Year in Review—Top 5 (well more than 5) Highlights of FDA Accomplishments and FTC in 2014. Here are just a few top accomplishments in food and drug law in 2014. Last year, the question posed was whether the United States really needs an “FDA”. The role and mission of FDA has been debated for years. The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Ebola, Power Morcellators, Food Safety Modernization Act Supplemental Proposed Rules, Tobacco Enforcement, Calorie Disclosure Rules, Criminal Liability, Sunscreen Innovation Act and Diet Products….just to name a few.
Norm Thompson Outfitters and Wacoal America Settle FTC Charges Over Weight-Loss Claims The Federal Trade Commission approved two final orders settling charges that two companies, Norm Thompson Outfitters. Inc., and Wacoal America, Inc., misled consumers regarding the ability of their caffeine-infused shapewear undergarments to reshape the wearer’s body and reduce cellulite. According to the FTC’s complaints, the two companies’ marketing claims for their caffeine-infused products were false and not substantiated by scientific evidence. The products, made with Lytess brand fabrics, were sold via mail order and on the company’s Norm Thompson Outfitters, Sahalie, Body Solutions, and Body Belle websites. FTC alleged that the company made claims that wearing its shapewear would eliminate or substantially reduce cellulite; reduce the wearer’s hip measurements by up to two inches and their thigh measurements by one inch; and reduce thigh and hip measurements “without any effort.” The complaint against Wacoal America contained similar allegations. It charged that the company’s iPants supposedly slimmed the body and reduced cellulite. Specifically, the company made false and unsubstantiated claims that wearing iPants would: substantially reduce cellulite; cause a substantial reduction in the wearer’s thigh measurements; and destroy fat cells, resulting in substantial slimming. http://www.ftc.gov/enforcement/cases-proceedings/132-3095/wacoal-america-inc-matter
Currently, the standard treatment for patients infected with the Ebola virus is supportive therapy. However, that could change in the near future. NIH reported in late 2014 that an experimental vaccine to prevent Ebola virus disease proved successful in phase I clinical trial in all 20 healthy adults who received it. The vaccine is being developed by the NIH’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. Expedited review is in the works for the priority review track as well as immunity protection.The experimental drug ZMapp was used in 2014 to treat a few patients infected with Ebola; however, it is still uncertain to ascertain the effectiveness of ZMapp. According to the manufacturer, the product is in the experimental stages and clinical trials are needed. Besides Mapp Biopharmaceutical Inc., Tekmira, Chimerix and BioCryst Pharmaceuticals have therapeutic products in early developmental stages for clinical trials. See: Peter Loftus and Betsy McKay, Race is On for Ebola Drug, All St. J. A1 (Oct. 18-19 2014); Betsy McKay and Peter Loftus, Wall St. J. A7 Experimental Drugs Are Approved for Use in Fighting Ebola in West Africa (Aug. 13, 2014);http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html
POWER MORCELLATORS—Warning and Immediate Guidance
Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm
CRIMINAL FELONY CONVICTIONS
Corporate Executive Liability Food Safety—Felony Conviction Peanut Corporation of America Background and Corporate Significance The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges. Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing. Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.
CALORIE DISCLOSURE FINAL RULES
Vending Machines and Restaurant Menu Labeling Overview and link to final rules. http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm
Introduction and Quick Summary FDA released the long awaited two final rules in early December (2014) regarding caloric disclosure The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule is effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider. Food Labeling; Calorie Labeling of Articles of Food in Vending Machines Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.
Tobacco products are regulated so differently than other FDA regulated products due to the fact they are harmful yet still extensively used consumer products and are responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. The focus remains on youth and the FDA is faced for 2015 with the Ecigarette issue and deeming. CTP established the Office of Compliance and Enforcement (OCE); however, enforcement is limited as FDA’s regulatory authority is dictated by the FSPTCP. CTP has filed actions for civil monetary penalties mainly for sales to minors. A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in the imposition of a fine, termed a Civil Money Penalty. As an example of enforcement efforts, FDA filed approximately 100 civil legal actions. FDA recently sent warning letters to retailers for selling to minors. Here is the direct link:
Food Safety Modernization Act Supplemental Proposed Rules: Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Several proposed rules were issued in 2013 and now in 2014 supplemental proposed rules. Here is the direct link to the final and proposed rules.
SUNSCREEN INNOVATION ACT
Finally, the Sunscreen Innovation Act (SIA), recently signed into law in late 2014, (Public Law No: 113-195 Nov. 26, 2014) establishes a new process for the review and approval of over-the-counter sunscreen active ingredients. The SIA provides FDA with explicit, expedited deadlines for review. The SIA is a major improvement as for example some sunscreen ingredients have been under review for over ten years. Direct Link to SIA is as follows: https://www.congress.gov/bill/113th-congress/senate-bill/2141/text
FDA WISH LIST—Congressional Authorization of more resources, i.e. MONEY so FDA can effectively fulfill the mission of the FDCA.
STAKEHOLDER WISH LIST—More Clarity from FDA!
RECOMMENDATIONS—FDA and the FTC did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA” as well as an “FTC”. Hopefully though the proposed rules will be finalized in 2015 and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2015.