By Sean Moloughney, Editor06.02.22
Occasionally I’ll see an article or a press release that suggests, implies, or flatly declares dietary supplements are “unregulated.” If you’ve been in this industry long enough, no doubt you have too. It’s true that FDA does not currently have premarket approval powers for finished dietary supplements. However, to conclude that supplements are therefore “unregulated” is a huge leap that ignores all the detail and nuance of food and drug law.
While FDA may not use all its regulatory authority, the agency still has those enforcement mechanisms at its disposal. I may not be using the exercise bike in my basement, but I can’t deny that it’s still in my house.
American Herbal Products Association (AHPA) President Michael McGuffin wrote a column for this issue that outlines the requirements for dietary supplements under applicable federal regulations, including facility registration, good manufacturing practices, labeling, product claims, and more. “Altogether, dietary supplement regulations are not only robust, but, in most cases, are as strict or stricter than those that govern conventional foods,” McGuffin wrote.
He also covered serious adverse event reporting (SAER), which the industry advocated for, as well as FDA’s mandatory recall authority. Reviewing the data, he concluded, “With fewer recalls than conventional foods and beverages, drugs, animal and veterinary products, and medical devices, dietary supplements could arguably be considered the safest class of goods regulated by FDA.”
I encourage you to read and share his column to help counter the narrative that supplements are not regulated. Debate about mandatory product listing aside for a moment, it’s important to reinforce that there is a regulatory framework for dietary supplements in place, especially as consumer demand for health and nutrition products continues to grow.
For example, as shown in this issue, the term “adaptogens” has hit on something worth analyzing, namely that people are experiencing historic levels of stress, and they’re looking for relief.
A Harris Poll fielded Mar. 1-3 on behalf of the American Psychological Association (APA), revealed that more adults rate inflation and issues related to the invasion of Ukraine as stressors than any other issue asked about in the 15-year history of APA’s Stress in America poll.
Top sources of stress were the rise in prices of everyday items due to inflation (e.g., gas prices, energy bills, grocery costs, etc.) (cited by 87%), followed by supply chain issues (81%), global uncertainty (81%), Russia’s invasion of Ukraine (80%), and potential retaliation from Russia (e.g., in the form of cyberattacks or nuclear threats) (80%).
This all comes on top of financial stress that was already at the highest recorded level since 2015, according to a broader Stress in America poll fielded in February.
“Daily stress has become normalized,” noted Holly Johnson, chief science officer at AHPA. “Both acute and long-term exposure to various stressors can lead to decreased physical and mental performance, and also stress-related illnesses including anxiety, depression, memory impairment, and hypertension, among others.”
Effective tools for managing stress, cognitive health, and mental wellbeing are “increasingly critical to our everyday existence,” she added.
While FDA may not use all its regulatory authority, the agency still has those enforcement mechanisms at its disposal. I may not be using the exercise bike in my basement, but I can’t deny that it’s still in my house.
American Herbal Products Association (AHPA) President Michael McGuffin wrote a column for this issue that outlines the requirements for dietary supplements under applicable federal regulations, including facility registration, good manufacturing practices, labeling, product claims, and more. “Altogether, dietary supplement regulations are not only robust, but, in most cases, are as strict or stricter than those that govern conventional foods,” McGuffin wrote.
He also covered serious adverse event reporting (SAER), which the industry advocated for, as well as FDA’s mandatory recall authority. Reviewing the data, he concluded, “With fewer recalls than conventional foods and beverages, drugs, animal and veterinary products, and medical devices, dietary supplements could arguably be considered the safest class of goods regulated by FDA.”
I encourage you to read and share his column to help counter the narrative that supplements are not regulated. Debate about mandatory product listing aside for a moment, it’s important to reinforce that there is a regulatory framework for dietary supplements in place, especially as consumer demand for health and nutrition products continues to grow.
For example, as shown in this issue, the term “adaptogens” has hit on something worth analyzing, namely that people are experiencing historic levels of stress, and they’re looking for relief.
A Harris Poll fielded Mar. 1-3 on behalf of the American Psychological Association (APA), revealed that more adults rate inflation and issues related to the invasion of Ukraine as stressors than any other issue asked about in the 15-year history of APA’s Stress in America poll.
Top sources of stress were the rise in prices of everyday items due to inflation (e.g., gas prices, energy bills, grocery costs, etc.) (cited by 87%), followed by supply chain issues (81%), global uncertainty (81%), Russia’s invasion of Ukraine (80%), and potential retaliation from Russia (e.g., in the form of cyberattacks or nuclear threats) (80%).
This all comes on top of financial stress that was already at the highest recorded level since 2015, according to a broader Stress in America poll fielded in February.
“Daily stress has become normalized,” noted Holly Johnson, chief science officer at AHPA. “Both acute and long-term exposure to various stressors can lead to decreased physical and mental performance, and also stress-related illnesses including anxiety, depression, memory impairment, and hypertension, among others.”
Effective tools for managing stress, cognitive health, and mental wellbeing are “increasingly critical to our everyday existence,” she added.
