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The United States has a comprehensive statutory and regulatory framework that covers all stages of food production, processing, holding, distribution and marketing of food intended for human consumption.
In general, food products25 subject to the FDA's jurisdiction that are sold in the US must not be adulterated or misbranded under the FDCA.26 A food is 'adulterated' if, for example, it contains poisonous or deleterious substances that might render it injurious to health, if it is manufactured under unsanitary conditions or if it contains unsafe ingredients.27 A food is misbranded if, among other things, its labelling (due to affirmative statements or omissions) is false or misleading.28
Most domestic and foreign facilities that manufacture, process, pack or hold food must register with the FDA every two years, and failure to register can lead to refusal of an import.29 The FDA may suspend a facility registration if it determines that food manufactured, processed, packed, received or held by the facility has a reasonable probability of causing serious harm to humans.30 Registered foreign facilities must designate a US agent who lives or maintains a place of business in the US and is physically present in the US.31 Farms are exempt from registration, as are foreign facilities if food from a foreign facility undergoes further manufacturing or processing (including packaging) by another facility outside the US.32
Current good manufacturing practices (CGMPs) establish the minimum requirements for methods, equipment, facilities and controls for producing safe and wholesome food.33 Under the FDCA, as amended by the FSMA, food facilities may be subject to the following key requirements, among others.
The FDA has the authority to inspect domestic and foreign facilities that manufacture, process, pack or hold food for introduction into the US to assess compliance with CGMPs and HARPC, and might require production of records when the FDA reasonably believes that a food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.39 Indeed, the FSMA mandates that the FDA increase the frequency of inspections of food facilities, with a specific focus on foreign facilities.40 If a foreign facility refuses to permit an FDA inspection within 24 hours of the FDA's request to inspect, food from the facility will not be admitted.41
If the FDA observes violative conditions during a facility inspection, the agency will issue an FDA Form 483 to notify management. Should the FDA determine that the conditions are serious, it may issue a warning letter to the facility.42 The facility must respond to the FDA and explain how it has remedied (or will remedy) the objectionable conditions. The FDA also has other enforcement powers, including administrative detention or seizure of an article that is adulterated or misbranded, recalls (as is discussed further below), injunctions and criminal prosecutions.43
Food imported into the US generally must meet the same laws and regulations as food produced domestically. The FDA must receive prior notice of imported foods; food imported or offered for import without prior notice may be refused admission.44 Imported food products are subject to FDA review at US ports of entry, and the FDA may refuse admission of imported foods if it 'appears from the examination of such samples or otherwise' that the product:
The FDA does not certify, license or otherwise approve individual food importers, products, labels or shipments prior to importation. Under the Foreign Supplier Verification Program (FSVP) rule, importers must verify that the food they import from foreign suppliers complies with the FDCA's food safety requirements – including having processes and procedures that provide at least the same level of protection as those required under HARPC, if applicable – and is not adulterated or misbranded.46
Food products subject to USDA's jurisdiction must comply with the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA) or Egg Products Inspection Act, as applicable. Generally, the PPIA requires inspection of establishments that 'process' 'poultry products',47 and the FMIA requires inspection of establishments that 'prepare' 'meat food products'.48 Both the PPIA and the FMIA provide exemptions from federal inspection for certain types of establishments if certain criteria are met.49 Establishments that are subject to inspection must obtain a grant of inspection from FSIS and must meet associated requirements, including establishing and implementing a hazard analysis critical control point plan and sanitary standard operating procedures. There are additional requirements for imports of meat, poultry and egg products, which are limited to eligible countries and establishments in those countries that meet requirements equivalent to those established by FSIS.50
The FDA regulates most cosmetic products, which are subject to adulteration and misbranding provisions under the FDCA.51 Cosmetics are not subject to premarket review (other than for colour additives), but they must be made and packaged in sanitary facilities and be safe for their intended use.52 Although product and manufacturing facility registration is not required for cosmetics, the FDA permits voluntary registration of cosmetics establishments and voluntary filings of cosmetic product ingredients.53 Regulations restrict the use of certain ingredients that the FDA has determined are poisonous or deleterious, including mercury compounds and methylene chloride.54 The FDA may inspect cosmetic establishments to determine whether cosmetics are safe and properly labelled. If the agency identifies a violation of the FDCA, it may issue a warning letter, request that the firm conduct a recall, seize violative products, seek an injunction or seek criminal penalties.55
Under the FDCA, any substance that is intentionally added to food is a food additive and is subject to premarket review and approval by the FDA56 unless the substance is generally recognised, among qualified experts, as having been shown to be safe57 under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a 'food additive'.58 The use of a food substance may be generally recognised as safe (GRAS) either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.59 GRAS status is established through notification by an applicant to the FDA of the applicant's own conclusion that a substance is GRAS, or self-affirmation of the GRAS status of a substance without notification to the FDA. The FDA has also recognised certain substances as GRAS, as set forth in the FDA's regulations, and the agency maintains a GRAS Notice Inventory containing information regarding substances for which the FDA has received a notification.60 Packaging materials for FDA-regulated products must also comply with the FDA's food additive regulations if the packaging contains food contact substances that are reasonably expected to migrate into food.61 FSIS and the FDA have a joint ingredient approval process for meat, poultry and egg products, under which the FDA authorises safety and FSIS determines suitability and efficacy for use.62
Unlike food additives, there is no GRAS (or similar) exemption for colour additives in food. All substances that impart colour are colour additives and are subject to premarket approval unless they are used solely for a purpose other than imparting colour.63 Colour additives must comply with individual listing requirements.64 The same requirements for colour additives apply to cosmetics as well, and a cosmetic containing a colour additive that does not comply with the applicable FDA regulation is considered adulterated.65
FDA-registered food facilities generally must comply with HARPC requirements, which include creating and implementing a recall plan. Most companies have a recall policy to address situations whereby the company must voluntarily recall a product. The FDA also has the authority to issue a mandatory recall for food when the agency believes that there is a 'reasonable probability' that a food is adulterated or misbranded and its use or exposure will cause serious adverse health consequences.66 The agency must provide the responsible party with an opportunity to cease distribution and recall the food, but if the party does not institute a voluntary recall, the FDA can order the recall.67 The FDA has no authority under the FDCA to mandate a recall of a cosmetic, but the agency may request that a firm recall a product. For both food and cosmetics, once a firm initiates a recall, the FDA takes an active role in the recall process, including monitoring its progress, evaluating the health hazard presented by the product being recalled, issuing a public notification if the recalling firm is unwilling to do so and ensuring that the product is destroyed or suitably reconditioned.68 USDA does not have the authority to mandate a recall, but official establishments do have an obligation to notify FSIS of adulterated or misbranded products.69
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