Top 5 Highlights of FDA Accomplishments in 2013—Snapshot Year in Review: Why the United States Needs a Food and Drug Administration.

Does the United States Needs a Food and Drug Administration? Year in Review—Top 5 Highlights of FDA Accomplishments in 2013

Does the United States even need a Food and Drug Administration (FDA)? The role and mission of FDA has been debated for years.  The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Food Safety Modernization, Drug Quality and Security, Tobacco Products, Antibiotic-Antimicrobials Use in Food Producing Animals and Dietary Supplement Enforcement.

DRUG SAFETY—DRUG QUALITY and SECURITY ACT

This necessary and milestone legislation (H.R. 3204) enacted towards the end of 2013, addresses federal regulatory authority over pharmacy compounding. Unfortunately, this legislation was enacted in response to the unnecessary deaths associated with large scale compounding. Additionally, this law contains “track and trace” provisions throughout the drug supply chain.

DIETARY SUPPLEMENT OVERSIGHT

Dimethylamylamine DMAA—Muscle Building and Performance Enhancement

Dimethylamylamine commonly known as (DMAA) provides an excellent illustration example of issues related to post-market enforcement. DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement.  DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement.  According to FDA, medical issues associated with DMAA include elevated blood pressure, potential cardiovascular problems such as heart attack, shortness of breath and tightening of the chest.

The following link contains the FDA warning letters. http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ucm346576.htm

The following link contains the response letter from FDA to USPlabs. http://1.usa.gov/1lcJC77

ANTIMICROBIAL RESISTENCE  

At the end of 2013, FDA issued a guidance and proposed rule about a phase out of antimicrobial drugs in food animals for food production purposes. According to FDA, the agency issued voluntary guidance that promotes the judicious use of antibiotics in food animal production is preferable because of resource limitations; that is, according to FDA, the agency would use fewer resources compared to withdrawing the animal drugs on an individual basis

VETERINARY ACTION—ANTIMICROBIAL VOLUNTARY PHASE OUT

Final Guidance and Proposed Rulemaking Rx Status

http://1.usa.gov/1bHsi92

TOBACCO PRODUCTS REGULATION

Tobacco Product Marketing Orders

http://1.usa.gov/1kCu7aV

Tobacco products are regulated so differently than other FDA regulated products due to the fact they are: harmful yet still extensively used consumer products; and responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. A company who desires to market a new tobacco product has the following options available.

There were 17 SE orders, 13, NSE orders and 162 Report Withdrawals from pre-June 2013-December. http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm

MODERNIZING FOOD SAFETY

Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States.  Major accomplishments include a final rule and five proposed rules.

Final Rule Administrative Detention of Food 
 Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace.  A guidance was issued as well titled: Guidance For Industry on Administrative Detention
  was issued on March 7, 2013 FDA released revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

5 Proposed Food Safety Rules: Preventive Controls; Produce Safety; Foreign Supplier Verification, Third Party Accreditation and Intentional Adulteration Mitigation Strategies.

1. Proposed Rule: Preventive Controls for Human Food The proposed rule issued January 2013 would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls.

http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

2. Proposed Rule: Produce Safety The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0001

3. Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals— On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. http://1.usa.gov/1jEeD8l

4. Proposed Rule: Third Party Accreditation of Auditors or “Certification Bodies”— On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

5. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

This proposed rule would require the food businesses in the United States and abroad to take measures to prevent facilities from being the target of intentional attempts to contaminate the food supply. http://1.usa.gov/1fVCv2p

RECOMMENDATIONS 

Despite the federal government shutdown, FDA did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA”. Hopefully though the proposed rules will be finalized shortly and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2014.

 

FDA’s Lucky 13

FDA’s Lucky 13 and Why We Need the United States Federal Food and Drug Administration

Decorative Contact Lenses, Temporary Tattoos, Novelty Makeup, Food Safety and more…

This blog is less formal than usual-yet still provides key information and demonstrates “why” the United States public still needs the United States Federal Food and Drug Administration. Many in the United States celebrate Halloween in high fashion and FDA is right in step. FDA launched an informative website titled:

‘Lucky 13’ Tips for a Safe HalloweenThe information applies to products regulated in the personal care area, medical device arena, foods, novelty-makeup and color additives.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230283.htm

Decorative Contact Lenses— Decorative Contact Lenses: Is Your Vision Worth It? 

A word about decorative contact lenses and a link.  Here is what FDA recommends. http://www.fda.gov/downloads/ForConsumers/ConsuperUpdates/ucm275184.pdf 

Here is just a capsule of FDA recommendations.

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Buy the lenses from a seller that requires you to provide a prescription, whether you go in person or shop online.

Novelty Make-up-Think you have it covered.

Well think again and take a look at what FDA thinks.

 http://1.usa.gov/2XHDVa

Temporary Tattoos 

Temporary tattoos are not necessarily safe and are not necessarily regulated as strongly as one might assume. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm343932.htm

This capsule view succinctly demonstrates “the why” of FDA.

Modernizing the U.S. Food Supply— A Progress Report on FDA Proposals

Food Safety Modernization Progress Report

Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States.  Major accomplishments include a final rule and four proposed rules.Here is a synopsis of the final and proposed rules.

Final Rule Administrative Detention of Food 


Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. The final rule issued February 2013 adopts the interim final rule, “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change.  

Guidance For Industry on Administrative Detention


On March 7, FDA released a revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

Proposed Rules: Prevention, Produce Safety, Foreign Supplier Verification and Accreditation

  • Preventive Controls;
  • Produce Safety;
  • Foreign Supplier Verification, and
  • Third Party Accreditation

Proposed Rule on Preventive Controls for Human Food

Preventive Controls Major Provisions Summary: This proposed rule, issued January 2013, would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:

  • A written food safety plan;
  • Hazard analysis;
  • Preventive controls for hazards that are reasonably likely to occur;
  • Monitoring;
  • Corrective actions;
  • Verification; and
  • Associated records.

Proposed Rule for Produce Safety

Produce Safety Major Provisions Summary: This proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The following are the proposed new standards in the following major areas:

  • Worker Training and Heath and Hygiene;
  • Agricultural Water;
  • Equipment, Tools, and Buildings; and
  • Sprouts

Foreign Supplier Verification Program 

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Summary: On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act (FSMA).

FSVP Requirements: Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:

  • Compliance Status Review
  • Hazard Analysis
  • Verification Activities
  • Corrective Actions
  • Periodic Reassessment of the FSVP
  • Importer Identification and
  • Recordkeeping

Third Party Accreditation of Auditors or “Certification Bodies” 

Accreditation Rule Summary: On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. The proposed rule would implement Section 307 of the FDA Food Safety Modernization Act (FSMA). The proposed rule contains requirements relating to auditing and certification of foreign food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.

Model Accreditation Standards Although not part of the proposed rule, the FDA plans to issue draft model accreditation standards that would specify what qualifications a certification body must have to qualify for accreditation, such as the minimum requirements for education and experience for third-party auditors and their audit agents. FDA will issue the Model Accreditation Standards in draft and open a docket to accept comments. After considering the comments received, the FDA will finalize the standards.

Assessment Issues

The major issue with these proposals involves the timeframe for these proposed rules. Many will opine that FDA is again “dragging its feet”. After all, the Food Safety Modernization Act was signed into law in early January 2011. Now, over two years later FDA finally announced four proposed rules and only one final rule was solidified. Why did it take so long or did it? The answer is far from clear cut. Perhaps the lengthy timeframe as some would argue is because these are complicated issues and FDA needs to ensure that administrative law due process procedures are adhered to with proper notice and comment. The question remains though as to when the four proposed rules will be finalized. If FDA receives comments that would essentially change the proposed rule in a substantial manner, then FDA would have to return to the “drawing board” and announce a new proposed rule(s).  Hopefully, that will not occur as the safety of the United States food supply remains at stake.

 

I’ll Take a Side with My Sirloin Horsemeat

Lately, the controversy about horse meat has resurfaced in the United States.Here is a recent update. On November 1, 2013 the federal District Court ruled against Front Line Equine and reopened the door to horse meat slaughter and packing facilities. The District Court in New Mexico dismissed the case which challenged USDA inspections in horse meat facilities without going through extensive and formal environmental reviews. However, Front Range Equine Rescue filed a motion for a temporary injunction with the Court of Appeals  for the 10th Circuit. The Court of Appeals  granted the motion which stayed  the district court’s November 1  ruling.  The Court of Appeals issued a temporary stay of the  lower court opinion over USDA inspections of horse meat slaughter and packing facilities. Stay tuned for  more to come as this case continues to unfold.

The horse meat scandal in Europe http://www.guardian.co.uk/uk/horsemeat-scandal has awakened the United States debate. What is the argument? Is eating horse meat any different than eating beef, lamb, veal, chicken or turkey? Apparently, in the United States it is whereas in some countries it is a delicacy. This is far from just a legal issue. Rather, it has become an emotional issue for many animal rights advocates and organizations and it does raise the issue of societal values and mores. According to a recently released Congressional Report on this topic, back in 2006, two Texas plants and one in Illinois slaughtered approximately 105,000 horses for human food for export, primarily for European and Asian consumers. Subsequently, due to legal action, the Texas plants were shuttered. The Illinois plant closed due to a state ban. See: Congressional Research Service April 9, 2013 Horse Slaughter Prevention Bills and Issues, 7-5700, RS21842.

Background: United States Department of Agriculture USDA Inspection of Meat 

The United States Department of Agriculture (USDA) is responsible for the inspection and regulation of meat, poultry, dairy products and eggs (shell eggs include joint responsibility with FDA). The specific law that provides USDA with authority to regulate meat products is the Federal Meat Inspection Act.  USDA is involved in the inspection and regulation of meat and poultry products at all production stages. In addition to inspection, USDA approves new plant construction and equipment, develops and supervises plant sanitation standards and trains inspection personnel. USDA is organized by service organizations such as the Food Safety and Inspection Service. The Food Safety Inspection Service personnel conduct inspection under the Federal Meat Inspection Act (21 U.S.C. 603 Examination of animals prior to slaughter; use of humane methods). http://uscode.house.gov/download/pls/21C12.txt

There were bills in the 111th Congress would have made it a crime to knowingly possess, ship, transport, sell, deliver, or receive any horse, carcass, or horse flesh intended for human consumption. Although the proposals were referred to the House Subcommittee on Crime, Terrorism, and Homeland Security and the Senate Committee on the Judiciary, there was no further action.

A general provision in the House-passed FY2012 Agriculture appropriations bill (H.R. 2112,§739) would have continued to prohibit any funds to pay salaries or expenses of the Food Safety Inspection Service personnel to inspect horses under the Federal Meat Inspection Act (21 U.S.C.603). However, this general provision was not included in the Senate-passed version of H.R. 2112, nor was it included in the final bill (P.L. 112-55). That means FSIS could again inspect horse meat at the horse processing plants. A facility in New Mexico became the first to apply for a grant of inspection from FSIS following the lifting of the ban. Another facility in Missouri also has an application pending. Valley Meat Company, LLC, the New Mexico facility, filed a lawsuit against USDA for its failure to provide inspections for horse slaughter. The lawsuit may eventually become moot as the facility in New Mexico could be approved in the near future.

http://equinewelfarealliance.org/uploads/Complaint_against_USDA.pdf

A Few Considerations

No doubt this issue will not go quietly away nor should it. The goals of the Federal Meat Inspection Act center on the public health and safety. Which is better—humane slaughter of horses in the United States or horse abandonment which leads to starvation and eventual death? Perhaps this issue is emotionally based. Why is eating horse meat any different than eating beef? Safety is paramount and how will the public be assured that the horse meat is fit for human consumption is still uncertain.

Stay Tuned

The FY2012 appropriation bill and the Continuing Resolution (HR 933) on which it is based again permits FSIS to inspect horse processing plants. Previous bills included language that stated none of the funding for FSIS could be used to inspect horse slaughter facilities. The debate will not end. The controversy rages on as some states have even enacted legislation that bans horse slaughter with Illinois as an example while other states endorse horse slaughter.

Recent federal proposals have been introduced such as the Safeguard American Food Exports Act  (SAFE Act) of 2013 on March 12. SAFE would prohibit the sale, transport, import or export of equines, or their parts, to be slaughtered for human consumption. http://atwork.avma.org/2013/04/15/horse-slaughter-bill-is-revamped-reintroduced/