The Food Safety Modernization Act (FSMA) requires many deliverables from FDA, among them special reports and studies to be submitted to Congress.
Submitted February 2015
Annual Report to Congress on the Use of Mandatory Recall Authority
Submitted Pursuant to Section 206 of the FDA Food Safety Modernization Act, Public Law 111-353
U.S. Department of Health and Human Services
Food and Drug Administration
On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353). Section 206(a) of FSMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 423 (21 U.S.C. § 350l) giving FDA for the first time, mandatory recall authority over responsible parties with respect to all FDA-regulated foods other than infant formula. FSMA requires the Department of Health and Human Services (HHS) to submit a report to Congress on the use of recall authority under section 423 of the FD&C Act and any public health advisories issued by FDA that advise against the consumption of an article of food on the grounds that it is adulterated and poses an imminent danger to health. Specifically, FSMA section 206(f) states:
(1) In general.--Not later than 2 years after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this subsection as the "Secretary") shall submit a report to the Committee [[Page 124 STAT. 3944]] on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 423 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
(2) Content.--The report under paragraph (1) shall include, with respect to the report year--
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 417 of the Federal Food, Drug, and Cosmetic Act, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 423(a) of such Act;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 423(a) of the Federal Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section 423(b) of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 423(b) of the Federal Food, Drug, and Cosmetic Act or a public health advisory described in paragraph (1).
This is the second annual report in response to this mandate since FSMA was enacted. It covers the reporting requirements relating to the use of recall authority under section 423 of the FD&C Act during fiscal year (FY) 2014. The previous report indicated that FDA was considering which of its public communications fall under the category of “public health advisories” as described in FSMA section 206(f). Given that the requirement to report “public health advisories” was imposed by the same section of FSMA that granted FDA mandatory recall authority under section 423 of the FD&C Act, the Agency is interpreting the term “public health advisories” in this context to apply only to communications made to the public when the mandatory recall process has been initiated (i.e., a letter under section 423 of the FD&C Act has been sent). FDA issues many other types of communications (e.g., consumer advisories, warning letters, and reports of outbreak investigations) that may advise against the consumption of specific articles of food, notify the public of a danger to health, or indicate that a food is adulterated. These various and important communications are available on FDA’s website. However, since these are not “public health advisories” as described in section 206(f) of FSMA, FDA is not including them in this report.
While the American food supply is among the safest in the world, according to recent data from the Centers for Disease Control and Prevention (CDC), there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year. Moreover, each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. This is a significant public health burden that is largely preventable. FSMA enables FDA to better protect public health by strengthening food safety measures. Under the new law, FDA now has much more effective enforcement tools to protect the food supply. These enforcement tools include the authority to issue a mandatory recall order under section 423 of the FD&C Act for an article of food, other than infant formula, for which FDA determines there is a “reasonable probability” that the food is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act and that the use of or exposure to that food will cause serious adverse health consequences or death to humans or animals.
In order to issue such a mandatory recall order, FDA must first provide the responsible party with the opportunity to cease distribution and to conduct a voluntary recall of the article of food in question. If the responsible party refuses to, or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, the Agency may proceed under the mandatory recall authority as set forth in section 423 of the FD&C Act. Should the Secretary order the responsible party to cease distribution and to give notice to other persons in the distribution chain, the responsible party has the opportunity to request a hearing to be held within 2 days to contest the order and convince FDA that the article of food should not be recalled.
Prior to the enactment of FSMA, FDA generally had to rely upon manufacturers’ voluntary recall efforts or obtain a court order to remove contaminated or misbranded foods, other than infant formula, from the food supply.
In FY 2014, FDA issued a Notification of Opportunity to Initiate a Voluntary Recall letter to USPlabs, LLC of Dallas, Texas, giving the firm an opportunity to cease distribution and recall an article of food under the mandatory recall authority granted by FSMA. The action marks the second time the Agency has exercised its recall authority under FSMA by sending such a letter. Additionally, FDA issued three public health advisories in FY 2014 related to this exercise of authority.
In 2013, FDA, along with CDC, the Department of Defense (DoD) Armed Forces Health Surveillance Center, and state and local health officials, investigated an outbreak of acute non-viral hepatitis that began in Hawaii.
According to CDC, 97 people with acute non-viral hepatitis were identified in this outbreak, 72 of whom had reported exposure to an OxyElite Pro branded product. Of these cases, at least 47 were hospitalized, at least 3 received a liver transplant, and 1 death was reported. The estimated illness onset dates ranged from April 10, 2013, to October 24, 2013.
On October 11, 2013, FDA issued a warning letter to USPlabs, LLC informing the company that the dietary supplements OxyElite Pro and VERSA-1 were adulterated, and that failure to immediately cease distribution of these products could result in enforcement action. The warning letter stated that the products were deemed to be adulterated because they contained aegeline, a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) that was not the subject of a required notification to FDA.
Specifically, USPlabs, LLC failed to provide FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was reasonably expected to be safe for use in its dietary supplements.
In a letter dated November 6, 2013, FDA notified USPlabs, LLC about findings indicating a link between the use of certain OxyElite Pro products and a cluster of liver illnesses reported in Hawaii. The letter also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states and summarized the results of FDA’s review of 46 medical records of cases from the outbreak. The reviewed records indicated that 27 of the 46 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of these 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death had occurred among these patients, another patient had required a liver transplant, and others were awaiting liver transplants. Based on review of the medical records and other evidence obtained in FDA’s investigation, the letter concluded that there was a reasonable probability that the OxyElite Pro dietary supplements listed in the letter were adulterated and that use of or exposure to the dietary supplements would cause serious adverse health consequences or death to humans.
The letter also notified USPlabs, LLC that if the company did not initiate a voluntary recall, FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements.
On November 9, 2013, USPlabs, LLC recalled the OxyElite Pro dietary supplement products that were the subject of FDA’s November 6, 2013, letter. On November 19, 2013, USPlabs, LLC expanded the recall to include another flavor of one of the products. The products involved in the recall include:
OxyElite Pro Super Thermo capsules
- 2 count capsules UPC #094922417275
- 10 count capsules UPC #094922417251
- 10 count capsules UPC #094922417268
- 21 count capsules UPC #094922426604
- 90 count capsules UPC #094922395573
- 90 count capsules "Pink label" UPC #094922447906
- 180 count capsules UPC #094922447852
OxyElite Pro Ultra-Intense Thermo capsules
- 3 count capsules UPC #094922447883
- 3 count capsules UPC #094922447876
- 90 count capsules UPC #094922395627
- 180 count capsules UPC #094922447869
OxyElite Pro Super Thermo Powder
- Fruit Punch 0.15 oz UPC #094922417237
- Fruit Punch 0.15 oz UPC #094922447517
- Fruit Punch 4.6 oz UPC #094922426369
- Fruit Punch 5 oz. UPC #094922447487
- Blue Raspberry 4.6 oz UPC #094922426376
- Grape Bubblegum 4.6 oz UPC #094922447500
- Green Apple 4.6 oz. UPC #094922426499
- Raspberry Lemonade 4.6 oz. UPC #094922447494
This second annual report required by FSMA section 206 provides information for FY 2014. It outlines the mandatory recall activities undertaken by FDA during that time period.
 Infant formula recalls are conducted under sections 412(e), (f), and (g) of the FD&C Act. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIVFood/
 Specifically, section 423(a) of the FD&C Act provides for FDA to take action where “the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.” (21 U.S.C. 350l)
 FDA used the mandatory recall authority granted by FSMA for the first time in 2013. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm382490.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374395.htm; http://www.fda.gov/forconsumers/consumerupdates/ucm374742.htm; and http://www.fda.gov/forconsumers/consumerupdates/ucm379571.htm#1