Sunday, April 22, 2018


Food exports from India top refusal list prepared by US FDA; 44 alerts
Wednesday, 09 January, 2013, 08 : 00 AM [IST]
Akshay Kalbag, Mumbai
In August 2012, the US Food and Drug Administration (FDA) subjected Indian food imports to 205 refusals, thus putting the country on top of the list of refusals. Many of these were on the grounds of misbranding and adulteration.

In comparison, during the same period, 189 Chinese food imports were refused in the United States. In fact, some notable brands were rejected by the American food regulator due to the stringent food laws prevalent in the United States.

In September 2012, there were 173 refusals from India. In fact, on September 27, 2012, sweet and sour gram mix – a product manufactured by Haldiram Manufacturing Co Pvt. Ltd – was refused on the grounds of adulteration under Sections 402(a)(1) and 801(a)(3), and the entry in the chargesheet was, “The article appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.”

A repeat offender
September 7, 2012: Haldiram's Khatta Meetha was refused because it contained Salmonella
September 25, 2012: Haldiram's All In One, an assorted snack pack, was refused for the same reason.

The highest number of refusals of Indian food products was recorded in June 2012, when 371 products were refused, and July 2012, when the US FDA refused 273 imports from the country.
In January 2012, a Nestle India Ltd product was refused on the grounds of misbranding, because the label bore an unsubstantiated health/nutrient content claim.  

Import alerts & refusals
The India office of the US FDA issued a statement clarifying import alerts and import refusals from India. It also explains the American regulatory body's mission and contains the list of products subject to examination by the FDA when they are imported to the United States.

The office of the regulator, based in New Delhi, stated, “FDA's mission is to enforce the Federal Food, Drug and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health and safety, apart from being affordable. These laws apply equally to domestic and imported products.”

“With the exception of most meat and poultry products – which are regulated by the US Department of Agriculture (USDA) – all food, drugs, biologics, cosmetics, medical devices and electronic products that emit radiation, as defined in the FD&C and related Acts, are subjected to examination by FDA when they are imported or offered for import into the United States,” it said.

It mandated that all imported products meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat and produced under sanitary conditions; drugs and devices must be safe and effective, and cosmetics must be safe and made from approved ingredients.

“Radiation-emitting devices must meet established standards, and all products must contain informative and truthful labelling. As defined in the FD&C Act, the term adulteration has to do with a product's content, such as the addition of a substance which makes a product inferior, impure, not genuine, etc. Misbranding includes false or misleading statements on labels,” US FDA stated.

FDA did not divulge any details about FDA's import programme or general procedures, import alerts [of which there are two types - detention without physical examination (DWPE) and DWPE with surveillance], detention without physical examination (DWPE) and computerisation, as these are currently under revision. But it spoke about foreign trade zones, additional forms and devices.

Foreign Trade Zones
A foreign trade zone (FTZ) is a Customs-designated area in the United States to hold or manipulate goods for an unlimited period of time awaiting a favourable market in the United States or nearby countries/areas without being subject to Customs entry, payment of duty, tax or bond.

These areas are considered outside the Customs territory of the United States for Customs importing procedures. However, the location of an establishment in an FTZ has absolutely no bearing on the jurisdiction or the applicability of the laws administered by the Food and Drug Administration.

Foreign trade zones are a part of the United States, and the movement of regulated products into or out of such zones – including export – constitutes inter-state commerce. Therefore, regulated products in foreign trade zones must comply with those laws that come within the purview of the FDA.

Additional forms
In addition to the mandatory entry forms, certain products require specific information to be presented to FDA at the time of import. Foreign companies must register and file processing information before importing any low-acid canned food or acidified low-acid canned food to the United States.

The information must be provided to FDA for each applicable product at the time of import in order to assure compliance with the registration and process filing acceptance, which is taken care of by the LACF registration coordinator (HFS-618), regulatory food processing and technology branch.

The branch is a division of hazard analysis and critical control points (HACCP), Centre for Food Safety and Applied Nutrition, Washington, DC. The forms required to be filled for the same are FDA 2541 (establishment registration); FDA 2541a (food process filing for all methods except low-acid aseptic), and FDA 2541c (food process filing for all methods except low-acid aseptic).

The Federal Import Milk Act requires a permit for milk and cream – including sweetened condensed milk – imported into the United States. Information regarding how to obtain a permit is discussed to the FDA, Regulations and Enforcement Branch, Division of Program and Enforcement Policy (HFS-306), Washington, DC.

Although it is not mandatory for foreign drug companies to register their establishments, they must list their products with the FDA. The forms required to obtain a labeller code (FD 2656) and drug list their product (FD 2657) should be requested from the Centre for Drug Evaluation and Research, Product Information Management Branch (HFD-058), Rockville, Maryland.

Drugs are restricted from import unless they are covered under an investigational new drug exemption (IND) or by an approved new drug application (NDA). Information on regulations covering INDs or NDAs and application forms should be required from CDER Executive Secretariat (HFD-8), Centre for Drug Evaluation and Research, Rockville, Maryland.

Medical devices must meet the regulations laid down by the US regulatory body prior to their import into the United States. FDA does not recognise regulatory approvals from foreign countries or areas. Some devices are of the type that requires a pre-market notification [510(k)] submission.

If a device is of the said type, it becomes mandatory to submit a 510(k) when the following occur – (a) a foreign manufacturer intends to export a medical device that has never been shipped to the US before; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the US, or (c) changes or modifications to a legally marketed device that could significantly affect its safety of effectiveness.

All foreign firms are required to both register their establishments, identify a US agent and individually list their devices before importing them into the United States. Complete information on registration and listing requirements and processes can be obtained either by contacting the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) or visiting the Registration and Listing website.

Form FDA 2877 (Declaration for Radiation Standard) is required for radiation-emitting electronic products entering the United States.

India joins dubious club
Between 2011 and now, India entered the top ten countries as far as import alerts were concerned. US FDA issued 44 import alerts to the country.

Import alerts in December 2012
Detention without physical examination of raw and cooked shrimp from India (Import alert number 16-35, dated December 2, 2012)
Detention without physical examination and surveillance of food products containing sulphites (Import alert number 99-21, dated December 3, 2012)
Detention without physical examination of food products due to the presence of Salmonella (Import alert number 99-19, dated December 5, 2012)
Detention without physical examination of food products due to the presence of Aflatoxin (Import alert number 23-14, dated December 6, 2012)
Detention without physical examination of white or brown Basmati rice from India (Import alert number 02-01, dated December 11, 2012)
Detention without physical examination of seafood products due to the presence of Salmonella (Import alert number 16-81, dated December 12, 2012)

Detention without physical examination of raw agricultural products for pesticides (Import alert number 99-05, dated December 12, 2012)
Detention without physical examination of processed foods for pesticides (Imported alert number 99-08, dated December 12, 2012)
Detention without physical examination and guidance of foods containing illegal and/or undeclared colours (Import alert number 45-02, dated December 13, 2012)

Import Refusal Report
The Food, Drug and Cosmetic Act (henceforth referred to as the Act) authorises FDA to detail a regulated product that appears not compliant with the Act. The FDA district office will then issue a Notice of FDA Action specifying the nature of the violation to the owner or consignee.

The owner/consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If he fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another Notice of FDA Action refusing admission to the product. The product then has to be exported or destroyed within 90 days.

The import refusal reports (IRRs) on those products for which a determination was to refuse administration to part or all of the product offered for import. They are generated from data collected by FDA's operation and administrative system for import support (OASIS) and updated on a monthly basis.

Each month, the IRR is sorted by country/area and by product [based on the industry code, namely the first two characters of FDA's product code (for instance, all fishery/seafood products will be coded 16)]. This information is then made available to the public, along with the information about the products that are found to be in violation of the Act.
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