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Warning Letter Review: What went wrong & how to avoid

This warning letter is a great teaching case. Learning how to read enforcement trends can protect your company.



Here are some of the things I will review. See my comments in red below.

*Reasons to clean up old social media posts *Hashtags are claims *Don't market to kids *Don't use the words Coronavirus/COVID (see video here) *Blogs count as claims *Enforcement trends: videos and socials cited in most letters *Implying symptomatic relief for COVID symptoms is bad



From Warning Letter:
Your blog post titled,BACK TO SCHOOL: NEW KIDS AND TEEN IMMUNE PAKS” at https://www.hotzevitamins.com/Back-to-School-NEW-Kids-and-Teen-Immune-Paks_b_16.html displays images of your products “Dr. Hotze’s Kids Immune Pak,” “Dr. Hotze’s Teen Immune Pak,” and “Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics” and includes the following claims:
• “The time to start boosting their immune system is now . . . because of the coronavirus . . . Another way to help boost their immune system is with quality vitamins, minerals and probiotics. Take a look at the many health benefits of these supplements:

Asa's Commentary on above

  • Blogs are claims when there is a commercial gain or material connection. This is a great example of a well-intentioned social media manager creating content that is designed to be helpful but is full of claims. See my post here.

  • Children fall into the "vulnerable population" area. Use caution when marketing to them.

  • Use of "buzzword" Coronavirus. This carries a risk factor of 5 of 5 (Asa's rating system) Here's my webinar on this.

  • Implying the product will be useful for coronavirus symptoms. In the eyes of the FDA/FTC, this may suggest the consumer doesn't need to take preventative action (e.g. masks, hand washing)





 “Vitamin B6 has been implicated in the regulation of immune responses that are associated with a wide range of diseases, including inflammation ….

Asa's Commentary on above

  • FDA enforcement trends show inflammation showing up more frequently. This carries a risk factor of 3.5 out of 5 (Asa's rating system)

  • Use of "buzzword" disease. Remember the FDA disclaimer "Not intended to treat, diagnose, prevent disease". This is at the root of all claims-compliance questions.




 “Research demonstrates that probiotics are safe and effective for fighting the common cold and influenza-like respiratory infections….

Asa's Commentary on above

  • Use of "buzzwords" cold and influenza. This carries a risk factor of 4 - 4.5 out of 5 (Asa's rating system)


 
On your Hotze HWC website, www.hotzehwc.com, which directs consumers to your website www.hotzevitamins.com to purchase your products: 

Asa's Commentary on above

  • This is the material connection. If not link or call-to-action to purchase products, this would be lower risk.



From your May 26, 2020, blog post titled, “Dr. Erika Schwartz on The Immune System and Coronavirus” at https://www.hotzehwc.com/2020/05/dr-erika-schwartz-on-the-immune-system-and-coronavirus/, which provides a transcript of Dr. Steven Hotze’s interview with Dr. Erika Schwartz and attributes the following statements to Dr. Hotze:
• “Dr. Hotze: . . . I was on Fox News on March the 15th, Sunday afternoon, on the coronavirus pandemic report. . . And I talked about the importance of vitamin A, B, C, D and Z with the probiotic, and I made my case and said, ‘Build up your immune system that’s what you need to do. If you have a healthy immune system, you’re not going to have to worry about this virus or that virus or this bacterial infection, you’re going to be healthy. And that’s what you can do and you need to do that now through . . . the vitamins you take . . .I mean, the lady looked at me and she goes, ‘We don’t really believe vitamins and all those things can help you with the coronavirus.’ Well of course it can.

Asa's Commentary on above

  • Blogs are claims when there is a commercial gain or material connection.

  • Old social media posts. I strongly suggest cleaning up old non-compliant social media posts as they can only cause problems. Some warning letters have referenced two-year-old posts! I'm sure our opinions on this disease have changed since March 2020 and this post should have been removed. Read about this in my Operation CBDeceit blog.

  • The blog references a transcript from an external site. When the company re-posted they substantiated the claims made, which were quite egregious. Again, this is for the benefit of commercial gain. The connection between an outside interview being substantiated by the company shows the FDA/FTC being clever to piece this together, Here's a webinar where I review this.



In a May 27, 2020, post, you link to your May 2020 newsletter titled, “The Coronavirus Fraud: Power, Control and Money” at www.hotzehwc.com/wp-content/uploads/2015/02/Hotze-Healthy-Living-Newsletter-May-2020-1.pdf, which includes the following claims:
• “COVID-19 is not the lethal threat it’s made out to be . . . The most important thing you can do is strengthen your immune system . . . Here are my recommendations for strengthening your immune system . . .

Asa's Commentary on above

  • Use of "buzzword" Coronavirus.

  • The company implies Coronavirus is not a lethal threat, which goes against CDC guidelines and may suggest the consumer doesn't need to take preventative action (e.g. masks, hand washing). The company then implies purchasing their product protects from Coronavirus.

  • This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post.



“Order Dr. Hotze's Immune Pak with vitamins A, B, C, D, and Zinc – www.hotzevitamins.com/dr-hotze-s-immune-pak.html
#covid19 #coronavirus #pandemic . . . #fightdisease . . .

Asa's Commentary on above

  • Hashtags are claims. See my post here.


Your post hyperlinks to a YouTube video you posted on March 10, 2020, in which Dr. Hotze states: “The key to preventing yourself from getting the flu or the coronavirus is having a good healthy immune system. Healthy people don’t get disease. So think about the A, B, C, D and Zs of strengthening your immune system. Vitamin A, B complex, Vitamin C, Vitamin D, and Zinc. In order to help you strengthen your immune system, I’ve devised Dr. Hotze Immune Pak. . .[video entitled “Boost Your Immune System – Hotze Vitamins Immune Pak” at 0:040:34, https://youtu.be/0gzA3REXw1s]

Asa's Commentary on above

  • Enforcement trends: Claims made in videos (and infograhics) are showing up on more warning letters these days.

  • Implying that Coronavirus will not affect healthy people may reduce the likelihood of preventative measures (handwashing, social distancing etc..). This is very high risk.

  • -Use of "buzzwords" Coronavirus

  • -Substantiating the video claims by hyperlinking it (material connection).



On your social media websites http://www.twitter.com/hotzehealth/ and www.twitter.com/HotzeVitamins/:
In an April 15, 2020, post:
12 Tips to Boost Your Immune System – hotzehwc.com/2020/04/10-way… #covid19 #coronavirus . . . #fightdisease . . .

Asa's Commentary on above

  • Social media claims are cited in nearly every recent warning letter.

  • Hashtags are the quickest way to attract attention to claims being made.

  • Old social media posts should be cleaned up. I mean who looks at a Twitter post from 6 months ago other than the FDA/FTC?


This post links to your April 7, 2020, blog post titled,10 Ways to Boost Your Immune System” at https://www.hotzehwc.com/2020/04/10-ways-to-boost-your-immune-system/, which includes the following claims:
o A graphic on the webpage states, “Protect Yourself with DR. HOTZES IMMUNE PAK . . . providing the extra protection needed to help ward off infections. . .

Asa's Commentary on above

  • Infographics are showing up in more letters. The morale is, any marketing must be truthful and not misleading.


That was a fun teaching case. Any questions or comments please let me know.

Warning letters are a big deal. I review Reasons to Avoid Warning Letters here.


For a free consultation regarding your compliant marketing or quality system review contact me here.


Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

 
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Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.