifestyle brand,” hosted its first-ever wellness summit in, where else, LA. TINA.org was there, undercover, and along with some swag took home a number of illegal health claims for products Goop promotes. These would become part of a larger sampling of claims to treat everything from depression to infertility that we packaged and shipped to regulators in California to investigate further.

+ 4. The Kardashians

Either they don’t “get it” or the Kardashian/Jenner sisters are purposely breaking the law for the benefit of the brands that pay them to promote their products on social media and may not want that disclosed. What other reason is there for the world’s foremost social media family to continue to skirt disclosing #ad in paid-for posts? For the second year in a row, TINA.org uncovered a plethora of sponsored posts published by the Kardashian/Jenner sisters that lack proper disclosure in violation of federal endorsement guidelines. And for the second year in a row, we notified the FTC of our findings.

+ 5. LuLaRoe

We could barely keep up with the number of class-action complaints filed against California-based LuLaRoe in 2017. In fact, the pyramid scheme allegations and claims of defective apparel came so fast that, in November, we had to make a chart to help make sense of it all. That was seven months after we published a review of LuLaRoe outlining what consumers should know about the MLM, whose distributors are known for flooding social media with pitches to sell its highly sought after “unicorn” leggings. LuLaRoe has dismissed the allegations and in the face of mounting criticism responded with a lawsuit of its own.

+ 6. Prevagen

The marketers of Prevagen should remember 2017 as the year in which its memory improvement claims were finally given the regulatory scrutiny we at TINA.org think they deserve. Two years after TINA.org called on the FTC to halt Wisconsin-based Quincy Bioscience’s deceptive marketing of Prevagen, the agency, along with the New York State Attorney General, charged the company with making false and unsubstantiated claims that its Prevagen supplement improves memory, provides cognitive benefits, and is “clinically shown” to work.

+ 7. Target

Target may have dodged a bullet (or, more precisely, a hefty fine) when the FTC opted not to further pursue an inquiry into the retailer’s misleading Made in the USA claims, in part because Target assured the agency that it had cleaned up its marketing. But TINA.org picked up right where the FTC left off and found a range of products specified as “Made in the USA” on Target.com despite their packaging indicating that they’re either wholly or partially made in other countries. At which point we called on the FTC to reopen its investigation.

Read more about TINA.org’s legal efforts to fight false and deceptive advertising here.

FDA Needs Public to Report Adverse Events Related to Homeopathic Products

The Sunday Sessions: Documentary Explores Conversion Therapy

A RElIgIOUS YOUNg mAN’S IDENTITY IS CAllED INTO qUESTION WHEN HE vISITS A CONvERSION THERAPIST.

THE SUNDAY SESSIONS is an intimate portrait of one man’s struggle to reconcile his religious conviction and sexual identity. The observational documentary chronicles the turbulent journey of a devoutly Catholic gay man as he attends conversion therapy in hopes of changing his sexual orientation.

Conversion therapy is the controversial, non-scientifically based process which aims to convert an individual’s sexual orientation from homosexual to heterosexual. Although it has been discredited by all major American medical, psychiatric, psychological and professional counseling organizations, some therapists still offer the service for reasons almost exclusively rooted in a conservative religious belief system.

The filmmakers had unfettered access to individual therapy sessions, family sessions, and a collection of weekend camps, and have crafted an emotional and psychological thriller which chronicles two years of Nathan’s journey from acceptance to skepticism, all leading to a profound epiphany.

After a therapy session, as part of his homework assignment, Nathan burns a pile of trash as a symbol of getting rid of his baggage.

Film Type Documentary

Year Completed 2017

Runtime  94 minutes

Director, Producer Richard Yeagley

thesundaysessionsmovie.com

Spirit photography: William Hope Cashed in on Grief

By Gretchen Mullen, Skeptic Review

Spirit photography, or photos claiming to document ghosts of loved ones, became popular during the late 19th and early 20th centuries as hope rose that photography could finally provide scientific proof of the afterlife.

The impetus behind the proliferation of these highly sought after photos was three-fold:

  1. The photographer mastering this technique could get rich quick, often hanging out with some of the upper echelon of society.
  2. Subjects were anxious to believe their dearly departed loved ones were now heavenly spirits. Too often, subjects photographed were in the throes of a recent loss and were easily exploited. Post-war eras were particularly fruitful.
  3. Cameras were viewed as documenting truth; public knowledge about photographic manipulation was limited.

As early as 1869, American William Mumler, spirit photographer to the stars–not the least of whom was Mary Todd Lincoln–was tried for fraud, but was ultimately acquitted because the prosecutor simply couldn’t quite figure out how the photographs were fraudulently made.

    • Mary Todd Lincoln and the ghost of Abraham Lincoln as photographed by William Mumler, ca.1869.

Enter English spirit photographer William Hope (1863-1933) who garnered a prestigious clientele including an enthusiastic endorsement from Sir Arthur Conan Doyle. Below is a mere sampling of spirit photos produced by William Hope courtesy National Science and Media Museum:

 

Despite being labeled a “common cheat” by Scientific American, support for Hope persisted. William Hope was also the subject of a sting operation conducted by “paranormal investigator” Harry Price (Harry Price merits his own story, to be discussed in a separate article coming soon).

Price’s investigation prompted Sir Arthur Conan Doyle to publish The Case for Spirit Photography in 1922 “to show the overpowering weight of evidence which exists as to the reality of Mr. Hope’s most remarkable gift.”

 

FACTITIOUS: Game helps users learn to spot fake news

Real or fake? At a time when the reading public daily grapples with the question of fake news, the American University Game Lab/JOLT has created an accessible, easy-to-play game that helps you sort fake news from real.

The brainchild of former AU JOLT Fellow Maggie Farley, she pitched the concept more than a year ago, before the 2016 presidential campaign brought the challenges of fake news to the spotlight. For purposes of the game, “fake news” is defined as stories fabricated for fun, influence or profit, as well as satire, opinion and spin.

“Fake news is impossible to stop, so we wanted to playfully teach people how to recognize it,” said Farley. “But the game is fun to play in itself.”

The game engine in the next phase should also be available to newsrooms, schools, or groups that want to adapt a version for their own use.

PS: My first crack at the game yielded 93%. Second crack, not so much. I highly recommend you try this game! It’s fun, enlightening and horrifying. I am especially excited to hear it will be available as a teaching tool. My nephew asked me this week if I had read the warning that “people are injecting the AIDS virus into bananas.”–Gretchen Mullen, Editor, Skeptic Review

Edvard Munch

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PLAY FACTITIOUS HERE:

http://factitious.augamestudio.com/

 

Tweets We Love

Reasons to Believe: 2017 film by Ben Fama Jr. Now Free on YouTube

By Gretchen Mullen

UPDATE: Filmmaker Ben Fama has now made the full film available for free on YouTube. See link at the bottom of this article.

Filmmaker Ben Fama Jr. was kind enough to provide us with a private screening of his new film Reasons to Believe. Here’s our take on this exciting project available for general release on September 11, 2017.

Allegory of the Cave

The film begins with a cinematically pleasing vision of Plato’s Allegory of the Cave, where humans are imprisoned in a cave and denied knowledge of the outside world. In the allegory, humans move from darkness to light, from false beliefs to truth and reason.

The Questions

Fama then poses the following questions:

  • How do beliefs shape our reality? Why do we believe?
  • How are we influenced to believe?
  • How do other people affect our thinking?
  • How do our beliefs hold us back?
  • How do we free ourselves from false beliefs?

The Experts

  • MICHAEL SHERMER, Author, The Moral Arc; The Believing Brain
  • PETER BOGHOSSIAN, Author, A Manual for Creating Atheists
  • CALEB LACK, Coauthor, Critical Thinking, Science, and Pseudoscience: Why We Can’t Trust our Brains
  • JENNIFER WHITSON, Author, “The Emotional Roots of Conspiratorial Perceptions, System Justification, and Belief in the Paranormal”
  • CHAD WOODRUFF, Author, Neuroscience of Empathy and Compassion

The Discussion

Fama’s questions are carefully considered by each expert and are addressed through carefully interwoven comments on each topic.

The film takes us through the human brain’s need to understand the world, often through a process in which beliefs come first and evidence comes second. In other words, beliefs are often not evidence-based, but make us feel better, perhaps even superior to others. These sometimes false beliefs are further influenced and reinforced by family, community, education, and the time period in which we live.  While our beliefs often make us who we are, or who we feel we are, they also have the power to divide us into ideological communities.

The discussion expands on the idea that we may be predisposed to accept certain beliefs because they are often confirmed by intense personal experiences. However, we are reminded, that experience does not equal objective truth.

The experts then explain that much of our human propensity for superstitions, magical rituals, and religious beliefs are rooted in the fact that life is random, unpredictable, and downright scary. We seek to avoid anxiety and a feeling that we like control; we seek comfort and meaning; we want to make sense out of chaos; we want to cope with uncertainty. This magical thinking is reinforced by the brain as we seek out patterns, even if these patterns are false and illogical.

So if false beliefs make us feel better, why does it matter? In the long run, false beliefs can lead to problems, the greatest of which is violence. Bad ideas lead can easily lead to bad behavior. Science teaches us that it really does matter what is right and what is wrong. Faulty beliefs lead to real world consequences and must be combatted. We must update our view of the world and weed out bad ideas. We must use data as opposed to anecdotes.

The film ends on an encouraging and positive note. The experts make practical suggestions to embrace reason. Some of the best:

  • Be comfortable with the words, “I don’t know.”
  • Model the behavior of a skeptic.
  • Use the scientific method.
  • Don’t attack beliefs—be polite, be thoughtful, use humor, listen to others and then respond with statements that open a conversation such as “I wonder how that could be true? What do you think?”
  • Study scientifically why religion has been viewed as so beneficial and how we can address that need in other more rational ways.
  • Help others to trust reason and value correct information.
  • Introduce critical thinking in early education. Teach children to recognize that our brains can fool us.
  • Assert that a more thoughtful and examined life has value.
  • Suggest that an alignment with reality will help humans flourish, that science and reason can and will lead to justice, freedom, prosperity and peace.

Reasons to Believe is well-organized and builds nicely from a primer on the brain to the foundations of belief, ending with a lovely, positive message about the future of skepticism and science and practical solutions we can embrace as individuals and as citizens of the world. It is a film you will want to view more than one time to take it all in.

Michael Shermer ties it up nicely at the end of the film: “I think we have a new enlightenment—a science-based enlightenment.”

View the trailer

The filmmakers

BEN FAMA JR: DIRECTOR

Ben Fama Jr. is an award-winning filmmaker, podcaster, and entrepreneur noted for his work on his short film A Virus Called Fear and his documentary Reasons To Believe. He has been featured in Huffington Post and his films have been featured on PBS, Medibiz.tv, and IndieFlix. Ben’s films and talks reflect the social and psychological behavior of humans and their social constructs on society. He is a very outspoken skeptic and atheist, as well as an advocate for mental health. His goal is to challenge the way we think and see the world, as well as what we believe.

He is the owner of Fama Media Productions, LLC. and the host of the podcast Reality Trip with Ben Fama Jr.

MESA FAMA: PRODUCER

Mesa has produced three award winning films with Ben Fama Jr. including two documentaries and a narrative. She holds a degree in psychology as a graduate from Arizona State University. She continues to produce and manage Fama Media Productions and sometimes is a guest host on the podcast Reality Trip with Ben Fama Jr.

Release date: September 11, 2017

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YouTube Channels We Love: Anthony Magnabosco

Anthony Magnabosco is a Street Epistemologist who converses with and interviews random strangers on the street to ask about their beliefs, such as faith, superstitions, and so much more.

Check out his YouTube channel at: 

https://www.youtube.com/user/magnabosco210

According to Magnabosco, “I initiate friendly conversations with people to see how they arrived at their deeply-held beliefs (e.g., Gods, karma, ghosts, politics, etc.), and then ask respectful questions to help them discover if the method(s) used are unreliable so that more reliable methods can be employed to maintain the belief and/or the level of confidence in the belief can be adjusted to be more in line with reality.”

Of particular interest are these playlists:

My Top Ten Talks

Street Epistemology Presentations

Relativism (“It’s true for me.”)

Street Epistemology Tutorials

(20,599 subscribers • 2,096,049 views  Joined Dec 25, 2011)

Skeptics We Love: James Randi

Photo courtesy of http://web.randi.org/about-james-randi.html

James Randi has an international reputation as a magician and escape artist, but today he is best known as the world’s most tireless investigator and demystifier of paranormal and pseudoscientific claims. Randi has pursued “psychic” spoonbenders, exposed the dirty tricks of faith healers, investigated homeopathic water “with a memory,” and generally been a thorn in the sides of those who try to pull the wool over the public’s eyes in the name of the supernatural.

He has received numerous awards and recognitions, including a Fellowship from the John D. and Catherine T. MacArthur Foundation in 1986 for his work in investigating claims of the supernatural, occult, and paranormal powers—in particular his exposures of TV evangelist/healers and of “psychics” such as Uri Geller.

He is the author of numerous books, including The Truth About Uri Geller, The Faith Healers, Flim-Flam!, and An Encyclopedia of Claims, Frauds, and Hoaxes of the Occult and Supernatural. His lectures and television appearances have delighted — and vexed — audiences around the world.

Our Favorite Quotes:

“No amount of belief makes something a fact.”

“There is a distinct difference between having an open mind and having a hole in your head from which your brain leaks out.”

“The New Age? It’s just the old age stuck in a microwave oven for fifteen seconds.”

Website:

http://web.randi.org/