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Regulatory Focus™ > News Articles > What's a Dietary Supplement? Definition of 'Ingestion' Continues to Lead to Warning Letters

What's a Dietary Supplement? Definition of 'Ingestion' Continues to Lead to Warning Letters

Posted 06 June 2013 | By Alexander Gaffney, RAC

Dietary supplement manufacturers have long been infamous for their chronic noncompliance with federal regulations, and in particular those related to good manufacturing practices (GMPs) and proper branding. But a Warning Letter released this week has the agency taking aim at a supplement manufacturer for an issue rarely cited in recent years: A banned method of consumption.


Under Section 201(ff)(2)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act), dietary supplements-technically regulated as a food product, not a pharmaceutical-must be "ingested" via an oral route.

While this may seem intuitive to some, 20 companies have received Warning Letters from FDA since 2001 referencing their failure to market a dietary supplement product ingested orally. Since January 2011, only three letters have referenced the problem, making it relatively rare among the deluge of Warning Letters sent to supplement manufacturers in recent years.

In the case or Earthborn Products of San Diego, CA, the company marketed a number of products that failed the standard of 201(FF)(2)(A), including eye drops, nose drops, an anti-fungal spray, a topical ointment, and a vaginally-based treatment.

"We note that only products that are intended for ingestion may be lawfully marketed as dietary supplements," FDA said. "Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal products, are not dietary supplements. For such products, both disease and structure/function claims may cause them to be new drugs."

The distinction has tripped up a small handful of companies in recent years. For example, a 2012 Warning Letter to Breathable Foods chided the company for marketing its inhalable caffeine product AeroShot as a supplement.

"Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied," wrote FDA in the warning letter. "While the company claims on its website that decades of research have established that the particles in AeroShot are too big to enter the lungs, the company does not point to any specific research in support of this claim."

The company had tried to maintain that its product was intended to be swallowed, but FDA said its marketing materials indicated that it was intended to be inhaled.

Violations go Back to 2001

Other companies running afoul of the 201(ff)(2)(A)provision include:

  • Evol Nutrition Associates, whose 2012 Warning Letter references a "Spark 4-D Happy Caps" product that dissolves in a person's mouth and is absorbed through the mouth's mucosal tissue.
  • RT Naturals, whose 2010 Warning Letter also references a product intended to be dissolved in the mouth and absorbed through mucosal tissue.
  • Atlas Operations, the recipient of a 2010 Warning Letter regarding a number of products intended to enter the body through the skin or mucosal tissues.
  • Healthy World Distributing, the recipient of a 2010 Warning Letter referencing a topical product called Oxysilver.
  •, the recipient of a 2009 Warning Letter, for a topically-applied supplement product.
  • Prismic Light International, the recipient of a 2008 Warning Letter, for marketing a transdermal patch as a dietary supplement.
  • Beehive Botanicals and Health Freedom Nutrition, the recipients of 2007 Warning Letters for marketing dietary supplements intended to be applied by sprays, balms and creams.
  • Ana-Tech and Can-X Products, both recipients of Warning Letters in 2005, for marketing supplements intended to be applied through a skin cream.

Though some cases test the boundaries of FDA's regulatory authority under 201(ff)(2)(A)-especially that of Breathable Foods-the moral of the story is clear: If you're marketing your product as a supplement while maintaining that it can be consumed any way other than oral ingestion, be prepared to get a warning from US regulators.

A full list of violations may be found here.


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