Last week’s top headlines included a review from the Botanical Adulterants Prevention Program of ginseng adulteration, EFSA’s DHA levels, ANH-USA lawsuit against the U.S. FDA, and Aker Biomarine’s strategy for India.
Ginseng adulteration remains a significant concern
Almost 25% of commercial ginseng products may be adulterated, with dietary supplements at greater risk than powdered ginseng root or ginseng tea, says a new scoping review from the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP).
The paper, published in Natural Product Communications, summarizes information on the authenticity of 910 commercial ginseng products reported in 48 peer-reviewed publications. Results from 40 of these studies showed that 211 of 853 commercial ginseng products (24.7%) were found to be adulterated, mainly due to substitution of the declared species with powdered roots or extracts from lower-cost plants.
Eight additional studies reported the undisclosed presence of active pharmaceutical ingredients in 28 of the 57 ginseng products (49.1%) tested, wrote Nilüfer Orhan, PhD, a research scientist at the American Botanical Council (ABC) and BAPP; Stefan Gafner, PhD, chief science officer of ABC; and Mark Blumenthal, founder and executive director of ABC.
“The information gathered suggests that ginseng adulteration is a persistent problem,” stated Dr. Gafner in an ABC press release. “In most cases, this happens for financial gain, even if information from colleagues who are in the ginseng business suggests that costs of Asian and American ginseng roots are very similar. However, the sale price depends a lot on the type of roots, with main roots fetching the highest price, while slender roots are available at a much lower cost. Hence, economically motivated adulteration seems to be mostly driven by price differences in the quality of the root material rather than the species.”
EFSA sets ‘conservative’ safe intake level for DHA
EFSA has published its scientific opinion on the safe level of supplemental docosahexaenoic acid (DHA) following concerns that sustained use could increase the risk of spontaneous bleeding.
The scientific regulatory agency conducted a systematic review of the available literature and concluded that the safe level is 1 gram per day—a ‘conservative approach’, according to Jerome Le Bloch, head of scientific affairs at FoodChain ID.
The decision means that the safe level remains unchanged since EFSA’s last scientific opinion, which was published in 2012. This time around, EFSA was also due to determine a Tolerable Upper Intake Level (UL)—the maximum total daily amount of a nutrient unlikely to cause adverse health effects. However, as in 2012, the UL could not be established.
“Setting up a UL requires the identification of a clear reference point, typically based on a well-characterized adverse effect and a robust dose-response relationship,” Le Bloch told NutraIngredients.
In this case, EFSA identified spontaneous bleeding as the most critical potential adverse effect associated with high DHA intake. However, the available data were insufficient to establish a reliable dose-response relationship for DHA alone.
“Given these uncertainties, EFSA adopted a conservative and protective approach, defining a safe level of intake at which no adverse effects have been observed,” he explained. “Importantly, this does not imply that intakes above 1 g/day are unsafe, but rather that the current evidence base does not allow EFSA to scientifically justify a higher intake level as a formal UL.”
ANH-USA sues FDA over nutrient–disease claims rejection
The Alliance for Natural Health USA (ANH-USA) has filed a federal lawsuit against the U.S. Food and Drug Administration (FDA) over the agency’s recent rejection of a petition to allow over 110 ‘government-backed’ disease risk reduction health claims.
The lawsuit contends that the FDA violated the plain meaning of the authoritative statement provisions of the Food, Drug, and Cosmetic Act, the Constitutional Avoidance Doctrine and the First Amendment by suppressing these claims.
“FDA has apparently still not learned the lesson of the landmark 1999 health claims decision of the U.S. Court of Appeals in Pearson v. Shalala, that it may not suppress health claims unless it marshals empirical evidence that they are false and that no claim qualification will suffice to eliminate potential misleadingness,” stated Jonathan Emord, Esq., general counsel at ANH, in a press release. “Instead, it has refused to follow Pearson v. Shalala and is now asked to be accountable for that failing.”
Pearson v. Shalala ruled that the FDA’s “significant scientific agreement” standard for approving health claims on dietary supplements violated the First Amendment’s commercial speech protections. The court decided that the agency may not suppress truthful, non-misleading health claims unless it can prove, with affirmative evidence, that the claims are false. Emord argued the Pearson case.
Omega-3 in India: Aker Biomarine sets sights on three key growth categories
Aker Biomarine is gearing up for growth in India’s omega-3 market, with a new country manager and distributor on board to drive growth from dietary supplement companies, multinational food companies, and the nutraceutical arm of pharmaceutical companies.
Aker Biomarine has been present in the Indian market for over 10 years. However, following the separation of its aquaculture business two years ago, the company has taken a “ground-up” approach in building its human health ingredients business, especially for diverse markets like India.
This month, Aker Biomarine appointed Hidayat Ali, a registered pharmacist and most recently from Kappa Bioscience, as the country director of its operations in India.
The company also signed a new distribution partnership with G.C. Chemie Pharmie Pvt. Ltd. (GCCPL) to expand access to its omega-3 ingredients in India. Aker Biomarine is also exhibiting at Vitafoods India 2026 in Mumbai next month.
As the most populous country in the world with a growing middle class, the company sees India as a key future market for long-term growth.
“While we’ve been in India for 12 years, we feel that this shift with Ali on the ground and the relationship with G.C. Chemie Pharmie represents the next phase of our growth in India, because we now have a 100% focus on our human health ingredient portfolio,” Ross Norris, general manager Asia Pacific, Aker BioMarine, told NutraIngredients. “My experience in India is that you cannot beat having a local presence. It demands a high level of service, a very responsive sales team, and with Ali and G.C. Chemie Pharmie, we can now thankfully deliver that.”
