PSA: FDA warns PA prevention "drug" OTC claims

[Mr. Barlow]

Read, share, judge, whatever. 

• FDA enforcement letter to Aralyte/Antera
  
• FDA enforcement letter to Assured Bites, Inc. (Hello, Peanut!)
  

FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies

Posted 21 November 2016
By Zachary Brennan

The US Food and Drug Administration's (FDA) Office of Compliance in Biologics Quality in the Center for Biologics Evaluation and Research (CBER) on Monday released an untitled letter sent to Cambridge, MA-based Antera Therapeutics because it's selling an unapproved biologic intended to prevent a peanut allergy.

According to the letter dated 16 November to Antera CEO Clarence Friedman, a Harvard Business School graduate in 2015 and former senior associate scientist at Pfizer, FDA says the company's website makes unsubstantiated claims about its "all-natural formula that makes giving peanut protein to your child safe and easy."

Among other issues, the site highlights that the product, known as Aralyte, has been manufactured, packaged and stored "to be maximally effective in allergy prevention and with your family's safety in mind."

A three-month supply of Aralyte costs $180.

"The Aralyte daily regiment was crafted to be a precise amount of exposure to the allergen, keeping your baby safe," the website reads.

"Based on these claims, it appears your product is intended to prevent a peanut allergy from developing in children, and therefore appears to be a drug," FDA said, noting the biologic has not been approved by the agency for safety or effectiveness. "Your product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect for the use of this product. Based on this information, we have determined that your actions have violated the FFD&C [Federal Food, Drugs and Cosmetics] Act and PHS [Public Health Service] Act."

Antera has yet to respond to a request for comment. In June, the company raised $1.7 million in seed funding from RA Capital Management.

Separately on Monday, CBER also released an untitled letter to the CEO of Flushing, NY-based Assured Bites, which offers a similar product intended to prevent a peanut allergy that FDA says is an unapproved biologic.

[gvmom]

...... wondering if Aralyte dosages are based on the LEAP study.....

.... also noticing it is about keeping babies safe..... so, do you start earlier than 3-4 months?

[Mr. Barlow]

Excellent point, gvmom.  Reminds me to add some relevant context.  I've been sitting on these warning letters for a while during the new guidelines roll out waiting to see if the companies would be brought into compliance.  Right after the guidelines hit the media, direct marketing spam from Aralyte picked up referencing LEAP front and center in their marketing materials. 

I'm interested in what the regulatory enforcement will or will not do post guidelines wrt registering product as a biologic drug.  Bamba was used and referenced but they do not make such claims themselves of their product. 



Aralyte's email title (copy and paste as is): Introducing Solid Foods | AAP New Guidance

From: Aralyte <info@anteratherapeutics.com>

Hi ‍!

Why does early introduction matter? The LEAP study showed that early introduction of peanut is associated with a lower frequency of peanut allergy in high-risk infants. After this groundbreaking study came out, the American Academy of Pediatrics (AAP) and other medical organizations changed the long-standing recommendation around delaying introduction of potentially allergenic foods.

What exactly did the AAP say? Read on to find out!

(infographic of LEAP)

With Aralyte, you can make early peanut introduction structured and convenient from the comfort of your home! Plus, Aralyte is formulated to meet the special dietary needs of infants, with our liquid formulation and daily recommended amount of Vitamin D.

To order, visit our website by clicking here or using the button below.

Warm Regards,
The Aralyte Team

[Mr. Barlow]

Saw the coming of "data-driven" co-opted and overused to the point of rendering it a buzzword like "evidence based" and my favorite, "Data doesn't lie!"  Sure, now let's see the actual fact pattern with a demonstration of unassisted statistical literacy.

Aralyte
@aralyte

The doctor-recommended method for early peanut introduction. Data-driven, structured & convenient.

aralyte.com
Joined October 2016

BTW: Any allergist or FA bloggers out there you may wanna check if you've been RT by Aralyte.  'Cuz you have.

[gvmom]

I think it would be interesting to know who the investors for this product are and if they have any friends that could influence new guidelines that happen to be based on the LEAP study that this product is going to use to push it's product. 

Not to mention, just wondering why they haven't somehow figured a way to just have it declared some sort of dietary supplement that can go on the shelves of any health-food store without all the hullaballoo from the FDA. 

I am just thinking about all of the ways parents will have peace of mind giving their kids these doses of peanut, until some kid has anaphylaxis .... and then they sue the carp out of the company, only to lose because there is no proof that it actually prevents allergies.

..... there really should be one of those smilies that indicates "hmmmm".... you know, rubbing the chin or scratching the head....

[Mr. Barlow]

IMO it's opportunistic capitalizing on the fuzzy risk group guidelines that have been mashed through the sausage maker of social media turning customary products of scholarship into medical self-promotion channels that thus far have not been held accountable - even when med professionals violate their own public institution's social media policy or ethics guidelines. 

I think the LEAP study is solid for the one study it is, and it has nothing to do with these products.  If anything the Antera and Aralyte handles on Twitter are possibly violating FTC guidelines by making it appear blogs, FARE, the Notorious JRB_FARE, and various docs on Twitter are endorsing them.  For me personally the LEAP study served as a catalyst to transfer long term care from Sinai to Stanford for OIT because I see the writing on the wall, this is where the focus will be.  Too many level headed people here have tried private practice OIT with success. 

[lakeswimr]

I'm not surprised by the FDA's reaction.

[gvmom]

IMO it's opportunistic capitalizing on the fuzzy risk group guidelines that have been mashed through the sausage maker of social media turning customary products of scholarship into medical self-promotion channels that thus far have not been held accountable - even when med professionals violate their own public institution's social media policy or ethics guidelines. 

I think the LEAP study is solid for the one study it is, and it has nothing to do with these products.  If anything the Antera and Aralyte handles on Twitter are possibly violating FTC guidelines by making it appear blogs, FARE, the Notorious JRB_FARE, and various docs on Twitter are endorsing them.  For me personally the LEAP study served as a catalyst to transfer long term care from Sinai to Stanford for OIT because I see the writing on the wall, this is where the focus will be.  Too many level headed people here have tried private practice OIT with success.

Yes.... opportunistic capitalizing.... but that is the point when you have one study that is now going to be quoted and used ..... we live in a world where opportunism and capitalism are king, celebrated and held above everything else.  To me, this sort of product is just the tip of the iceberg when you've got the medical establishment altering guidelines 5 minutes after one study comes out. 

Frankly, I'm surprised that the Bamba company isn't flooding the American market with it's products and telling everyone to feed their kids one serving a day because it will help keep allergies away. 

But, it is precisely this type of thing that makes me so annoyed by the publishing and accepting of the LEAP study so quickly by the "establishment".  There really is no accountability these days it seems.  Once things are out on Facebook and twitter... well... now it is fact, the world runs with it, and you aren't able to actually have a moment to assess the actual ramifications & impact. 

And, honestly, if I were one of those companies, I'm not sure if they will have a problem will they?  If you are writing a paper, for example, and you want to prove a point, you can find quotes and selectively edit to make it look like you have weighty support for what you are saying.  Sure, it is sort of sketchy, but is it illegal?  If there is a study out there that says "X".... and the medical establishment now is saying that everyone should follow "X"..... and your product just is about following something that is based on the theory put out by the study, well then isn't your product a legitimate way to follow the guidelines that exist now by legitimate medical establishment? 

I think there will be plenty of companies coming up with products just like this one for all sorts of allergens.  Frankly, why not really?  Why stop at peanuts?  All of the parents out there wanting to prevent their kids from getting food allergies.  Heck, I'd probably start a company that packaged up all sorts of tree nuts and seeds.  You could even maybe have a special order company where you submitted requests for specific allergens. 

I can even imagine that those places that do... what is that.... naturopathic (sp?) testing.... they could have a "and when you get your results do you want us to make some capsules for you to take to help prevent this from worsening?" type tandem business.

And, you have the medical establishment now saying that you should be feeding your kids peanuts early because it prevents peanut allergy.  You know, cause apparently you can know that kids are going to get it.... and you can prevent it.... cause when you don't feed it to them it causes the allergy.  Right?

All those other kids that didn't fit the study, that exist out there with the allergy for real, well.... we won't talk about those kids... and we'll just hope that somehow they don't die at some point. 

Edited to add:  Forgot to mention, that I am also sure there is a pretty decent disclaimer on any product.... including peanut pills.  I am wondering though how many doctors offices will also start issuing disclaimers?

[name]

The FDA has now approved the use of qualified health claims.  Got the news via FARE email.  Consumer products will be able to reference the LEAP study on its labels to "prevent peanut allergy."