Domestic Facility Risk Categorization and Risk-Based Inspection Frequencies

The FDA Food Safety Modernization Act (FSMA) created section 421 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates FDA inspection frequency based on risk for domestic food facilities that are required to register under FD&C Act section 415. Specifically, section 421 mandates inspection frequencies based on a facility being identified as high-risk (HR) or non-high-risk (NHR). HR facilities must be inspected at least once in the first 5 years following enactment of FSMA and then once every 3 years. NHR facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years. These inspection frequencies are a minimum and some firms may be inspected on a more frequent basis. 

FDA estimates the inventory for high-risk facilities at 22,325 and non-high-risk at 60,000.  For FY 2012, approximately 7,400 HR and 8,600 NHR facilities are planned for inspections. FDA plans to inspect HR facilities every 3 years although the new legislation provides an initial frequency mandate of inspecting each HR facility once in a 5-year period

Factors in Risk Categorization (FY 2011-13)

FSMA Identified Risk Factors*	Data Elements
Known safety risks of the food	Class 1 Recalls** Foodborne illness outbreaks
Compliance history of a facility	Inspection Classifications Facilities with significant violations Facilities with a history of non-compliance
Facility’s hazard analysis and risk-based preventive controls	Limited data
Priority under section 801(h)(1)	Applicable to foreign facilities only
Certifications for imported food	Programs not yet established
Any other criteria deemed necessary	Type of activity (establishment type) Years since last inspection

Adapted from FDA, FSMA Domestic Facility Risk Categorization (FY 2012). 

The risk categorizations are expected to evolve as FDA gathers data on the new risk-based preventive controls and certifications are developed for imported foods.  The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls will be an important factor in the future. At this time, FDA is basically determining risk in a three step process based on some of the above factors:

1. Known safety risks of the food - Whether facility packs, processes or holds a commodity that has been identified with known food safety risks; that is, food commodities associated with outbreaks and/or Class-I recalls.

2.  Years since last inspection. 

3.  Compliance history - History of significant violations or non-compliance.

AeroShot “Caffeine Inhaler”

FDA issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their “caffeine inhaler.” FDA finds the labeling false or misleading because the company claims use for both inhalation and ingestion. Breathable Foods claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The company also claims that its product is intended to be ingested by swallowing. FDA states that a product cannot be intended for both inhaling and swallowing, noting that human anatomy does not permit simultaneous inhalation and ingestion.

FDA continues that, “By definition, dietary supplements must be intended for ingestion.” See FDCA §§  201(ff)(2)(A) and 411(c)(1)(B) [21 U.S.C. §§ 321(ff)(2)(A) and 350(c)(1)(B)].  “A product intended for inhalation is not a dietary supplement.” Surprisingly, FDA did not state the consequence of failing to be a dietary supplement — as far as it is intended for caffeine inhalation, Aeroshot would be a drug and medical device.  I cover this in my book, Food Regulation: Law, Science, Policy, and Practice, in discussion of the case, United States v. Ten Cartons of Ener-B Nasal Gel.       

FDA is also concerned about AeroShot’s because of questions about its safety. Terms such as “caffeine inhaler” and “breathable energy” may encourage consumers to try to inhale AeroShot into their lungs. Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied.  

The FDA also expressed concern about the use of AeroShot by children and adolescents.  The company’s website indicates that AeroShot is “not recommended for those under 18 years of age,” but the product label states that it is “not intended for people under 12.”  

FDA is also concerned about AeroShot website links to news articles and videos that refer to use of the product in conjunction with drinking alcohol.  While using caffeine when drinking may lead consumers to feel “less drunk,” it does not reduce blood alcohol levels. FDA states, “Data and expert opinion also indicate that caffeine decreases the perception of intoxication, meaning that individuals who consume caffeine along with alcohol may consume more alcohol than they otherwise would and become more intoxicated than they realize. At the same time, caffeine does not change blood alcohol content levels, and thus does not reduce the risk of harm associated with drinking alcohol.”

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius.