Fish advice issued for women and parents of young children

Fish and shellfish provide protein, are low in saturated fat, are rich in many micronutrients, and provide certain omega-3 fatty acids. However, as a result of natural processes and human activity, fish also contain mercury in the form of methylmercury. Methylmercury can adversely affect the central nervous system, particularly the developing brain of the fetus. As a result, women who are pregnant or may become pregnant, as well as breastfeeding mothers and parents of young children, need information to make informed choices when it comes to fish that are healthy and safe to eat.

In June 2014, the FDA and the U.S. Environmental Protection Agency (EPA) jointly released a draft update to a March 2004 document entitled “What You Need to Know About Mercury in Fish and Shellfish.” The agencies have now announced revised fish advice that contains advice and supplemental questions and answers for those who want to understand the advice in greater detail. The fish advice contains a reference chart that sorts 62 types of fish into three categories:

  • Best Choices (36 types of fish)
  • Good Choices (19 types of fish)
  • Choices to avoid (7 types of fish: King mackerel, Marlin, Orange roughy, Shark, Swordfish, Tilefish (Gulf of Mexico), and Tuna (bigeye))

The reference chart suggests that women of childbearing age (16-49 years old), especially pregnant and breastfeeding women, and parents and caregivers of young children should observe the following guidelines:

  • Eat two to three servings of fish a week from the Best Choices list or one serving from the Good Choices list.
  • Eat a variety of fish.
  • Serve one to two servings of fish a week to children, starting at age two.
  • If you eat fish caught by family or friends, check for fish advisories. If there is no advisory, eat only one serving and no other fish that week.

The recommended serving size for an adult is four ounces. For children age four to seven, the recommended serving size is two ounces.

How were fish categorized?

The agencies note that they took a cautious and highly protective approach in determining which fish belonged in each category. They calculated how many servings the average pregnant woman could eat in a week using information on mercury content of each fish type from FDA’s database for commercial fish and other sources. If she could eat that fish at least three times a week, then they listed it in the “Best Choices” category. If she could eat that fish only once a week, or twice but not three times a week, then they listed it in the “Good Choices” category. If she could not eat a serving of that fish once a week, then they listed the fish in the “Choices to Avoid” category.

Why are some fish in more than one category?

The agencies explain why tuna and tilefish appear in multiple categories on the chart. Tuna comes in different types (or species), such as albacore, bigeye, and yellowfin. And because some types of tuna that are bigger or live longer tend to have higher mercury levels, they are in different categories. For example, canned light tuna is in the Best Choices category. Albacore (or white) tuna and yellowfin tuna are in the Good Choices category, and bigeye tuna is in the Choices to Avoid. In addition, fish of the same species that are caught in different geographic locations can vary in mercury content. For example, tilefish are in two categories because tilefish in the Gulf of Mexico have higher mercury levels than those in the Atlantic Ocean. As such, Gulf of Mexico tilefish is in the Choices to Avoid and Atlantic Ocean tilefish is in the Good Choices.

If some species of fish are not on the reference chart, such as mussels, that means the agencies did not have enough reliable mercury data to include it.

 

An impossible course: navigating the generic drug label delay

In May 2016, the FDA put off until 2017 a decision about a Final rule that would allow generic drug companies to update their labels with new safety information similar to their reference product counterparts. This marks the third time since the FDA proposed the rule that it has been shelved in the face of opposition from the pharmaceutical industry and some lawmakers. The delay, with major ramifications for consumers and industry alike, was initially discovered in an update to a timetable for the rule and officially appeared in a Federal Register Notice in mid-June. The development dismayed consumer groups and representatives for trial lawyers, who had urged the agency to close a legal loophole that prevents patients harmed by generic drugs from suing manufacturers.

Unlike brand-name drug makers, generic drug makers are not permitted to make changes to a drug’s label without the FDA’s approval unless the brand name drug maker makes the label change first. Instead, generic drug makers must wait for the FDA to order them to change their label. Since the passage of the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417) in 1984, known as the Hatch-Waxman Act, the FDA has approved over 8,000 generic drugs. The Hatch-Waxman Act provides an expedited approval process for generic drugs that have an identical reference listed drug (RLD). As a result, nearly nine in 10 prescriptions filled today in the U.S. are for generic drugs, yet only account for 28 percent of drug expenditures.

Two Supreme Court decisions have helped to establish the conflicting division faced by patients and drug makers regarding drug label. Under the federal Food, Drug, and Cosmetic Act (FDC Act) and the subsequent Hatch-Waxman Act amendments, a generic drug company “may not unilaterally change its labeling or change its design or formulation and cannot be required to exit the market or accept state tort liability.” Consequently, a state law is preempted in the event a generic drug manufacturer must take one of the aforementioned actions to comply with a state law duty. Thus, patients taking a generic prescription drug are unable to recover for alleged injuries from either the brand name or generic drug maker. The brand name drug maker is not liable because it did not sell the drug directly to the patient and the generic drug maker faces the “impossibility” of providing updates to the drug label without direction from the brand name drug maker.

This White Paper provides an overview of the laws and regulations establishing the foundation of drug labels. The White Paper will also discuss the impact of the Supreme Court decisions on consumers’ ability to sue a drug maker for its drug labels. Finally, this White Paper examines whether industry pressure or consumer sentiment will carry the day. As the public service announcement from the FDA attests, it may be difficult to get generic drug approval, but as follows in this White Paper, generic drug makers are also harder to sue.

Read further: “An impossible course: navigating the generic drug label delay.”

Fishy manufacturer shut down until it literally cleans up shop

An Alabama district court has permanently enjoined a seafood manufacturer from distributing adulterated and misbranded seafood products. The Department of Justice (DOJ), at the FDA’s request, filed a complaint alleging that BEK Catering LLC d/b/a Floppers Foods LLC and its owners caused food to be held under insanitary conditions. The injunction prevents the company and its owners from processing, packing, and holding fish or fishery products.

Inspection and complaint

In 2015, the FDA found that the company failed to control the risk of the growth of three different types of bacteria, and did not have adequate control over hazards that could be created by allergens and additives. The bacteria found during the inspection can cause foodborne illness, botulism, and listeriosis. The complaint noted that five different inspections beginning in 2011 revealed insanitary conditions and repeated regulatory violations.

Consent decree

The consent decree requires the company and its owners to cease operations beyond those incidental to product transport and delivery. In order to resume operations, they must notify the FDA 90 days in advance, comply with a set of remedial measures, and undergo inspection. The remedial measures include hiring an expert to ensure that operations conform with seafood hazard analysis critical control point (HACCP) and current good manufacturing practice (cGMP) regulations, all deficiencies are addressed, an employee training program is developed, and the FDA approves all changes.

OIG takes a bite at FDA’s food recalls

The FDA did not have an efficient and effective food recall initiation process to ensure the safety of the U.S. food supply, according to a highly critical Office of Inspector General (OIG) report. Specifically, the FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain and the issue required immediate attention.

The OIG recommended that the FDA update its policies and procedures to instruct its recall staff to establish set timeframes for: (1) the FDA to request that food manufacturers voluntarily recall their products; and (2) food manufacturers to initiate voluntary food recalls. The OIG audit follows a previous 2011 report titled “Review of the Food and Drug Administration’s Monitoring of Imported Food Recalls” (A-01-09-01500) that found the FDA’s food recall program was inadequate because the agency did not have the authority to require food manufacturers to recall certain foods, nor did the agency always follow its own procedures.

Recalls

Prior to the passage of the Food Safety Modernization Act (FMSA) (P.L. 111-353) in 2011, the FDA did not have the authority to require a food manufacturers to recall certain articles of food. However, the FSMA added section 423 to the Food, Drug, and Cosmetic Act (FDC Act), which gives the FDA authority to order a food manufacturer to recall food once the agency determines that (1) there is a reasonable probability that the food is adulterated or misbranded; and (2) it will cause serious adverse health consequences or death to humans or animals (known as the unwieldy SAHCODHA). To date the FDA has used its authority under FSMA twice.

The FDA relies on food manufacturers to voluntarily recall harmful articles of food. However, before issuing a mandatory food recall, the FDA provides the manufacturer an opportunity to “voluntarily” recall the product. The FDA may request the recall in a specific manner and if the firm refuses or fails to complete the recall, the agency can force the manufacturer to cease production of the food item.

Audits

The OIG selected what it termed a “judgmental” sample of 30 imported and domestic voluntary human food recalls reported to the FDA between 2012 and 2015. Although a potentially skewed sample – the OIG looked at recalls considering risk factors that included classification and length of time – the OIG noted that the FDA did not provide a timeline to the food manufacturer to adhere to in its voluntary food recall. For two recalls, specifically, the food manufacturers involved did not recall all of the potentially harmful products from market until 165 days and 81 days after the FDA became aware of the potential adulteration. The OIG partly attributed this massive delay on the FDA’s failure to have policies and procedures instructing its recall staff to establish firm deadlines.

The OIG concluded that the FDA should consider the report’s finding as the FDA continues with FSMA implementation. The FDA agreed, but the question remains to be answered whether the agency will be able to do so with continuing staffing and resource issues.