Unveiling the Dilution Dilemma in Botanical Extracts

An article published in HerbalGram titled "The Undisclosed Presence of Excipients and Diluents in Botanical Extracts," by Stefan Gafner and co-authors, spotlighted the pervasive issue of dilution within the botanical supplement industry. This practice, which reduces the potency of active ingredients, has been labeled as consumer fraud.

The Issue of Overdilution

Overdilution involves suppliers in the botanical value chain cutting extracts with excessive amounts of excipients—undeclared substances that dilute active ingredients—misleading consumers about the potency of supplements. While the adulteration of botanical products is not new, this problem has attained a scale that requires urgent attention.

Stefan Gafner, Chief Science Officer at the American Botanical Council, highlighted the need to address this issue within the Botanical Adulterants Prevention Program (BAPP). BAPP, along with experts like James Kababick of Flora Research Laboratories, has collected evidence since 2018 to bolster the case against this malpractice.

Methods of Fraud

HerbalGram outlines two primary methods of dilution: excessive excipients added to botanical extracts and the remarketing of spent biomass (marc) without disclosing prior extraction. These practices impact a wide range of botanicals, from ginkgo to black cohosh, and are rampant throughout the industry.

Excipient overload, involving substances like maltodextrin, challenges authentication and potency testing. Meanwhile, the resale of marc, equivalent to reusing coffee grounds, cheats consumers who believe they are purchasing potent products.

Industry's Reaction

Key figures in the industry, such as Michael Levin of Health Business Strategies, stress the consumer deception involved, emphasizing greed as the driving force. The supplement industry, already familiar with adulteration tactics, now focuses on combatting dilution through stricter controls and transparency.

Elan Sudberg, CEO of Alkemist Labs, underscored the common practice of using microscopy to detect diluents, marveling at the industry's negligence in thorough testing. Companies like Arizona Nutritional Supplements enforce stringent quality checks to dissuade dilution infractions, likening their process to identifying inferior product offers that undercut market norms.

Paths to Resolution

Resolving the problem of overdilution demands multiple measures. Regulatory clarity stands foremost, with a need to define "extract" comprehensively and legislate the disclosure of native extracts along with excipients. Aligning FDA regulations with industry best practices will curb malpractices concealed by vague definitions.

Enhanced analytical testing and the adoption of robust methodologies are crucial for detecting and preventing dilution. Comprehensive testing can prevent fraudulent substances from entering supply chains, enhancing the quality and efficacy of botanicals on the market.

Additionally, experts advocate for rigorous specifications in ingredient contracts and agreements with suppliers, asserting clear quality standards. The mantra "burn it, don’t return it" highlights the necessity to eliminate adulterated products from commerce, stressing the importance of destroying substandard goods to maintain integrity.

As the industry confronts the widespread issue of botanical dilution, comprehensive solutions—ranging from better regulations to thorough testing and contract specifications—are vital for safeguarding consumer trust and ensuring product authenticity.