FDA & USDA Related Articles

USDA Publishes Irradiation Specs for Frozen Ground Beef

The USDA has published 19 pages of technical specifications for frozen, irradiated ground beef. Here are the some highlights:

  • Radiation sources can include gamma ray, electron beam or x-ray.
  • Beef designated for radiation can not be frozen before grinding and must be ground within five days of slaughter.
  • Irradiated ground beef must be tested for Salmonella and E. coli after irradiation.
  • Irradiated fine ground beef must be vacuum packed in thermo formed, tamper proof plastic containers weighing ten pounds.
  • Irradiated ground beef patties can be packed in either ten or twenty pound packages.
  • Shipping containers must bear marks identifying the beef as irradiated and shall state a “best if used by” date of 180 days from the date of production.
  • Products must be maintained in a frozen state from the time of leaving the shipping freezer and throughout the irradiation process.

 

FDA Adopts New Procedures for Submittal of "Qualified" Health Claims

Agency Approves Qualified Claims for Nuts

As reported in the Winter 2003 issue of Food & Marketing Law Update, the FDA has been in the process of developing procedures to “approve” qualified health claims for use on both foods and dietary supplements. Although the FDA won’t admit it, these changes are apparently in response to the court orders in the Pearson v. Shalala case which was a successful First Amendment challenge to the FDA’s limitation on bona fida, on-label health claims.

The regime divides label health claims into four categories:

Rank

Scientific Support for Claim

Qualifying Language (Suggestive)

A
Significant scientific agreement. None
B
Evidence is not conclusive. "although there is scientific evidence supporting the claim, the evidence is not conclusive."
C
Evidence is limited and not conclusive. "Some scientific evidence suggest...however, FDA has not determined that this evidence is limited and not conclusive."
D
Little scientific evidence supporting claim. "Very limited and preliminary scientific research suggests...FDA concludes that there is little scientific evidence supporting this claim."

Rank A claims are the legislatively authorized claims under the NLEA which are subject to a rule making process and once approved are published in the Code of Federal Regulations (“CFR”). For more information about currently approved Rank A health claims see Title 21, subpart E of the CFR. The other claims are not legislatively authorized and therefore will be approved through a non-rule making process.

Beginning September 1, 2003 the FDA will begin accepting petitions for qualified health claims. The petitions will be prioritized on such factors as whether the food or dietary supplement is likely to have a significant impact on serious illness and the strength of the evidence supporting the claim. After a 45-day internal review period the FDA will then post the petition for a 60-day public comment period. After the close of the comment period, the FDA can conduct its own review. Within the next 165 days (i.e. within 270 after filing the petition), the FDA will notify the petitioner of its determination.

The FDA will use a six step interim process in evaluating the scientific support for the health claim. These evaluation steps include (a) the relationship between a nutrient and disease, (b) the identification of individual studies concerning this relationship (c) classification of the studies based upon study design type, (d) designation of study quality (e) ranking of the scientific evidence (i.e., A. B, C or D) and (f) reporting the rank. While using this interim procedure, the FDA intends to continue reviewing the inclusion of qualified health claims in its normal rule making process.

 

FDA Approves Qualified Claims for Nuts and Coronary Heart Disease

The FDA identified four “fast track” health claims for approval. These claims are for (i) omega-3 fatty acids reducing the risk of heart disease, (ii) consumption of fruits and vegetables reducing cancer and chronic illness risk, (iii) reducing the risk of heart disease by using vegetable oils containing unsaturated fats in place of solid fats and (iv) reducing the risk of heart disease by using nuts as a replacement for proteins containing saturated fat.

On July 14, 2003 the FDA approved a qualified coronary heart disease (“CHD”) prevention claim for walnuts and other nuts based upon a petition by the California Walnut Commission. However, the approved qualified claim is different from the claim requested by the Commission. The Commission had petitioned FDA to use the claim “Diets including walnuts can reduce the risk of heart disease.” The FDA rejected this proposal because the FDA concluded that there is not significant scientific agreement regarding walnut consumption and a reduced risk of CHD. Instead, the FDA has approved the following qualified claim: “Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. See nutrition information for fat content.” At the same time, FDA also approved a wider claim that consumption of peanuts and several kinds of tree nuts will reduce the CHD risk. Note the FDA has prescribed specific language on how each claim is to be stated and has imposed additional disclosure requirements and limitations on the claims’ use.

 

Oatrim Added to List of Nutrients That Can Make Health Claim for Fiber and Coronary Heart Disease

In response to a long standing petition from the Quaker Oats Company, the FDA has approved a modification of the existing conventional (non-qualified) health claim linking the consumption of soluble fiber to a reduced risk of coronary heart disease. Effective immediately foods containing oatrim (more technically known as alpha-amylase hydrolyzed oat bran) may make this claim if they meet all of the other requirements in the regulation.

 

FDA Begins Implementation of Bioterrorism Act

Virtually Everyone in the Food Business Will Be Affected

On January 29, 2003 the FDA published Federal Register notices for two sets of proposed rules to implement two of the four required FDA mandates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act.”). The requirements of these four mandates will fundamentally affect the business practices of many domestic and foreign firms that sell food (including dietary supplements) in the United States.

The two published notices are for rules that (a) require, with certain exceptions, the registration with the FDA of every domestic and foreign facility that processes, packs or stores food that is sold in the US and (b) require prior notice to the FDA of every shipment of food imported into the US. The FDA intends to have these rules finalized and its internet based 24/7 registration and import notice systems operational by October 12, 2003. Any person or firm who fails to register a covered facility by December 12, 2003 or who imports of food into the United States after December 12, 2003 without providing prior notice to FDA will be in violation of the act and subject to civil and criminal sanctions.

The FDA has delayed until at least April the publication of the proposed rules to implement the two other mandates in the Bioterrorism Act. One mandate requires that all businesses that manufacture, process, pack, transport, store, or import food into the United States keep a paper trail of all suppliers of the food and the persons to whom the food is sold. We anticipate that these rules will require food manufacturers and processors to keep batch-by-batch records of the sources of ingredients used to make their products. This rule must also be effective no later than December 12, 2003.

The fourth mandate gives the FDA new authority to administratively detain (i.e. without court order) any food that the agency has evidence or information that the food presents a threat of a serious adverse health consequence to either humans or animals. The legislation mandating this rule does not require any association with terrorist threats or activity. There is no deadline for implementation of this rule.

The two proposed rules that have been published by the FDA are far too complex to fully detail in this article. However, some significant items to note are:

Proposed Facility Registration Rule
  • Facilities include businesses involved in the production and distribution of food packaging materials.
  • Facilities mean specific physical locations such as individual plants, warehouses, or retail stores which also engage in wholesale activities (e.g. Costco).
  • Any updates must be reported to the FDA within 30 days.
  • All foreign facilities must have a US based agent. (Currently this requirement only applies to foreign drug manufacturers.)
  • Exempt from registration are farms (including fish farms) which only engage in the sale of raw agricultural products, restaurants, grocery stores, non-profit food establishments (e.g. soup kitchens and food banks), fishing boats that do not engage in on-board processing, facilities subject to USDA regulation and foreign facilities that send food to other foreign facilities for further processing or packing prior to export to the US. Note that mixed facilities which have both exempt and non-exempt operations must be registered.
  • Imported food will not be allowed into the US if it produced at an unregistered, non-exempt foreign facility.

Proposed Import Notification Rule

  • Importers will be responsible for compliance with this rule.
  • This will be a stand-alone system. (The FDA has stated that it will continue to work with US Customs to create a unified system.)
  • Shipments of food which have not been registered will be either refused entry or stored at a secure facility at the importer’s expense.
  • The definitions of country of origin and port of entry are different from the Customs definitions.
  • The notices may be filed no earlier than 3 days before the anticipated entry date of the shipment into the US and no later than noon of the day before entry.
  • Separate notice will be required for each “article,” which appears to be equivalent to an SKU.
  • The notices will require up to 13 elements of information including Customs numbers, identification of foreign manufacturer, type of food based on FDA 7 digit product codes, lot code country of origin, identification of importer and carrier.
  • Certain amendments of the notices as to quantity, port of entry, time of entry will be permitted up to two hours before arrival. No amendments will be allowed as to the type of goods.

Obviously, these newly proposed rules and the new rules expected to arrive in April represent a sea change in regulation for many food businesses. The significance of these changes is compounded by the very short fuse to implement them. Zackler & Associates strongly recommends that you now begin examining your business operations to determine how you might be affected by these new rules. We are available to assist you in that examination and in the establishment to new systems to assure seamless compliance when the rules become effective.