खाद्य तथा दाना बस्तुहरुमा निर्धारित न्युनतम अनिवार्य गुणस्तर

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Bacillus cereus and food poisoning

Bacillus cereus and food poisoning

Excess iodine intake and its relation with thyroid dysfunction

 

For the control of Iodine Deficiency Disorder (IDD), Universal salt Iodization (USI) was implemented. As a result of it, Nepal is heading towards iodine sufficiency however the prevalence of clinical and sub-clinical hypothyroidism is still higher.The increased prevalence of thyroid disorders can be result of iodine deficiency or excess of iodine intake. The prevalence of excess iodine intake is hiking all over the world including Nepal. A study done in 1000 patients (with 270 clinical hypothyroidism patients) showed anti-TPO (Thyroid Peroxidase) antibody positive. The study also stated that the cause of hypothyroidism in present day Nepal was chronic autoimmune thyroiditis (Hashimoto's thyroiditis). As stated earlier, the status of iodine consumption in Nepal is moving from iodine deficiency to adequate or excess, there might be higher burden of thyroid disorders in Nepal due to the increased prevalence of autoimmune thyroiditis (Pokharel, S., 2019). 

A community based cross sectional study done in Udaypur (Nepal) in primary school aged children (6 years to 12 years) showed 10% (n=20) prevalence of thyroid dysfunction (sub-clinical hypothyroidism). Majority of the participants were reported to have excess urinary iodine concentration (UIC). The sensitive marker of recent dietary iodine intake is Urinary iodine rather than thyroid dysfunction. The analysis of thyroid hormones showed 1.6% of school age children had sub-clinical hyperthyroidism.

Although any apparent clinical consequences are not resulted by excess iodine exposure, thyroid dysfunction can occur in sensitive patients with specific risk factors, including those with pre-existing thyroid disease, the elderly, fetuses and neonates. The iodine-induced hypothyroidism or hyperthyroidism could be either sub-clinical or overt, hence excess iodine exposure should be suspected. The aeitology of thyroid dysfunction in not discernible.

Besides, Iodine Global Network (IGN) has highlighted several countries around the world to be categorized as having excess iodine status in population. As per study done in school age children in 6-9 years of age, IGN has listed Nepal in excessive iodine intake country. So, this could necessitate for the revisit of iodine standard in Nepal.

फलफुलको रसको प्रस्तावित गुणस्तर

WTO SPS नोटिफिकेसनको चरणमा रहेको "फलफुलको रसको प्रस्तावित गुणस्तर " देहाय बमोजिम रहेको देखिन्छ l  (श्रोत: एस पी एस इनक्वारी पोइन्टको वेब साइट ) l  तपाइको प्रतिकृया वा सुझाब तल दिनु होला l 

Federal Inspections and Law Enforcement Tools used by FDA (US Food Regulation series: Part 5)

We have been publishing a series of posts related to US Food Regulation. We have already completed four parts of the series. The first part of the series entitled “US Food Law and Regulation Series: Part 1” was focused on the discussion of different regulatory body such as FDA, USDA/FSIS, CDC, NMFS, EPA, DHS etc. “US Food Law and Regulation Series: Part 2” described the issues related to food, dietary supplement and drug. The third part was about the "History of the regulation of dietary supplements (US Food Regulation series: Part 3). In the fourth part, we discussed on the topic of "Jurisdictional overlap between FDA and USDA (US Food Regulation series: Part 4)". 

In this post we will discuss about the "Federal Inspections and Law Enforcement Tools used by FDA".

Generally, FDA does not go to the facility for inspection on a daily basis. FDA conducts warrantless inspections generally for a special cause such as recall, adverse events, or for surveillance inspection. The regulatory work can be divided into two groups: “pre-market” and “post-market surveillance” activities.

Center for Food Safety and Applied Nutrition (CFSAN) of FDA is mainly responsible for pre market activities of food products. In addition, Center for Veterinary Medicine (CVM), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Device and Radiological Health (CDRH), and Center for Tobacco Products (CBT) are also product-oriented centers of FDA focusing on pre-market surveillance activities.

The post market surveillance activities are mainly the responsibility of Office of Regulatory Affairs (ORA). It works for all the six product-oriented centers and not only for CFSAN. Hence, it carries out investigation of drug, medical device, cosmetic, biologics, veterinary products, food, beverage, and dietary supplements. The criminal investigation part of FDA is handled by Office of Criminal Investigations (OCI). 

FDA enforcement tools

FDA uses different law enforcement tools as per Food, Drug and Cosmetic act. The most important tools are as follows:

a) Form 483

It is simply a notice of potential violations found during inspection and is issued by the inspector after facility inspection . It only contains opinion of inspectors and is not reviewed by a compliance office or other FDA officers prior to being issued.

b) Warning letters as enforcement instruments

The first enforcement tool used by FDA is a warning letter, which functions as a prior notice. This is not a statutory creature and is not mandatory. FDA can initiate formal enforcement action without warning letters.

The Form 483 and warning letters are informal enforcement actions of FDA. There are five formal enforcement actions taken by FDA: (1) seizures and administrative detentions, (2) recalls, (3) import refusals and alerts, (4) restraining order or injunctions, and (5) suspension of facility registration.

1) Seizure and administrative detentions

The decision of seizure by FDA is taken only when there is a question of safety. Seizure requires court warrant and is carried out by US Marshals. FDA is only involved indirectly. An administrative detention is less severe form of temporary action. After FSMA regulation, if FDA agents have “reason to believe food is adulterated or misbranded”, they can take temporary hold of products for 30 days to carry out investigation.

2) Recalls

Recall is one of the best known FDA enforcement actions. Recall is mainly linked with some type of outbreak of food-borne illness. Generally, recall is a voluntary action carried out by the manufacturer. After the enforcement of Food Safety Modernization Act (FSMA), FDA is authorized to force a recall without court order under certain circumstances.

3) Import Refusal and Import Alerts

Before entering the US market, products must pass through both the customs and FDA. Previously, FDA agent used to randomly inspect the containers based on their experience or previous history. Now, FDA has launched PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) system which uses a complex algorithm to determine the risk and the likelihood of violation on a particular product. The new system is an example of Risk based food import control system.

Imported products must comply with the standards. Otherwise, they can be detained, refused, returned, destroyed and even blacklisted. If the products do not comply with standards, FDA provides a notice of its decision to refuse admittance and issues FDA Import Detention Notice. The importer can provide oral testimony or submit written evidence within 10 days time frame.

The legislation states that FDA can refuse entry to a products based on the examination of samples that appears adulterated or misbranded. FDA may also issue an import alert that essentially acts as a blacklist. If a facility is on an import alert, all the shipments can be refused (detention without physical examination (DWPE)). The petition-for-removal from import alert takes a long process (may be more than a year) and must present evidence on how the violation was corrected. FSMA regulation has mandated a new rule known as Foreign Supplier Verification Program (FSVP).

Opinion Poll on FDA

Jurisdictional overlap between FDA and USDA (US Food Regulation series: Part 4)

In the previous post entitled “US Food Law and Regulation Series: Part 1”, we focused our discussion on the different regulatory body Food and Drug Administration (FDA) , US Department of Agriculture’s Food Safety Inspection Service (USDA/ FSIS), CDC, NMFS, EPA, DHS etc and their interaction in the food safety regulation. In the second part of the series entitled “US Food Law and Regulation Series: Part 2”, we tried to discuss the issues in the definition of food, dietary supplements and drug. We also discussed the concept of “intended use” and how it can have impact on the definition. In the third part of the series entitled, "History of the regulation of dietary supplements (US Food Regulation series: Part 3)", we discussed about the problems and issues of dietary supplement regulation by FDA. The era of confusion on the regulation of dietary supplements ranged from 1906 till 1994, when FDA and manufacturers faced multiple incidences of court cases due to regulatory ambiguity and differences in understanding. It demanded for a separate DSHEA act in 1994 for the regulation of dietary supplement as food. Based on the discussion, we had concluded that single food and drug control agency is not a requirement for the regulation of dietary supplement. 

This is the fourth part of the series. In this post, we will focus our discussion on the "jurisdictional overlap between FDA and USDA". Food and Drug Administration (FDA) and the US Department of Agriculture’s Food Safety Inspection Service (USDA/ FSIS) are two primary food control agencies of US. We will try to evaluate the issues and challenges of having multiple food control agencies in a country.

Food Drug & Cosmetic act is a governing act to regulate food safety in US. However, there are jurisdictional overlap between FDA and USDA/FSIS. To reduce this overlap, series of guidelines and agreements between the agencies have been formulated. In some cases, the boundary is clear, while in many cases the line is arbitrary. This has created number of problems in the history.

In general, USDA through FSIS is responsible for regulating meat, poultry and egg products. However, there are areas of overlaps and confusion. Let’s take some examples:

1. A sausage product is regulated by both the FDA and USDA. The meat filling is regulated by USDA and the casing containing meat of no nutritional value is regulated by FDA.

2. The shelled eggs, chicken feed and egg labeling is regulated by FDA, while the egg products (liquid, dehydrated, frozen etc), the laying facilities, grading of eggs are regulated by USDA.

We can imagine the level of confusion it can create. A single food safety agency can provide a more cohesive approach. Facilities regulated by both the agencies are having difficulties fulfilling the requirements. For example, a chicken tomato soup making facility will be inspected by both the agencies. It creates confusion and overlapping of authorities during inspection, enforcement actions and carrying out the compliance programs.

Let’s try to compare the FDA and USDA jurisdiction  in the following table.

FDA jurisdiction	USDA jurisdiction
All non-specified red meats (bison, rabbits, game animals, zoo animals and all members of the deer family including elk (wapiti) and moose)), all non-specified birds including wild turkeys, wild ducks, and wild geese	Cattle, sheep, swine, goats, horses, mules or other equines, including their carcasses and parts, turkeys, ducks, geese and guineas, domesticated chicken, turkey, duck, goose or guinea.
Products with 3 % or less raw meat; less than 2% cooked meat or other portions of the carcass; or less than 30 % fat, tallow or meat extract, alone or in combination	Products containing greater than 3% raw meat; 2% or more cooked meat or other portions of the carcass; or 30% or more fat, tallow or meat extract, alone or in combination
Products containing less than 2% cooked poultry meat; less than 10% cooked poultry skins, giblets, fat and poultry meat (limited to less than 2%) in any combination	Products containing 2% or more cooked poultry; more than 10% cooked poultry skins, giblets, fat and poultry meat in any combination
Closed-face sandwiches	Open-face sandwiches
Shell eggs and egg containing products that do not meet USDA’s definition of “egg product.”	Dried, frozen, or liquid eggs, with or without added ingredients, but has many exceptions. The following products, among others, are exempted as not being egg products: freeze-dried products, imitation egg products, egg substitutes, dietary foods, dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, sandwiches containing eggs or egg products, balut and other similar ethnic delicacies. Products that do not fall under the definition, such as egg substitutes and cooked products, are under FDA jurisdiction
Egg processing plants (egg washing, sorting, packing)	Egg products processing plants (egg breaking and pasteurizing operations)
Cheese pizza, onion and mushroom pizza, meat flavored spaghetti sauce (less than 3 % red meat), meat flavored spaghetti sauce with mushrooms, (2% meat), pork and beans, sliced egg sandwich (closed-face), frozen fish dinner, rabbit stew, shrimp-flavored instant noodles, venison jerky, buffalo burgers, alligator nuggets, noodle soup chicken flavor	Pepperoni pizza, meat-lovers stuffed crust pizza, meat sauces (3% red meat or more), spaghetti sauce with meat balls, open-faced roast beef sandwich, hot dogs, corn dogs, beef/vegetable pot pie, Chicken sandwich (open face), chicken noodle soup

Panel Discussion on FDA organized by NEFOSTA

Is it time to revisit the standard of "Iodised salt"?

A paragraph from the recently published article: 

"WHO/UNICEF/IGN recommends that the iodine status of populations be based on the mUIC. It has been further designated that an optimal iodine intake is where a mUIC in school aged children (SAC) is in the range of 100–299 ug/L and excessive if the mUIC >300 ug/L (UNICEF, 2015). These levels are not as well defined for women of reproductive age, but for pregnant women, the optimal range is 150–249 ug/L, whereas the iodine intake is considered to be above requirements when the mUIC is between 250 and 499 ug/L and excessive >500 ug/L (WHO, 2013). With these criteria in mind, the 2016 survey shows that at the national level, SAC are currently classified in the “excessive” range, whereas pregnant women and women of child bearing age would be classified as “adequate” and “more than adequate,” respectively. Looking at the stratified results for several subgroups in the population, among the 34 strata listed, 19 (56%) were classified as excessive for SAC. Iodine intake was high in the central and western regions, in the Terai, and among a number of ethnic groups including the poorer Terai Janajati. For pregnant women, there were no strata with mUIC >500, but again, the sample size was small rendering these estimates imprecise. In addition, the assessment of iodine content of salt showed that mean iodine content for all salt samples was 44.1 ppm, and that 67.5% were >40 ppm—well above the expected level at the retail (30 ppm) and household (15 ppm) levels. The standards are based on an average per capita consumption of 10-g salt per day, so an iodine content this high will provide more than three times the daily requirement. These findings suggest that the current standard, combined with marked increase in use of a refined packaged product, may require an adjustment of the standard. "

WHO International Health Regulations Capacity Assessment

PDF Document "WHO BENCHMARKS for International Health Regulations (IHR) Capacities".

Please note that the chapter 5 of this document is specifically related to "Food Safety". Other chapters such as Antimicrobial resistance, Zoonotic disease, WASH, Public health etc are also directly or indirectly linked with food safety.  It shows the importance of food safety in the health sector. Food Safety is a shared responsibility. Government of Nepal and Ministry of Health and Population has got attention on the "National Food Control System" of Nepal. Let's hope that we can use this opportunity (or may be challenge?) for the betterment of all the Food Safety Professionals.

Does anybody have the evaluation report based on this benchmark? Where do we stand in this benchmark? It could be interesting to read and discuss further.

History of the regulation of dietary supplements (US Food Regulation series: Part 3)

In the previous post entitled “US Food Law and Regulation Series: Part 1”, we focused our discussion on the different regulatory body FDA, USDA, CDC, NMFS, EPA, DHS etc and their interaction in the food safety regulation. In the second part of the series entitled “US Food Law and Regulation Series: Part 2”, we tried to discuss the issues in the definition of food, dietary supplements and drug. We also discussed the concept of “intended use” and how it can have impact on the definition.

This is the third part of the series. In this post, we will shortly discuss the EU and Japanese system of regulation of dietary supplement. However, our main focus will be the regulatory mechanism of dietary supplement in USA. The history of FDA with dietary supplement is the learning for the entire world. The issues and challenges faced by FDA, court decisions, background and the driving force for the development of a separate dietary supplement regulation will be discussed chronologically.

Let’s start with EU and Japanese system.

European Food Safety Authority uses a term food supplements. European Union (EU) has analogous regulatory system compared to US. The main dietary regulation is found in 2002 EU directive, Directive 2002/46/EC. It has a list of permitted vitamin and mineral components for specific intended uses. The regulation 1924/2006 related to nutrition and health claims was adopted in 2006 and it demands the verification for substantiation and approval for the claims.

In Japan, all the supplements are treated as food. Yet it offers the most restrictive regulation of dietary supplements. Supplements are categorized into 4 categories: Food for special dietary uses; Food for specified health uses; Health foods; and Health foods with nutrient function claims. The structure/function claims are not allowed and only the few health claims are allowed in certain supplements.

The details of the discussion on EU and Japanese regulatory systems have been skipped for the moment to focus our discussion on history of regulation of dietary supplement in USA.

Regulation of dietary supplement by US FDA
Let's start our discussion chronologically starting form the beginning of 19th century.

In the past, only a small number of ingredients (usually common food constituents) were used as supplement. Cod liver oil having vitamins A and D is probably the first dietary supplement in USA. The 1906 Act provided the first distinction between food and drug, however the regulation of both products were identical. The classification was mainly based on active molecules and the packaging claim.

With increasing public interest in vitamin supplements, FDA started working in the vitamin claims and established a Vitamin Division in 1935. It also started working on new ingredients/ compounds with claimed health benefits. FDA filed a criminal case against a vitamin product containing milk, sugar, wheat starch and vitamins with health claims of curing high blood pressure, low blood pressure, dropsy, toxic goiter, and heart disease. It was probably the first attempt to take legal action against the vitamin product with disease claims in USA. The FDA experience with such case did influence and shape the upcoming regulation in the field of dietary supplement. The 1938 act provided authority to FDA for the regulation of supplement type products having labeling of “food for special dietary uses” under the misbranding provisions. Three groups of foods were initially focused in the regulation under the 1938 act: (1) “staple foods fortified with vitamins and minerals” were regulated with standards of identities, limits on the amount of nutritional ingredients and barring any health claims; (2) “foods for special dietary uses” (e.g. infant foods and foods for diabetics ); (3) dietary supplements were regulated either as conventional food or food for special dietary purposes. In the early days, parenteral supplements, despite not having labeling of disease claims, were exclusively regulated as drugs. Nevertheless, the products with an intended use to supplement the daily diet were regulated as foods.

This approach didn’t work well to regulate claims on vitamins, minerals and dietary supplements, as regulations for special dietary food was not designed in that way. In a series of court case between FDA and different manufacturers (such as Nutrilite, Abbott, Dextra, Vitasafe, Nutrilab) the concept and classification of dietary supplement emerged. Among them the most significant case was the one that of Nutrilab. The court decided that “intended use” could be the greatest tool to classify supplements. FDA was allowed to classify the product with alleged disease claims or medicinal use as drugs, and should pass through premarket clearance. On the other hand, FDA should regulate the dietary supplements without claims or with nutritional claims as food.

FDA attempted to issue a separate regulation for dietary supplements in 1962 with a set dosage levels of supplements. FDA proposed to permit a single nutrient dietary supplement with levels close to US Recommended Daily Allowance (RDA), while limiting the number of multivitamin and mineral products. The proposed regulation was to classify the “high potency” dietary supplements as drug, which created a series of spark and outcry. FDA eventually needed to drop its proposal. Afterwards, Congress attempted to regulate vitamins and minerals with therapeutic claims using “Vitamin and Mineral Amendment of 1976”. This was the first specific attempt to address dietary supplements by stopping the FDA to regulate threshold based “high potency” dietary supplement as drug. However, the scope of the legislation was narrow for regulating different dietary supplement products. FDA continued its attempt to regulate number of supplements using drug regulations.

In 1990, nutrient content and other claims for food were established in Nutritional Labeling and Education Act (NELA). It established the concept of nutritional labeling. NELA made it mandatory to declare any vitamin and mineral supplementation in the label. It also opened the door for health claims for dietary supplements to make certain claims about the benefits of nutrients it contained. It allowed the established claims related to the reduced risk of disease or health conditions. However, a general dietary guidance (such as fruits and vegetables as part of healthy diet) is not considered a health claim. FDA was authorized to review and approve the health claims using the criteria set by NLEA. FDA needed to conduct an exhaustive review of scientific literatures to obtain “significant scientific agreement” on the health claims. Only the FDA approved health claims were allowed.

The history of L-tryptophan regulation by FDA should be remembered here. FDA was concerned with an supplement ingredient L-tryptophan (an amino acid) over the adverse health effect of eosinophilla myalgia syndrome. FDA issued a consumer advisory warning to the public about that supplement and established a task force to examine. That task force recommended the FDA to regulate that supplement as drug, without considering the possibility of health claims under NELA. It was ultimately considered an aggressive enforcement approach of FDA by different experts and law makers.

The era of confusion on the regulation of dietary supplements ranged from 1906 till 1994. A rapidly growing market with unscrupulous claims of dietary supplements was an increasing challenge for FDA. Even judiciary struggled to develop consistent interpretation of the act in the field of dietary supplements. It ultimately demanded for the Dietary Supplement Health and Education Act (DSHEA) of 1994. Congress passed DSHEA to restrict FDA ability to impose unnecessary control on dietary supplements, because of unrealistic and aggressive enforcement of FDA in the case of L-tryptophan case. Enactment of DSHEA was a ground breaking step in the regulation of dietary supplement. It established a framework for new Good Manufacturing Practices (GMPs) for the dietary supplement industries.

ISO/IEC 17025

Please find the document "ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories" .

US Food Law and Regulation Series: Part 2

In the first part, we discussed different agencies/organizations involved in the regulation of food safety in US. Basically we found that FDA and FSIS were the primary agencies and NFMS, EPA, CDS, DHS, APHIS etc were secondary agencies in terms of the responsibilities of food safety in USA.  Click here to read the Part 1 of the series.
In this post, we will try to discuss on the FDA jurisdiction and authority.
The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In general, there are 4 categories of products regulated by US FDA: food & dietary supplement, cosmetic, drug and device. The fifth category is those not regulated by FDA. This classification is the heart of all the enforcement decision. Hence, let’s try to discuss and understand this classification better in both technical and legal terms.
The legal definition of food, food additive, dietary supplement and drug are as follows:

------------------------------- you can skip these legal definition, if you are not interested ----------------
"Section 201 (f) “food”: “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article"
"Section 201(s) “food additive”: “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or(2) a pesticide chemical; or(3) a color additive; or(4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph 4 pursuant to this Act [enacted Sept. 6, 1958], the Poultry Products Inspection Act (21 U.S.C. 451 and the following) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 and the following);(5) a new animal drug; or(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement"
"Section 201 (ff) “Dietary Supplement”: “dietary supplement”—(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:(A) a vitamin;(B) a mineral;(C) an herb or other botanical;(D) an amino acid;(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);(2) means a product that—(A) (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or(ii) complies with section 411(c)(1)(B)(ii);(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and(C) is labeled as a dietary supplement; and(3) does—(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and(B) not include—(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this ActExcept for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act"
"Section 201(g) (1)(c) : the term ‘drug’ means … (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals…(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Also called the “food exception,” it is the most cited defense to a drug classification of a food-based product claiming some drug-like effect."
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There were multiple incidences of ambiguity in the classification of product as food, food supplement and drug. There were multiple disputes between FDA and manufacturer in the product classification and for deciding the regulatory requirements. Such issues were challenged in the US court.
This confusion and ambiguity exists even in US where a single Food and Drug Administration (FDA) exist. In number of cases, the federal court reached a conclusion that the definitions are overlapping and the determination of classification of product only based on definition is very difficult without taking into account the “intended use” concept. It means, if a product is making "drug-like claims (such as prevention or cure of disease)" on labeling, we can slide the classification from food towards drug, while with "nutrition and health claims within the domain of food" can be considered as a food product. For example, honey can appropriately be classified as food, as it is often eaten plain or added as a sweetener to other foods. However, if the label states therapeutic/ disease claims (prevention or treatment of disease) such as “calming an upset stomach”, it falls under the drug definition of section 201(g)(1)(c)(B). On other hand, if the label states “nutrition claims or structure-function claim” such as “honey slows the absorption of trans fats”, it is considered in the food category. Therefore, a food supplement with nutrition and health claims cannot be classified in a drug category, however, those having drug-like claims (such as prevention or cure of disease) will clearly fall in the drug category for regulation. The court also mentioned that no product normally used as a food can be classified as a drug. Classification is the most critical issue as it determines the appropriate regulatory burden in the product as shown in the figure. The regulatory requirement for drug and medical device is significantly more burdensome than for other classes of products.

US Food Law and Regulation Series: Part 1

This is a first part of the US food regulation series. We will try to understand the US food safety regulation mechanism and the role of relevant organizations such as FDA, FSIS etc. This series will be continued in future.
Let me start with federalism and the structure of US Government. The USA is a union of several sovereign States defined in the US Constitution. The framework for federal regulation, interstate commerce, individual and corporate freedoms and liberties etc are defined in the constitution. It establishes specific powers to the federal government and the States, based on the concept of federalism.

Food and Drug Administration (FDA) and the US Department of Agriculture’s Food Safety Inspection Service (FSIS) are two primary food agencies of US regulating food safety. Other agencies or divisions such as National Marine Fisheries Services (NFMS), the Environmental Protection Agency (EPA), and the Center for Disease Control and Prevention (CDC), Department of Homeland Security (DHS) take some minor responsibility for food safety as shown in figure. The USDA’s Animal and Plant Health Inspection Service (APHIS) also helps in food safety indirectly by working to protect plant and animal resources from pests and diseases like bovine spongiform encephalopathy (BSE or “mad cow” disease).

The FDA is under the department of health and human services. FDA has following different divisions.
Department of Health and Human Services
· Food and Drug Administration

• Office of the Commissioner
• Office of Operations
• Office of Policy, Planning, Legislation, and Analysis
• Office of Medical Products and Tobacco
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Oncology Center of Excellence (OCE)
• Center for Tobacco Products (CTP)
• Office of Foods and Veterinary Medicine
• Center for Veterinary Medicine (CVM)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Office of Global Regulatory Operations and Policy (GO)
• National Center for Toxicological Research (NCTR)
• Office of Regulatory Affairs

Organization structure concept described in National Food Safety Policy 2076

नेपाल सरकार मन्त्रिपरिषदको मिति २०७६/०३/०८ को निर्णयबाट स्वीकृत भएको "खाद्य स्वच्छता नीति, २०७६" मा खाद्य स्वच्छता नियमन सम्बन्धमा  देहाय बमोजीम संस्थागत संरचनाको परिकल्पना उल्लेख भएको देखिन्छ  ।

"१२. संस्थागत संरचना

कृषि विकास रणनीति, २०७२ मा खाद्य स्वच्छता प्राधिकरण गठन गर्ने कुरा उल्लेख भए तापनि आवश्यक पूर्वाधारहरूको संरचना, जोखिममा आधारित निरीक्षण प्रक्रिया एवम् प्रत्यायन प्राप्त प्रयोगशालाको विकास नभई उल्लिखित प्राधिकरणको स्थापना र गठन सम्भव नभएकाले क्रमिक रूपमा नियामक निकायहरूको विकास र क्षेत्र विस्तार हुंदै सक्षम भइसकेपछि खाद्य स्वच्छता तथा गुण नियन्त्रण प्राधिकरणमा रूपान्तरित गरिनेछ । खाद्य स्वच्छता तथा गुण नियन्त्रण प्राधिकरण गठन नभएसम्म सबै नियमनकारी निकायहरूबीच आपसी सद्भाव तथा समझदारी सृजना गर्न, खाद्य नियमन पद्धतिलाई एक अर्काका कामहरूमा परिपूरक एवम् पारस्परिक सहभागितामा आबद्ध गरी प्रभावकारी कार्यान्वयन पद्धतिको विकास गर्न, खाद्य क्षेत्रमा पर्याप्त सक्षम र सक्रिय जनशक्ति, कर्मचारीहरू र नियमनकारी संरचनाहरूको उपयोग एवम् तिनलाई मितव्ययी बनाउन तथा अनावश्यक दोहोरोपन एवम् नियमनकारी निकायहरूबीच अस्पष्टता अन्त्य गर्न हाललाई एक अन्तर मन्त्रालय खाद्य स्वच्छता निर्देशन समितिको स्थापना गर्न कानुनी व्यवस्था गरिनेछ ।

खाद्य स्वच्छता तथा गुणस्तर व्यवस्थापन सम्बन्धमा केन्द्रीय स्तरमा देहाय बमोजिमका कार्यहरू गरिनेछन ः

क) खाद्य स्वच्छता तथा गुणस्तर कायम गर्न खाद्य प्रविधि तथा गुण नियन्त्रण विभागको प्रमुख भूमिका हुनेछ ।

ख) कृषि विभाग तथा पशु सेवा विभागको परिपूरक एवम् सहयोगात्मक भूमिका हुनेछ ।

ग) स्वास्थ्य सेवा विभाग, वाणिज्य, आपूर्ति तथा उपभोक्ता संरक्षण विभाग र भन्सार विभागको सहयोगी भूमिका हुनेछ ।

खाद्य स्वच्छता नीति कार्यान्वयन गर्ने जिम्मेवार निकाय खाद्य प्रविधि तथा गुण नियन्त्रण विभागलाई अन्य धेरै संघ–संस्थाहरूसंगको सहकार्यको आवश्यकता पर्ने हुंदा आवश्यक सरोकारवालाहरूको भूमिकाबारे अनुसूची १ मा प्रस्तुत गरिएको छ ।"

खाद्य स्वच्छता नीति, २०७६ को पूर्ण पाठको लागि यहाँ हेर्नुहोस ।

Dietary Supplement issues in National Food Safety Policy of Nepal

The issue of dietary supplements, nutraceuticals, food supplement and functional foods has been addressed in the "National Food Safety Policy 2076" approved from Nepal Government in 2076/03/08. 

The roles and the responsibilities of the different organisations have been clearly mentioned in the approved policy. Let's read the highlighted text below:

Please read "National Food Safety Policy 2076" for details.

Vitamin and mineral requirements in human nutrition

PDF Document: "WHO (2004): Vitamin and mineral requirements in human nutrition"

 

 

WHO SEARO Framework for action on Food Safety

The South-East Asia is home to one quarter of the world’s population. According to WHO statistics, “the burden of foodborne diseases in the region is the second highest among all WHO regions, accounting for 150 million illnesses, 175 000 deaths, and 12 million disability-adjusted life-years (DALYs) in 2010”. The comparison of global burden of foodborne disease by enteric hazards on different WHO regions is shown in figure.

 (WHO, 2015)

To fight with such challenges, WHO South-East Asia Regional Office has recently published a framework for action on food safety for this region. The framework has identified 7 important components of national food control system. The following strategic actions have been proposed under different components as described below:

"Component 1: Policy and legal framework

Strategic actions:
1. Develop, review and regularly update food safety policies, legislations and standards to include all requirements of a risk-based food control system, to address current emerging
issues, and to harmonize food legislations across various competent authorities in line with international requirements such as Codex Alimentarius Commission, the World Trade Organization the World Organisation for Animal Health (OIE), Sanitary and Phytosanitary (WTO SPS) agreement and Technical Barriers to Trade (TBT) measures, where applicable.
2. Disseminate food safety policies, regulations and standards through various means, including online tools such as official websites.

Component 2: Control management

Strategic actions:
Facilitate cross-sectoral coordination, integration of food control services and synergy in actions at the national and sub-national levels to achieve common food safety goals.

Component 3: Risk-based food inspection

Strategic actions:
1. Develop and implement risk-based inspection across the food chain.
2. Allocate adequate resources for inspection including appropriate inspection tools and sampling plans.
3. Establish a monitoring programme for specific contaminants and residues.
4. Develop guidance documents and tools for food business operators (FBOs) to develop food safety management systems such as good hygienic practices (GHP), good manufacturing practices (GMP), hazards analysis and critical control points (HACCP), traceability, recall, labelling, and food fraud vulnerability assessment and mitigation plan, and encourage them to conduct self-audit programmes.

Component 4: Data and information to support evidence-based control measures

Strategic actions:
1. Establish a national integrated data management system (data collection, central database, quality monitoring), conduct structured and timely data analysis for risk assessment, set standards, prioritize and participate in regional and international data sharing, e.g. Codex, global environment monitoring system (GEMS-food database).
2. Encourage utilization of information for evidence-based policy advocacy and decision making.
3. Collect and share data on FBD outbreaks through national disease surveillance systems (EBS and IBS).
4. Develop platforms for collaboration with academicians and researchers in conducting scientific studies to support risk assessment on food safety, conduct specific research to test hypotheses generated from FBD surveillance, and provide and sustain continued education for professional development of food safety officials.

Component 5: Data and information to support evidence-based control measures

Strategic actions:
1. Establish or have access to adequate laboratory services, including reference laboratories and satellite/mobile laboratory units equipped with reliable rapid test kits for on-thespot testing.
2. Develop and implement a laboratory network at the national and sub-national levels, collaborate with regional reference laboratories to improve efficiency and cost– effectiveness.
3. Develop and implement a sample management system.
4. Ensure that internal and external quality control/assurance systems (proficiency testing) for food testing are in place, including accreditation, where necessary.

Component 6: Preparedness and response to food safety emergencies

Strategic actions:
1. Develop, update and test cross-sectoral preparedness and response plans for food safety emergencies in line with the One Health approach and integrated with the NAPHS.
2. Use the INFOSAN community website/network to communicate on food safety incidents or emergencies and participate in identification/traceability/recall of implicated products.
3. Build or strengthen capacity to conduct investigation on FBD outbreaks and food safety events using the One Health approach.

Component 7: Food safety communications and education

Strategic actions:
1. Develop education and capacity-building programmes on food safety for professionals through various means, including online training.
2. Establish guidance documents for FBOs to manage food safety risks in line with national requirements.
3. Identify training needs and provide assistance/encouragement to FBOs to deliver continuous education and communication on food safety for all personnel involved in the food chain.
4. Provide food safety awareness and training for food handlers/street food vendors/ small-medium enterprises (SMEs) to improve hygiene and food safety practices.
5. Develop and implement consumer awareness programmes promoting food hygiene practices, food labelling, healthy diets, food allergy prevention, including the “Five keys for safer food” through various means such as online communication channels
(e.g. official websites and social media) as per country context and needs of the target population.
6. Review and update available food safety information regularly.
7. Design and provide tailored and specific food safety information targeting vulnerable populations (infants, pregnant and lactating mothers, the elderly and immunocompromised).
8. Develop appropriate mechanisms to monitor public concerns and social media information on food safety and response.
9. Develop media and FBO sensitization programmes on food safety.
10. Encourage incorporation of food safety-related lessons and activities in school. "

The strategic actions proposed by WHO could be a good reference for upgrading the food control system of Nepal. Moreover, government of Nepal has recently approved “national food safety policy 2076”. However, the level of advocacy of the document is almost absent. I had difficulty finding the correct document last week. It was very strange but a bitter truth. We were confused even in the name of the document. It shows the level of importance that we have given to it. It was difficult finding the document even in the website of DFTQC. Thankfully, it was available in the website of SPS enquiry point. It shows the level of importance we have given to the national food safety policy. Does it mean that the document was prepared only as a showpiece and not for implementation? If it was not necessary, why did we use so much resources and effort to formulate it?

There was a time when we used to blame “lack of food safety policy” for all our weakness and incapability. We don’t have that excuse anymore. This document now exists, but probably sleeping inside our showcase or drawer. I would like to request all the food safety professionals to read it once, because it is our bible/geeta (whatever you like to say). We should wake this document up and implement it, if we really want to upgrade the food control system of Nepal.

Hope, our seniors have something to say about it. Waiting for your feedback.

Click here to read National food safety policy 2076.

References:

Framework for Action on Food Safety in the WHO South-East Asia Region. New Delhi: World Health Organization, Regional Office for South-East Asia; 2020. Licence: CC BY-NC-SA 3.0 IGO.

WHO estimates of the global burden of foodborne diseases: foodborne disease burden epidemiology reference group 2007-2015