GABA Labs Now Sells Sentia in the US: This herbal blend uses deceptive marketing to drive sales but do these advertisements violate US law?

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 Why Sentia by GABA Labs May Violate DSHEA Guidelines: A Closer Look at Psychoactive Claims


Introduction

In recent years, Sentia by GABA Labs has garnered attention in the United States as a purported “alcohol alternative” beverage that promotes relaxation or mood enhancement. While marketed under the umbrella of dietary supplements, the product’s emphasis on psychoactive effects raises important regulatory questions under the Dietary Supplement Health and Education Act (DSHEA). This article explores how Sentia may be crossing the line from lawful dietary supplement to an unapproved new drug, based on U.S. Food and Drug Administration (FDA) standards—and how GABA Labs’ own published content referencing outside psychoactive claims could invite regulatory scrutiny.

DSHEA Basics and the FDA’s Position

Under DSHEA (1994), dietary supplements are not subject to the same premarket approval that drugs require. Nonetheless, they must adhere to strict rules regarding labeling and marketing, particularly:

  1. No Disease or Drug-Like Claims
     Dietary supplements cannot be marketed as diagnosing, treating, curing, or preventing any disease. Nor can they overtly claim drug-like psychoactive or intoxicating effects.
  2. Structure/Function Claims Only
     While the FDA allows “structure/function” claims (e.g., “supports a calm mood,” “promotes relaxation”), these must be truthful and not misleading, supported by some evidence, and accompanied by the standard disclaimer:

    “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
  3. No “Adoption” of Unapproved Claims
     Even if a company does not directly author certain claims, it can still be held responsible for “adopting” statements—such as consumer testimonials or press coverage—if it endorses, republishes, or otherwise draws attention to those statements in its own promotional channels.

GABA Labs’ Sentia: The Marketing vs. DSHEA Compliance

  1. Positioning as a Psychoactive Alcohol Alternative
     Sentia is promoted as an “alcohol-free” beverage that may generate a similar “buzz” or relaxation effect associated with alcohol—descriptions that drift closer to drug-like or psychoactive benefit claims, rather than the permissible “structure/function” language typical of dietary supplements.
  2. Potential Issues with “Intended Use”
  • The FDA classifies products by their intended use, which is determined by the totality of marketing materials, labeling, websites, and any endorsements the company makes.
  • If the product is consistently described (explicitly or implicitly) as inducing a psychoactive state—rather than simply “supporting a healthy mood”—the FDA may interpret Sentia’s intended use as a drug-like function, rather than a mere dietary supplement.

  1. Endorsing Third-Party Claims
  • Publicly available information suggests that GABA Labs (the maker of Sentia) cites or endorses articles and press coverage describing Sentia’s psychoactive benefits on their “News” page (see: GABA Labs News).
  • Under FDA guidance, if a company highlights external content that makes unapproved claims—especially references to psychoactive or intoxicating effects—that content can be viewed as an extension of the company’s own promotional materials.

How Outside Claims Become the Company’s Claims

1. Adoption of Third-Party Statements

When a dietary supplement company shares, links to, or quotes third-party sources praising the product’s psychoactive or therapeutic effects, the FDA may conclude the company is effectively “adopting” those claims.

  • Example Scenario:
  • A blogger writes that Sentia “makes you feel happily buzzed, just like a glass of wine.”
  • GABA Labs then links to or reposts this on their website, possibly framing the article as an endorsement.
  • The FDA can argue GABA Labs is promoting an unapproved drug-like claim, thus violating DSHEA and the Federal Food, Drug, and Cosmetic Act.

2. Risk of Drug Classification

If enough of these psychoactive or mood-altering claims are highlighted by GABA Labs, the FDA might classify Sentia as intended for use as a new drug, which would require premarket approval—something GABA Labs presumably does not have.

Precedents in FDA Enforcement

Though publicly available enforcement actions specifically targeting Sentia are not currently evident, the FDA has issued warning letters in similar scenarios where companies:

  • Published user testimonials or news articles claiming the product “treats anxiety,” “reduces stress,” or “replicates the effects of alcohol.”
  • Presented the product as psychoactive or capable of yielding an inebriating effect.
  • Endorsed or redirected consumers to websites touting unapproved drug benefits.

CBD companies, for instance, have faced warning letters for reposting statements about treating ailments like chronic pain or anxiety—despite not making those claims themselves in official statements. The FDA’s rationale: hosting or pointing users to such claims is tantamount to making the claims directly.

Why This Matters: DSHEA Violations

  1. Unauthorized Drug Claims
     By emphasizing or endorsing psychoactive or “buzz-like” attributes, a product crosses the threshold from a lawful dietary supplement to an unapproved drug. This is the very heart of a DSHEA violation.
  2. Consumer Protection & Safety
     The FDA’s concern is partly driven by consumer safety. When a product is marketed with psychoactive claims, consumers might rely on it as a safer alternative to alcohol or pharmaceuticals—without scientific verification or FDA oversight.
  3. Potential Enforcement Actions
     If the FDA concludes Sentia is being sold as an unapproved new drug, it could send warning letters, seize the product, or even seek injunctions. Typically, the FDA’s first step is a warning letter outlining violations and demanding corrective action.

Conclusion

Sentia by GABA Labs occupies a hazy regulatory space where it is purportedly sold as a “dietary supplement,” yet its marketing and referenced third-party coverage highlight psychoactive effects akin to those of alcohol. Under DSHEA and FDA regulations:

  1. Merely calling a product a “dietary supplement” does not exempt it from the FD&C Act’s strict rules against unapproved drug claims.
  2. Companies are held accountable not only for their direct statements but for third-party content they endorse or promote—particularly if those endorsements emphasize psychoactive or therapeutic results.
  3. If the FDA deems Sentia’s intended use to be producing a psychoactive or intoxicating state, rather than modest structure/function benefits, GABA Labs could face enforcement actions for effectively marketing an unapproved drug.

Until GABA Labs adjusts its marketing approach—and ceases highlighting psychoactive claims, either directly or indirectly—it remains at risk of DSHEA noncompliance. While there is no public record of an FDA warning letter specifically targeting Sentia at this time, the path that other companies have tread suggests the agency may yet take action if these practices persist.

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