In the second article in a series on health claims, NutraIngredients-USA.com examines what FDA looks for when regulating the use of claims on food, beverage and dietary supplements.
FDA, which regulates the use of health claims on product labels, has three major types of enforcement options: advisory, administrative and judicial.
According to Jennifer Thomas, director of Division Enforcement at FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of Compliance, advisory action is the most frequent enforcement option pursued by the agency.
"We almost always give people the opportunity to make corrections," she told industry members attending a presentation at Expo West in Anaheim, California last month.
Advisory action takes the form of a warning letter, an 'untitiled' or a cyber letter.
This type of action can take the form of import alerts or refusals, as well as product detention.
It can also lead to FDA suspending or revoking a license, to civil money penalties, and to debarment or disqualification.
Judicial action involves seizure, injunction, or criminal prosecution.
FDA evaluates all claims or statements made on product labels, packaging, or accompanying material. As well as direct claims, FDA also evaluates implied statements or images.
Promotional material or product advertising is not directly regulated by FDA (these are handled by the Federal Trade Commission), but may be used to establish intended use, said Thomas.
The key principles FDA adheres to are that claims must be truthful, not misleading and appropriate to the product they are used on.
According to Thomas, the agency's highest priority is to clamp down on products that pose a direct health hazard.
Following that, are indirect health hazards. These are more frequent and are considered on a case-by-case basis.
When evaluating health claim use, FDA considers the following:
- Whether claims are significant
- Vulnerability of user group (elderly, children, etc)
- Center enforcement strategies and priorities
- Number of users affected
- Economic impact (product cost, amount sold etc)
- Agency resources
FDA looks out for a number of things that could signify health fraud. These include:
- Fake or inflated credentials
- Money back guarantee
- 'All-natural' & 'safer' than conventional treatment
- 'Quick fixes' for conditions such as hair loss, overweight
- 'They don't want you to know about it'
Other claims that help the agency to identify health fraud include statements that a product may treat or cure serious or incurable conditions such as cancer, diabetes, arthritis or Alzheimer's.
A 'one product treats all' claim also flags up fraud to FDA, as well as statements such as 'new discovery', 'scientific breakthrough', 'secret formula', and 'ancient remedy'.
Thomas said FDA also looks out for impressive-sounding scientific terms or ingredient names, as well as products that claim benefits relying on personal or expert testimonies.
Examples of FDA's enforcement actions include last year's seizure of seven supplements and pamphlets valued at $41,000 from Charron Nutrition.
The stock, which was seized by US marshals in Florida at FDA's request, included Glucobetic, Neuro-betic, Ocu-comp, Atri-oxi, Super-flex, MSM-1000, and Atri-E-400 capsules.
These were being distributed and promoted by Tallahassee-based Charron Nutrition for use in treating diabetes, arthritis and other serious health conditions.
Just several months later, in October 2007, FDA again took action against dietary supplements being promoted with drug claims to cure or treat diabetes and other conditions.
This time, the agency seized $71,000 of goods from Fullife Natural Options, based in Boca Raton, Florida.
The company marketed and distributed Charantea Ampalaya capsules and Charantea Ampalaya tea for use in treating serious conditions, such as diabetes, anemia, and hypertension.
"The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease," wrote Joseph Baca, from the Center for Food Safety and Applied Nutrition, to marketers in an October 2006 warning letter. "The marketing of this product with these claims violates the Act (Federal Food, Drug and Cosmetic Act)."
Other articles in the series: