Consumer Protection by the Food and Drug Administration
The Food and Drug Administration (FDA) has for a long time, had a mandate and legal obligation to protect consumers. The agency protects consumers through the control of the various industries it regulates, and through the various products, it governs. The FDA uses regulation inspection of products to ensure that they are safe and effective for the consumer. Any product that does not meet the necessary standards, its production stopped, and products in the market recalled until the realization of health and safety standards. Of interest for this research, is the recall and ban of chocolates, bird food, and carrots from the market in the last year. The recall of the products results from undeclaring of allergens, nutritional values, and salmonella contamination.
The FDA on first of November 2012 recalled and seized carrots supplied by Bolthouse Farms due to salmonella contamination for the 16-ounce carrot chips. This recall follows a routine sampling event, on the 22 October 2012, by the North Carolina Health officer. The officer had notified the company on the 31 October 2012, on the discovery of salmonella bacteria in a single 16-ounce bag of carrots (FDA 1). However, the company has not yet received any complaints about consumer illness on related products. This led to a recall and seizure of 5,600 cases of the 16-ounce bag of carrot chips from the U.S. and Canada markets. This is a significant consumer protection issue since the FDA has charge over the testing for salmonella species in animal food that comes in direct contact with humans, and human food. The FDA under section 402(1) (1) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 342(a) (1)), is to declare food adulterated is it contains any poisonous substance that can render it injurious to the health of consumers (FDA 1). Further, under the references (Refs. 1, 2 and 3), the FDA can take enforcement action where food has tested positive for salmonella.
The second issue concerns undeclared allergens in organic dark, milk, dark, and trail mix chocolates made by the Tropical Valley Foods. The FDA seized and injunction of the company for its products. This is because there was an error on its labels for the organic dark, milk, dark, and trail mix chocolates that were on sale in bulk quantity. The FDA found this error a violation of the Food Allergens Labeling regulation of 2008, in which company’s must register a notice, and label food to educate consumers on which products to avoid (FDA 1). The goal of this regulation is to prevent serious health consequences caused by food allergies in consumers that may consumer products without allergen labels. For Tropical Valley Foods, the FDA found that the company had failed to label its chocolates on several food allergens. The FDA found the products with undeclared wheat, tree nuts, soy, in its organic chocolates with hazelnuts, macadamias, pecans, Brazil nuts, goji mix, and cranberries (FDA 1). This was a serious offence since the different chocolate mixes had a variety of nuts and berries like coconut, orange berries, blueberries, walnuts, cashew nuts, apricots, and quinoa among others. The FDA seized the products though they were also on shipment to U.S. cities, towns, and states, and to various countries like Hong Kong, Quebec City, and Dubai in the U.A.E.
The third consumer protection issue deals with the nutritional values on select bird foods from ZuPreem. The ban issuance was on the 27 September 2012, for bird foods that had fruit flavors for large and medium birds for date codes 11/30/13 and 11/13 (FDA 1). The products ban was due to exceeding levels of calcium, high vitamin D, low phosphorus, concentrations leading to a significant health risk for the animals. The inspection reveals that the consumption of the foods can make the birds sick, and in some instances be fatal. Symptoms of effects of these levels entail water consumption, decreased appetite, and watery droppings (FDA 1). The seizure and ban due to the FDA’s FFDCA regulation for ingredients and additives in animal feeds. To the FFDCA, any substance added or expected as a food additive directly or indirectly should be meet the food additive regulation. The FDA has given the approved food additives and substances according to their amounts in 21 CFR 573 and 579 and for substances considered “Generally Recognized as Safe for the Use” (GRAS) in 21 CFR 582 and 584 (FDA 1). Acceptable additives and ingredients by the FDA are also within the “Association of American Feed Control Officials (AAFCO),” that regulates the production and additive content in animal feed including pet food (FDA 1). The nutrients added in ZuPreem Fruit Blend bird food are too high or too low of the fore-mentioned nutrients for the net weights of 2 Lbs, 3.5 Lbs, 12 lbs, 17.5 lbs, and 35 lbs.
Several public interest issues required protection in the three consumer protection issues and the legal actions taken by the FDA. The seizure due to un-declaration of allergens is ideally to protect the public from accidental allergic reactions and poisoning by ingredients (FDA 1). The FDA recognizes that different people suffer from different levels of allergic reactions to different additives and ingredients in products. For this reason, the agency requires industries and companies to declare each ingredient and additive added to food to prevent serious health consequences resulting from food allergies. This is essential since each year millions have allergic reactions. Though most foods cause mild and minor allergic reaction, there are several food allergies that are severe and can be life threatening (FDA 1). Moreover, individual’s reacts differently to different types of food, the FDA has the authorization to ensure that food industries label their products with each ingredient and additive used. In addition, there are no cures for food allergies. Therefore, the only management strategy for allergies is strict avoidance. Strict avoidance is only possible if food manufacturers label their products (FDA 1). For this reason, the oversight by the company in meeting industrial standards for labeling ingredients, additives, and allergens was a violation that mandated its injunction.
The FDA has the legal mandate to seize, injunction and prosecute any company or persons distributing adulterated food that contains poisonous or deleterious substance. Under this mandate, the FDA is responsible for the testing procedure of salmonella species in animal foods that are in direct contact to humans or human foods. The FDA has the responsibility of conducting regular testing on foods that fall into these categories and determine which salmonella species in the food can render it injurious to the health of humans (FDA 1). The FDA has the mandate to take legal action when salmonella species are detectable in these foods under the FD & C Act 21 §§ 332, 333, and 334, sections 302, 303, and 304 (FDA 1). This action is necessary since salmonella cause serious and fatal infections in children, frail and the elderly or those with weak immune systems. Healthy people who take food contaminated with salmonella suffer from diarrhea, fever, vomiting, nausea, and abdominal pain. Salmonella in the blood stream can cause severe illnesses like arterial infections, arthritis, and endocarditis.
There has been public interest in the area of nutrition and the provision of nutritional information on food and animal food. This is due to the increasing challenge in food safety, animal health, and nutrition activities associated with shifts in consumer expectation and science and technology advances. The need for nutrition and nutritional information on food is due to the rise of animal and human food borne illnesses that have a substantial effect on public health. This has caused the increase consumer expectation in the government’s regulation, in food safety (FDA 1). The key goal of the FDA in the regulation on animal food ingredient and additives program is the advancing of nutrition, food safety, and animal health.
I believe the steps taken in the three consumer protection situations are ethical and necessary in securing the public interest. This is because recalls are the corrective responsibility of companies that take an interest in protecting their consumers from the adverse effects of potential contamination, adulteration, and misbranded goods. The notice to Bolthouse farm to recall its 16-ounce bag of carrots as a voluntary action is the prerogative of the FDA to request the company to do so. The move is an advantage for the company since the cost of a recall is cheaper than the cost of retrieval of products from the market, and the covering of liability insurance to regain consumer trust. The FDA has the regal mandate and ethical responsibility to protect the public health interest from undeclared ingredients and additives in products. The seizure and ban action on goods is necessary since the FDA does not consider the issuance of waning letters to companies as the final action. The FDA has the legal mandate to warn companies not to market and distribute products whose ingredients, additives, and nutritional value information are not on the labels. Failure to do this warrants a recall, a ban, seizure or an injunction on the company. The requirement for public health safety, the recall, ban, and seizure of the products was a welcome move. For consumers who have allergies of nuts and soy products, the FDA’s action gives them power of information on products to avoid due to allergens. The public feels that the FDA in each case was ethically correct as it took actions to protect the health and safety of Americans and their pets.
Recalls, bans, seizures, and injunctions have positive and negative effects on companies involved. These actions will make the three companies incur costs in recalling, stopping manufacturer, and distribution of products within a certain batch line affected by the FDA’s inspection. Costs also arise from preparing and putting new labels on products, re-advertising, and regaining of consumer confidence. The company with an injunction has legal costs, penalty costs that may arise from a court ruling. For Tropical Valley Foods, these costs are high given that it also exports its chocolates to Dubai and Hong Kong. On the other hand, recalls increase consumer confidence in a company and its products since it indicates the company’s commitment to ensuring the safety and health of its consumers.
Work Cited
FDA. Recalls, Market Withdrawals & Safety Alerts. Food and Drug Administration, 1 November 2012. http://www.fda.gov/Safety/Recalls/default.htm. 3 November 2012.
