Consumers inundated with adulterated and counterfeit supplements, flag global organizations

02 Jun 2020 --- Consumers continue to be at risk of imported adulterated supplements, with the US Natural Products Association (NPA) calling for a two-pronged public-private partnership approach. The US is not the only country to see untrustworthy nutrition products hitting shelves, with Hungary’s National Anti-Counterfeiting Board (HENT) reporting that almost 40 percent of young people have already encountered a counterfeit dietary supplement. This could create major difficulties for an industry reliant on consumer trust.

“Adulterated ingredients that have not completed the New Dietary Ingredient (NDI) notification process are entering our country at an alarming rate and it’s been roughly six years since the Food and Drug Administration (FDA) provided dietary supplement import alerts to prevent this. This puts US consumers at risk and compliant US supplement-makers at a terrible disadvantage,” argues NPA.

According to estimates highlighted by NPA, around 90 percent of dietary supplement products on the market are not required to file an NDI because they have been generally recognized as safe (GRAS). However, this means that approximately 4,600 products on the market have not received FDA scrutiny.

As the first step of NPA’s proposed approach, it is urging the FDA to issue import alerts for nutritional supplements that fail to comply with NDI regulations. According to the association, this alert would require no additional resources. However, it would be an effective way of providing important information to the FDA to facilitate their enforcement of current dietary supplement regulations. 

NPA further adds that an import alert places the responsibility back on the importer to ensure that the products being imported into the US are in compliance with the FDA’s laws and regulations. The agency last used this authority in 2014 in response to safety concerns related to the importation of Kratom.

Bolstering SSCI
The second recommendation is to expand the number of companies that agree to meet industry-specific quality assurance standards in NPA’s Supplement Safety and Compliance Initiative (SSCI). SSCI is touted as an industry-driven initiative led by major US retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers in order to achieve the goal of providing quality products and increasing consumer confidence. 

NPA is also concerned that the FDA is falling behind on the Food Safety Modernization Act (FSMA) inspectional cycle, noting that in FY 2019, there were less than 50 notifications submitted to the FDA to establish the safety of new dietary ingredients in supplements.

However, the FDA has been taking action on numerous cases in recent weeks, having warned around 50 companies for selling products that misleadingly represent the products as being safe or effective for the prevention or treatment of COVID-19. Meanwhile, the US state of Oregon recently adopted stricter measures to crack down on COVID-19 claims. 

Diet pills from counterfeit or uncontrolled sources can be particularly dangerous to health.Hungry for accuracy
Across the Atlantic, Hungarian consumers are also at risk of taking misleading nutritional products, as revealed by HENT’s survey into young people’s attitudes toward counterfeit products (translated from Hungarian). The board reveals that 39 percent of 18 to 26-year-olds have already encountered some form of counterfeit dietary supplement. The research also found that 67 percent of young adults consider the Internet to be the most popular channel for distributing counterfeits.

However, HENT notes that diet pills from counterfeit or uncontrolled sources can be particularly dangerous to health, as reliable information on their actual composition cannot be obtained without proper quality control. Notably, the vast majority of these types of products are considered food supplements, which do not need to go through a pre-market testing process in the EU. Hungary’s Safe Dietary Supplement Program is already partnered with 1,600 pharmacies, guaranteeing that only controlled and high-quality products reach consumers.

“Certain weight loss products, combined with proper diet and exercise, can indeed be a solution for those struggling with weight problems. However, [it is suspicious] if an online ad offers us an unknown ‘miracle pill.’ The legal requirements are clear that the use of claims that refer to the rate or extent of weight loss is prohibited,” says Gyula Pomázi, President of the National Office of Intellectual Property, Deputy President of HENT.

Prior HENT surveys show that there has been a significant increase in food supplement demand among 18 to 22-year-olds, with people who took them rising from 31 percent in 2018 to 47 percent the next year. 

Additionally, more than three-quarters of respondents in 2019 were aware that dietary supplements serve to supplement the traditional diet (for example, with vitamins and minerals), an increase of nearly ten percentage points from the 2018 result.

Edited by Katherine Durrell