Bioterrorisms New Rules: Are You Ready?

Bioterrorisms New Rules: Are You Ready?

byLoren Israelsen

By now, everyone engaged in any aspect of the food and dietarysupplement industry should be preparing to comply with the Food and DrugAdministrations (FDA) bioterrorism on regulations, which become effectiveDec. 13, 2003. As a reminder, this legislationofficially known as the PublicHealth Security and Bioterrorism Preparedness and Response Act of 2002(PL107-188)was passed in June 2002 to enhance efforts to protect the U.S.food supply from potential acts of bioterrorism or adulteration. Given the highdegree of urgency placed on food security, Congress mandated FDA have this newlaw in effect by December 2003.

The key elements of PL107-188 are as follows:

Food Facility Registration: Everyfood facility worldwide that is engaged in manufacturing, processing, packagingor holding foods for consumption in the United States must register each of itsfacilities, foreign and domestic. This includes an estimated 100,000 foreignfacilities, as well as all companies making foods, food ingredients, dietarysupplements, colors, flavors and excipients. All herbs, vitamins,minerals, amino acids, probiotics, marine products, etc., that are labeled orsold as dietary ingredients or dietary supplements in the United States aresubject to this requirement.

Products (herbal extracts, for example) regarded as drugs inChina or Europe but sold as foods under the Dietary Supplement Health andEducation Act (DSHEA) in the United States trigger all of the requirements ofthe bioterrorism legislation. Companies should not mistakenly believe thatforeign drug status of an ingredient exempts the company or ingredient from thislegislation. In addition, each foreign company must designate an agent to act onits behalf as part of this registration process. After the effective date inDecember, any food or food ingredient offered for importation into the UnitedStates will be denied entry unless the foreign firm and importer are properlyregistered. I believe, based on a recent round-the-world trip and extensivecorrespondence with colleagues on all continents, a huge number of foreigncompanies are completely unaware of this mandatory requirement and will onlyfind out when their goods are held up at the U.S. border on or after Dec. 13.All food and supplement companies are urged to be in close contact with theirsuppliers to avoid costly disruption and business interruption that would followthe refusal and delay of goods into the United States.

Prior Notice Submission to FDA: Thesecond key element is a new procedure whereby all shipments of foods enteringthe United States after Dec. 13 must be accompanied by a submission to FDA of anotice providing the identity of the food or food ingredient and other specificdetails about the source, origin, the goods and U.S. port of entry. An estimated20,000 shipments per day will be subject to this requirement. All notices must be sent electronically and must be receivedby FDA within a very narrow window of time prior to arrival of the products intothe United States. Any incomplete or incorrect submission will cause delays inthe foods entry into the United States.

FDAs Detention Authority and Inspection of Records: Thethird key element grants FDA expansive new administrative detention authority tostop suspicious goods if FDA reasonably believes the goods areadulterated and present a threat of serious adverse health consequences or deathto humans or animals. While this legislation and implementing regulations defineadulteration as intentional adulteration, many observers believe FDA willlikely interpret this to include any type or form of adulteration from any causeor source, not just intentional acts of adulteration. This could dramaticallyaffect a number of products currently shipped into the United States. Botanicalsfrom China, India, Eastern Europe or other regions of the world, for example,may be exposed to various industrial pollutants, contaminants, herbicides orpesticides that would render such herbs adulterated but heretofore have not beeninspected or closely examined by FDA at the port of entry.

It is becoming clear that a higher standard of quality,cleanliness and purity is urgently needed for all inbound dietary ingredientssold in the U.S. market. Substantial funds have been allocated by Congress toallow FDA to hire new inspectors and to dramatically increase the number of foodinspections both at the ports and at domestic facilities. Dietary supplementcompanies should not be surprised to see an FDA inspector in the coming monthsor to have those inspectors requesting access to records which heretofore havenot been available to them under prior food law. FDA now has expansive authoritybased on a new but very broad definition of adulteration to detain goods at theport of entry or elsewhere to protect public health. Provisions are made forappeals to release goods held under detention. It has already become clear thatgoods entering the United States are being held longer and without any clearreason before being released.

Record Maintenance and Inspection: Thefourth element involves maintenance and inspection of records for foods. FDAwill now have access to a wide range of records where there is a reasonablebelief that a food or dietary supplement is adulterated. This rule applies toall records relating to the manufacturing, processing, packaging, distribution,receipt, holding or importation of such foods or supplements. Farms andrestaurants are excluded, as is information such as recipes, financial data,personnel records, research data and sales data. However, FDA inspectors may nowask for all records relative to the shipment, receipt, holding, storage orresale of any food, food ingredient or supplement.

Given the seriousness with which Congress and FDA takebioterrorism and food security, food and dietary supplement companies are welladvised to take all possible precautionary steps to comply with the registrationand prior notice requirements as soon as possible. FDA is frantically trying todevelop and issue final regulations for this law by mid-October, and it isunclear whether FDA will grant any extensions of time for facility registrationor prior notice submissions beyond the statutory date of Dec. 13, 2003.

In short, within a few months, the food, dietary supplement,dietary ingredient and excipient industries worldwide will be operating under anew and far stricter regulatory environment that will affect thousands ofproducts entering the United States. Many foreign suppliers are, understandably,fearful of the U.S. legal and regulatory process and may be uneasy about filingofficial papers with the U.S. government. Although time is short, U.S. companiesshould contact their foreign suppliers to assure them that all necessaryregistration and prior notification submissions are being attended to. Manycompanies are also taking the precautionary step of building a safety inventoryin the fourth quarter of 2003 to avoid interruption of critical raw materialsand supplies.

The time to prepare for these major changes is now!

Loren Israelsen, president of LDI Group Inc., has 20 years ofexperience in the supplement, phytomedicine and functional food fields. Hisbackground includes serving as president of Natures Way, dietary supplementissue manager to the Trans Atlantic Business Dialogue (TABD), and advisor to theOffice of Dietary Supplements on botanical research priorities. His work asexecutive director of the Utah Natural Products Alliance (UNPA) was instrumentalin the introduction and passage of DSHEA.