NAD Finds Certain Claims for Dr. Ho’s Circulation Promoter Supported; Recommends Modification or Discontinuation of Others
For Immediate Release
Contact: Abby Hills, Director of Communications, BBB National Programs
703.247.9330 / email@example.com
New York, NY – September 15, 2020 – The National Advertising Division (NAD) of BBB National Programs determined that VGH Solutions Inc. supported certain claims for Dr. Ho’s Circulation Promoter (“Circulation Promoter”) medical device consistent with the FDA’s approved indications of use and claims that the device is “safe.” However, NAD recommended that the advertiser discontinue establishment claims that the Circulation Promoter is “clinically tested” to improve circulation, relax muscles, and relieve pain, as well as a variety of health-related claims. In addition, NAD recommended that the advertiser modify other challenged claims to more accurately reflect the FDA’s approved indications of use.
The challenged claims were brought to NAD by Actegy Health, Inc., manufacturer of competing products.
The following are representative of the challenged claims, which were made on the advertiser’s website, social media, and in various long-form advertisements, such as an infomercial featuring a host, a company representative, Dr. Michael Ho, a studio audience, and consumer and expert testimonials.
- “Clinically Tested - Improves Circulation, Relax Muscles, Relieve Pain.”
- “No Risk”
The Circulation Promoter can be used for:
- “Neuropathy/loss of sensation/suitable for damaged feet (ulcers/amputation)/device wakes the nerve up/restores the sensation”
- “Diabetes and other health conditions”
- “Bad circulation” [chronic]
- “after hip or knee replacements”
- “Calf/foot injuries; bunions”
- “Sleep improvement”
- “Immediate Pain Relief/back pain/no pain/pain relief guaranteed/in 20 minutes”
The Circulation Promoter can:
- Provide healthier tissue and decreased pain
- “activate the arteries, vein and lymphatic system”
- “reduce swelling and water retention”
- Enable the user to “Walk better; stand better; everything is working better; relief from damage to your spine and joints”
- Help you to “Live a more active life”
The Circulation Promoter:
- Is “safe” and without side effects
- Will cure various conditions (“Stop wasting time with endless appointments”)
- Will cure or significantly improve debilitating conditions (“Live a more active life”)
- Will restore users from chronic debilitating conditions (“You don’t need anybody; you get your independence back”)
- Dr. Ho’s name implies that he is a medical expert with respect to circulation/cardiovascular disease. Three other doctors provide expert opinions and do not declare they are chiropractors.
In support of its claims that the Circulation Promoter is “clinically tested” to improve circulation, relax muscles, and relieve pain, the advertiser relied on a 2005 study conducted by Dr. McGill on the “High-Intensity Modulating TENS” device. NAD evaluated the methodology of this study and determined that it does not constitute competent and reliable evidence to support a “clinically tested” claim. Therefore, NAD recommended that the advertiser discontinue the claims that the Circulation Promoter is “Clinically Tested. Improves Circulation” and “Clinically Tested - Improves Circulation, Relax Muscles, Relieve Pain.”
NAD also recommended that the advertiser discontinue the following health-related challenged claims:
- Circulation and oxygenation claims
- Unqualified pain elimination and relief claims, as well as claims communicating that the device delivers immediate pain relief and 20-minute pain relief
- Neuropathy/loss of sensation claims
- Provide healthier tissue and decreased pain
- Arteries, veins and lymphatic system claims
- Swelling and water retention claims
- The on-screen super “use after hip or knee replacements”
- The claim “it can treat conditions like arthritis and bunions”
- The claim it can enable the user to “walk better; stand better; everything is working better; relief from damage to your spine and joints”
- The claims “stop wasting time with endless appointments” and “live a more active life”
NAD noted that nothing in its decision prevents the advertiser from making claims approved in the FDA’s 510(k) clearance. NAD also recommended modification of the following challenged claims, so they are more narrowly tailored to reflect the FDA’s approved indications of use:
- The claim “anyone with painful foot conditions – first thing in the morning want to use this. Bunions, arthritis in the feet – you want to use this”
- The claim that the product treats “calf injuries” and “foot injuries”
- Sleep improvement claims
- NAD also recommended that the advertiser avoid communicating the message that the product provides sufficient pain relief to allow for meaningful sleep improvements
NAD determined that the claim “you don’t need anybody; you get your independence back. You don’t need your friends and family to help you,” in context, conveys the message that the device can be used at home and administered by the individual user (without assistance from a doctor) and is not misleading.
NAD determined that to the extent that the advertiser did not provide a reasonable basis for certain challenged claims, any such claims made by the expert endorsers must also be discontinued. However, NAD found that the chiropractors’ endorsements of the Circulation Promoter with regard to pain relief are not misleading. The advertiser presented evidence sufficient for NAD to conclude that chiropractic care is a well-accepted method to address back pain, and pain in the arms, leg, and neck and that chiropractors are experts in the relevant field of pain management.
With regard to the claim of “no risk,” which was made in connection with a 90-day money back guarantee, NAD recommended that the advertiser discontinue the “no risk” claim and modify its disclosure to make it abundantly clear that customers must pay for shipping and will receive a refund of the purchase price only.
NAD determined that the advertiser provided a reasonable basis for its claims that the device is “safe.” NAD also determined that Dr. Tabrizi’s statement that “this unit is very safe,” is not likely to convey the misleading message that there are no potential side effects, but simply that the Circulation Promoter is safe to use.
Finally, during the proceeding, the advertiser voluntarily and permanently discontinued the following claims, so NAD did not review these claims on their merits:
- Website Testimonial “I had really, really bad circulation in my legs, swollen, burning and there was uncomfort [sic] for working, for walking.”
- Dr-Ho: “. . . it can get seriously infected. You need to use this because if you cut your feet and it gets infected you can lose a toe, lose a foot, a leg and even your life. . ..”
- Website: Diabetic Nerve Damage – Testimonial “. . . I suffer nerve damage in my feet and some in my legs.”
In its advertiser’s statement, VGH Solutions stated that it “will take into consideration the NAD decision and modify its marketing claims to comply with the decision.”
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About the National Advertising Division: The National Advertising Division (NAD), a division of BBB National Programs, provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
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