The problem isn’t DSHEA — it’s FDA siloing

In a review of recent warning letters, and an investigation of illnesses tied to Diamond Shruumz-brand products, New York-based esquire Marc Ullman of Rivkin Radler LLP asks why the U.S. Food and Drug Administration can’t speak to itself.

Marc Ullman, Of counsel

June 21, 2024

5 Min Read

Siloing: On a farm, a silo prevents different grains from mixing. In an organization, the silo effect limits the interactions between members of different branches of a company, thus leading to reduced productivity.

While recently perusing the FDA website for updates on its activities, I happened upon an FDA Roundup published on Friday, June 14. The roundup contained an item advising that the previous day, “FDA announced the issuance of warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD.”  This item caught my attention for two reasons:

  1. Apparently, FDA’s Center for Tobacco Products (CTP) is able to use a Google search to ferret out noncompliant products without needing to ask Congress for legislation to make its job easier; and

  2. Online retailers that sell products of this ilk might also peddle tianeptine (aka gas station heroin).

At this point, I decided — like the folks at CTP (using a Google search of my own) — to discover what other products the cited companies were offering on their websites. To my surprise, none of the companies receiving the June 12 warning letters (and published on the FDA website on June 13) were advertising tianeptine. However, two of the companies that received a letter from CTP were (as of June 17) selling products or classes of products that FDA has identified as posing potentially serious health risks to consumers — yet these products are nowhere mentioned in the warning letters.

1 Stop Supply Corp. dba 1 Stop Vapor Supply received a warning letter citing its sale of electronic nicotine delivery system (ENDS) and e-liquid products. FDA said it found some of the company’s products “particularly concerning because the design of the Bad Drip Labs e-liquid products (see Exhibits A) [is] likely to appeal to youth by imitating a prescription pill bottle (see Exhibits B). Specifically, the overall presentation of the e-liquid products, including the graphical elements on their labeling and/or advertising, makes it appear that the products are a prescription [drug] and could reasonably result in a child or adult ingesting the products. Further, the products are likely to appeal to youth because they enable youth to conceal a tobacco product from parents, teachers or other adults. FDA is concerned about the rising youth appeal and dramatic rise in youth use of e-liquid products. Any efforts to entice youth to use tobacco products are of concern to FDA.”  

The company’s website also features a variety of kratom products, including Honeyroot Blackout Kratom Shot Trainwreck 215MIT High Alkaloid and Krave Kratom 20 mg Gummies. The latter product with its gummy delivery system would seem to be particularly troubling given the warning letter’s stated concern with product marketing that may appeal to children. FDA has a long history of warning the public of the danger posed by kratom, yet this is never mentioned in the warning letter issued by CTP.

KTX Warehousing & Logistics Ltd. Co. d/b/a VapePuffer received a virtually identical warning letter based upon products offered on its website In addition to all of the issues raised by the 1StopVapor website, this company also sells Diamond Shruumz Extreme Mushroom Gummies and Chocolate Bars purporting to contain a blend of nootropic and functional mushrooms. The chocolate bars also claim to have “HHC Distillate,” which is some sort of CBD concentrate that might contain artificial CBD, included for good measure (“What could go wrong?” you might ask; keep reading).

Let’s momentarily set aside general concerns with the ingredient combination above. On June 11, 2024, FDA and the Centers for Disease Control and Prevention, in collaboration with America’s Poison Centers and state and local partners, issued a warning that they are investigating a series of illnesses associated with eating Diamond Shruumz-brand Chocolate Bars, Cones and Gummies.

FDA’s constituent update noted that a total of 12 illnesses have been reported from eight states, including Alabama (1), Arizona (4), Indiana (2), Kentucky (1), Missouri (1), Nevada (1), Pennsylvania (1) and South Carolina (1). All 12 people reported seeking medical care, and 10 have been hospitalized. By June 18, the number of reported illnesses had risen to 26 across 16 states.

This brings me to the point of this column. How is it possible for one part of FDA to warn these (and other) companies about one set of legal violations on their websites while totally overlooking at least two other issues that the agency has identified as creating public health risks?

I submit that the issue is siloing, which causes one part of FDA to have no idea what any other part is doing. I have been complaining about this problem for years — particularly in relation to the absence of any communication between FDA’s new dietary ingredient notification (NDIN) review program for dietary supplements and the agency’s GRAS (generally recognized as safe) program for food.

Siloing leads to FDA only issuing single-center warning letters (from the likes of CTP, the Center for Food Safety and Applied Nutrition, Center for Drug Evaluation and Research, or Office of Regulatory Affairs). There is no evidence of any communication between the different centers or working groups at FDA. Warning letters are issued citing vaping products but make no reference to other products that are the subject of public health warnings — and another opportunity to protect consumers is missed.


Far more than needing a new statutory definition of what constitutes an adulterated dietary supplement or millions of dollars to fund a mandatory product listing (MPL) for dietary supplements (that scofflaws and criminals will ignore just as much as they ignore current legal requirements), I respectfully submit that mainstream industry and the public health would be better served if Congress devoted its energy to directing FDA to create an office of interagency communications to stop this kind of dangerous siloing. This move would ensure that one hand would talk to another … and that somehow, the information exchanged might finally reach the brain.

About the Author(s)

Marc Ullman

Of counsel , Rivkin Radler

Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration regulatory issues with a focus on the dietary supplement/natural products industry; Federal Trade Commission proceedings and litigation concerning consumer protection compliance and response to enforcement actions, concerning advertising practices, privacy and cyber security. Previously, he practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

Marc’s practice as part of Rivkin Radler’s Health Services Practice Group includes representation of clients on issues relating to FDA compliance, including labels, labeling, claims and good manufacturing practices. He has also represented clients in a number of complex adversarial proceedings with the FDA relating to the scope of the agency’s powers under the Dietary Supplement Health and Education Act of 1994 and its ability to seek remedies such as consumer restitution as well as counseling clients on general litigation related issues and most recently on complex legal issues of concern to the emerging hemp trade in the U.S.

He has represented clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequacy of substantiation of advertising claims. Marc has appeared/testified on behalf of clients before the Food and Drug Administration’s Food Advisory Committee and at the FDA’s 2000 hearing concerning the impact of the First Amendment to the U.S. Constitution on FDA’s regulation of health claims concerning diseases. He has also counseled clients in connection with matters under investigation by the U.S. Congress.

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