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Laws and Regulations Committee Update 2/19/2019

February 22, 2019 1:15 PM | Amy Bonsell (Administrator)

February 19, 2019

Federal Register

Food and Drug Administration


Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Sanitary Transportation of Human and Animal Food

Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02751 PDF 8 Pages (38.5 KB) Permalink

  • Ø  21 CFR 1.900


Agricultural Marketing Service


Processed Raspberry Promotion, Research, and Information Order; Termination of Assessments

Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02775 PDF 12 Pages (141 KB) Permalink



Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02700 PDF 7 Pages (132 KB) Permalink

  • Ø  Export Fruit Regulations – Export Apple Act (7 CFR 33) and Export Grape and Plum Act (7 CFR 35)


International Trade Administration


Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Pasta from Italy

Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02786 PDF 4 Pages (85.6 KB) Permalink


Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty

Filed on: 02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02785 PDF 4 Pages (161 KB) Permalink


U.S. Codex Office



Codex Committee on Contaminants in Foods

Filed on:  02/19/2019 at 8:45 am Scheduled Pub. Date: 02/20/2019

FR Document: 2019-02743 PDF 6 Pages (258 KB) Permalink






Product Description




Chukar Cherries

Ultra Dark Chocolate Cherries

Undeclared milk

Chukar Cherries



Choco Chimps, Gorilla Munch and Jungle Munch cereals

May contain undeclared gluten (wheat and barley)

Nature’s Path Foods



Baby Gripe Water herbal supplement

Undissolved ingredient, citrus flavonoid

Kingston Pharma, LLC


Smoked Alaska

Smoked Silver Salmon

Potential for Clostridium botulinum

Smoked Alaska Seafoods, Inc


Jansal Valley

Dukkah 2.5oz

May contain glass pieces

Sid Wainer and Son



United States Issues WTO Counter Notification Concerning India’s Market Price Support for Various Pulses



Feb 15, 2019 | PDF

  • FSIS Posts Updated Quarterly Sampling Results
  • FSIS Posts Updated Dataset on Imports
  • FSIS Posts Next Set of Establishment Specific Datasets
  • FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella


Product Recalled

Date of Recall

Retail Distribution List

015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation | En Español

Feb 11, 2019

Feb 14, 2019

015-2019 Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation | En Español

Feb 11, 2019

Feb 14, 2019



AMS Issues Complaint against R & W Farms LLC, Wanda Thompson and Rickey G. Thompson for Alleged Violations of the P&S Act

AMS Reaches a Consent Decision and Civil Penalty with Gary Wedel



USDA Provides $66 Million in Fiscal Year 2019 to Protect Agriculture and Natural Resources from Plant Pests and Diseases



  • Ø  Dietary supplements such as vitamins, minerals or herbs are regularly used by 3 out of 4 consumers and can be beneficial. In today’s #FDA #SundayTweetorial I review FDA’s efforts to ensure safety of these products through steps to modernize our oversight .
  • Ø  Some background: Under the Dietary Supplement Health and Education Act (DSHEA) supplements are a type of food. Companies are subject to a number of requirements around manufacturing and product labeling but #FDA review isn't needed to market their product .
  • Ø  Since DSHEA was enacted in 1994 the supplement industry has evolved in more ways than envisioned; expanding from $4 billion in sales and 4,000 products to $40 billion in sales and about 80,000 products. This growth offers new opportunities but also creates the potential for risks
  • Ø  As supplements have grown in popularity so too have the number of products on the market that are potentially dangerous or make unproven or misleading health benefit claims. For these reasons #FDA is implementing new steps to modernize our oversight, and considering other actions
  • Ø  Although the vast majority of manufacturers in the supplement market act responsibly; a small number of bad actors are exploiting the halo created by the quality work of legitimate companies and promulgating products with inappropriate claims or potentially harmful ingredients.
  • Ø  I’m concerned that changes in the supplement market are outpacing the evolution of our own policies to ensure safety and our capacity to manage emerging risks. So, I’ve concluded that we will take new steps to modernize and strengthen our overall approach to these products.
  • Ø  At my direction, the #FDA established an internal Dietary Supplement Working group tasked with taking a close look at our organizational structures, processes, procedures and practices to identify new ways to modernize and strengthen our regulatory oversight to ensure safety.
  • Ø  Last week I unveiled our initial efforts to help advance the group’s three policy priorities for dietary supplements as part of our new work stream: Protecting consumers from unsafe products; ensuring product integrity and quality; and promoting informed consumer decision making.
  • Ø  One important new step is developing a rapid-response communications tool that will more quickly alert consumers to avoid buying or using products with unlawful or potentially dangerous ingredients and notify industry that they should avoid making or selling these products.
  • Ø  Another is providing guidance on submitting required safety notifications for new dietary ingredients (NDIs), ingredients introduced after DSHEA. These submissions are #FDA’s only opportunity to review the safety of an NDI before they reach consumers .
  • Ø  Knowing we don’t have all the answers, we’ll also be holding an open meeting this spring to hear from the public about other steps we might consider for advancing responsible innovation - such as clarifying the scope of permitted ingredients or opening a dialogue on exclusivity.
  • Ø  As we move forward, we’ll also reinforce important existing activities. This includes collaborative research with industry, academia, and government partners, such as our new Botanical Safety Consortium, which we formed to look at novel ways for using toxicology tools….
  • Ø  …and our continued efforts to protect public health through enforcement action. Last week we posted letters to 17 companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Other actions are in the works
  • Ø  These health fraud products haven't been proven to be safe and effective for diseases and health conditions they claim to treat. They prey on vulnerable populations, cause consumers to waste money on unproven products, and often delay proper medical care
  • Ø  Some believe that modifying DSHEA to add a product listing requirement could improve transparency, promote risk-based regulation and establish a mechanism to easily ID bad actors without overly burdening responsible firms. We look forward to future dialogue on this matter.
  • Ø  Dietary supplements can play an important role in our lives as we strive to stay healthy. With modernization of our oversight, our goal is to preserve consumers’ access to lawful supplements while upholding our obligation to protect the public from unsafe and unlawful products.



  • Ø  Standards (such as GS1) + New Enabling Technologies (such as blockchain) = a New Era of Scalable & Interoperable Food Traceability solutions. It CAN be done. @GS1_US #blockchain #traceability
  • Ø  THREAD: This week, FDA released findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce. …
  • Ø  While the report doesn’t explain the totality of what happened, it’s more than what we had before and it provides insights to inform future preventive efforts.
  • Ø  1) Survivability - finding the outbreak strain in sediment of the water reservoir is significant, as studies have shown E. coli can survive in sediments longer than in water. It’s possible outbreak strain may have been present in on-farm water reservoir for months or even years.
  • Ø  2) Verification - while the one farm had a procedure in place to treat the agricultural water with a sanitizer before use, the investigation team noted verification records did not document sufficient sanitizer to adequately reduce any pathogens present.
  • Ø  3) Traceability - without the ability of industry to rapidly trace origin of products to growing region or source, public health advisories issued during outbreaks will continue to be - out of necessity - broad & likely to include farms & regions that may not be responsible.
  • Ø  Fresh leafy greens are an important part of an overall healthy diet. Let’s work “together” and with a “shared sense of urgency” to make sure they’re safe.



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