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Practice of Medicine or Drug Biologic Product—Regenerative Sciences, LLC

“Practice of Medicine” or FDA Authority to Regulate

The Food and Drug Administration and the Authority to Regulate

USA v Regenerative Sciences

Regenerative Sciences, LLC vigorously defended its position that FDA could not regulate the practice of medicine in its Regenexx™ treatment or Regenexx-C™ cultured treatment which uses Mesenchymal adult stem cells (MSCs) that originate primarily from bone marrow. The company promotes the Regenexx™ treatment as a “non-surgical” treatment option for joint or bone pain in the hip, knee, shoulder, back or ankle as well as non-union fractures. The dispute with FDA has been ongoing since at least 2008 when FDA sent correspondence to Regenerative Sciences depicting the cell treatment as a drug or biologic. FDA conducted an inspection and found violations of current Good Manufacturing Practices (cGMPs). The United States Court of Appeals for the District of Columbia Circuit upheld the District Court and the United States Food and Drug Administration’s (FDA’s) argument that Regenerative Sciences “Cultured Regenexx Procedure” was a biological drug subject to FDA approval through the biologics licensing application (BLA) process. The court of appeals upheld the permanent injunction against the use of the biological drug without FDA approval. The issue focused on the practice of medicine versus the regulation by the United States Food and Drug Administration. This distinction has far reaching ramifications. 

Issue the Court of Appeals Addressed

In the civil enforcement action, the court of appeals had to decide “whether the appellants—three individuals and a related corporate entity—violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline.” The court of appeals determined that FDA had the authority to regulate the product and affirmed the district court’s judgment and the permanent injunction it entered against appellants.

What Regenerative Sciences, LLC Argued

Regenerative Sciences, LLC (Regenerative Sciences) alleged several arguments that their product did not fall within FDA regulatory authority; however, the court rejected all of the arguments. For example, Regenerative argued that the Federal Food, Drug, and Cosmetic Act (FDCA) did not apply because the product was a procedure overseen by state “practice of medicine”. Another argument advanced by Regenerative Sciences was that the product was exempt from FDA approval because it was a compounded product and further it was a minimally manipulated product. As mentioned, the court of appeals rejected all of the arguments advanced by Regenerative Sciences.

Looking Ahead

This was a long awaited decision. The future is uncertain in terms of how a court will rule about novel therapies such as the issue in this case. However, no doubt as more technological advances occur, FDA will again be challenged as to the agency’s authority to regulate such products and or procedures.The link to the full case is as follows:

USA v Regenerative Sciences

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.

 

The Horse Meat Slaughter Facility Controversy Continues

Horse Meat Slaughter Facilities Inspection Update

Front Range Equine Rescue et al v. Vilsack et al, Docket No. 1:13-cv-00639 (D.N.M. 11/01/13) 

The controversy about horse meat slaughter facilities has resurfaced again 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 in the United States. According to U.S. District Court Judge Christina Armijo, the United States Department of Agriculture (USDA) is not required to conduct an Environmental impact Statement or an Environmental Assessment. The District Court in New Mexico dismissed the case. Front Range Equine Rescue had  challenged USDA inspections in horse meat facilities.

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.

What is Next…

Stay tuned for  more to come as this case continues to unfold. In the meantime, check out the earlier blog on this topic in April 2013.

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.

Right to Know and Arsenic in Food: Apple Juice and Rice

What is FDA doing about Arsenic in the United States Food Supply?

Besides air, water and soil did you know that arsenic is found in some food? Arsenic can be either inorganic or organic and the type of arsenic matters. Inorganic forms of arsenic are the harmful types and organic forms of arsenic are basically harmless. Both forms of arsenic have been found in soil. Until 1970 arsenic-based pesticides were regularly used in United States agricultural production. Consequently, trace levels of organic and inorganic forms of arsenic can be detected in some agri-business settings. Consequently, there could be arsenic in certain food and beverage products such as apple juice and rice. Does FDA monitor level of arsenic in food? Although FDA has been monitoring the levels of arsenic in foods for several years testing has increased.

Why Test? The short answer is that it is a step in the right direction to test and understand possible arsenic-related risks associated with the consumption of certain foods and remediate if necessary.

“A” is for Apple Juice and Also for Arsenic in Apple Juice

Several years ago, consumer advocates rallied for regulation of arsenic in apple juice. After years of debate, dialog and testing FDA did issue a guidance albeit in draft format in 2013 about acceptable levels in apple juice. Here is the latest.

Is Organic Apple Juice Better? 

According to FDA, the agency does not have clear data that demonstrates organic juice is better than non-organic apple juice in terms of arsenic levels. This is due to the soil where apple juice is grown.

FDA Extends Comment Period for Proposed “action level” for Arsenic in Apple Juice

FDA published a draft guidance in the Federal Register July 15, 2013 (78 FR 42086). The guidance identifies an action level for inorganic arsenic in apple juice that FDA deems both safe and viable under good manufacturing practices. It also describes the FDA’s intended sampling and enforcement approach. The draft guidance proposes an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency for arsenic in drinking water. The U.S. Food and Drug Administration (FDA) has extended by 60 days the period for submission of comments, scientific data and other information in connection with its draft guidance for industry titled “Arsenic in Apple Juice: Action Level.” The new deadline is November 12, 2013.

Rice and Rice Products

FDA released on September 6, 2013 the analytical results of nearly 1,100 new samples of rice and rice products. Approximately one year ago, FDA initially tested 200 samples of rice and rice products. In addition to the analytical results above, the following provide useful information about Arsenic in Rice and Rice Products.

Immediate Short Term Findings

While levels varied significantly depending on the product tested, agency scientists determined that the amount of detectable arsenic is too low in the rice and rice product samples to cause any immediate or short-term adverse health effects.

Long Term Plan-What are FDA’s future plans concerning rice and rice products that contain arsenic? According to FDA, the next steps are to assess the potential health risk from long-term exposure to the arsenic in rice and foods made with this grain.

FDA needs to understand first and then issue regulations to address possible arsenic-related risks associated with the consumption of these foods. FDA is on the right path with apple juice products. Yet, the question remains how long will these next steps take for other foods that might contain arsenic?

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.

 

Summer is Here and so is the Sunscreen Rule

sunThe Sunscreen Rule Update

Now that summer is upon us, here is a summary of the sunscreen rule. Have you seen claims on sunscreen labeling such as “waterproof” or “sweatproof”, or identify their products as “sunblocks”? Well, those terms cannot be used anymore. However, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013. Here are key aspects of this rule.

Standard Test

Establishes a standard test for over-the-counter sunscreen products that will determine which products are allowed to be labeled as “Broad Spectrum. Products that pass this test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).

Front Labeling: Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage are labeled “Broad Spectrum” and “SPF 15” (or higher) on the front. Back Labeling: Informs consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection. By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

Warning Statement: Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 must be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Claims

Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times are permitted on labels: 40 minutes or 80 minutes. Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.”   In addition, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get FDA approval.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm258416.htm

Delay Does not Protect the Ultimate User

Although the Sunscreen Rule was issued June 9, 2011with a compliance date of June 18, 2012, it was delayed until December 17, 2012. Further, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013.

What else is on the “Sunscreen Horizon”?

Sun Sprays 

An Advanced Notice of Rule Making was issued at the same time as the “Sunscreen Rule”. The Notice concerns a data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays).

50+ Is there any Benefit to the 50+ Sunscreens?

FDA proposed a regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”. The FDA proposed Rule sets forth that the maximum labeled SPF value for over the counter (OTC) sunscreen products would be “50&plus”. The proposed rule comes after a data review showed that there is not currently sufficient data to indicate that there is additional clinical benefit above SPF 50. There was not adequate data that demonstrated that a sunscreen product with an SPF value over 50 provided an increase in clinical benefit over a sunscreen product with an SPF value of over 50.

Conclusion

As with other FDA regulation, time will tell if 50+ will be permitted as well as the effectiveness of sprays. Based on prior regulatory efforts that time could continue for years without a settled regulation.

Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use 21 CFR Parts 201 and 310

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/

The Little Red Wine Pill Panacea

Red Wine or a Red Pill

Several years ago- the old adage “an apple a day keeps the doctor away” was tweaked for adults to “a glass of red wine a day keeps the heart healthy”.  The push to drink red wine for purported medical benefits such as heart health became all the rage. http://www.foxnews.com/health/2012/05/21/red-wine-healthy-elixir-or-lot-hype/

Until recently, there was not as much a push to do this. However, the spotlight on the purported medicinal benefits of red wine has become in the forefront again. It appears that there may be other benefits related to aging. See: New Study Validates Longevity Pathway. http://hms.harvard.edu/news/new-study-validates-longevity-pathway-3-7-13 The article discusses a recent revelation that Dr. David Sinclair and his team of researchers found concerning resveratrol and SIRT1. Resveratrol is a compound found in the skin of grapes and berries and also peanuts and it is supposed to increase the activity of sirtuin, SIRT1.  Simply stated, the increased SIRT1 activity shields the body from diseases due to accelerating the mitochondria which normally slows as one ages. According to Dr. Sinclair, Harvard Medical School professor of genetics and senior author, “In the history of pharmaceuticals, there has never been a drug that binds to a protein to make it run faster in the way that resveratrol activates SIRT1”.

How would the Red Pill be Regulated?

It this too good to be true and if it is true how should the “red pill” be regulated?  How would the product be classified—dietary supplement, over the counter pharmaceutical or prescription drug? Wouldn’t drinking a glass of wine suffice? According to a recent report, one would have to drink 100 glasses of wine for any medical benefits to occur.

Classification of the product is important in terms of how the United States Food and Drug Administration would regulate this product. If regulated as a dietary supplement pre-approval is not a requisite. If regulated as a prescription drug, then a New Application would have to be filed with the United States Food and Drug Administration (FDA). The Drug Approval process is time consuming and arduous. Yet, shouldn’t it be arduous when human safety issues are involved?

Who Would Have the Authority to Regulate An “Enriched Wine”?

Suppose wine could be “enriched” to provide medical benefits. Jurisdiction become tricky too. Jurisdiction under this scenario is a legal term of art that refers to the proper government entity that has the authority to regulate.  How is wine regulated and who has the authority to regulate red wine? Is it the United States Department of Treasury, Alcohol, Tobacco, Tax and Trade Bureau (BATT)? Actually, BATT oversees alcoholic beverage regulation except wine beverages containing less than 7 percent alcohol, which are under the jurisdiction of FDA. BATT enforces laws that govern the production and distribution of alcoholic beverages and investigates adulterated alcoholic products with FDA assistance.

Recommendations

To date, the research seems promising and there may be medical benefits yet it appears that more research is needed. The current information and research is not yet definitive as to whether the product would even “work” or be beneficial. The reality is that more research is needed. As much as one can extol the myriad benefits of taking the “little red pill” or drinking red wine (100 glasses?) prudence is recommended. In the meantime, enjoy your red wine for what it is.

Curious About Veterinary Pharmacy Compounding—Who Really has Regulatory Oversight

Veterinary Pharmacy Compounding and Regulatory Oversight

The news about pharmacy compounding has mainly focused on humans. Just recently, the 60 Minutes television program interviewed FDA Commissioner Margaret Hamburg about pharmacy compounding.  Pharmacy compounding usually involves a small quantity of custom made prescriptions. However, this has changed over the years to what some term large scale production. Unfortunately, this matter come to the forefront as a result of the deaths associated with compounded products produced by the New England Pharmacy Compounding Center. I agree with Dr. Hamburg that clear guidance is necessary as well as federal regulatory oversight.  To that end, Congressional action remains paramount. Federal regulatory oversight with clear guidance for the industry is necessary for human as well as veterinary use. The same rules that apply to compounded products for humans should apply to animals, both food producing and nonfood producing and those rules should be federal oversight. This will provide uniformity and provide the industry with a uniform standard.

Veterinary Use of Pharmacy Compounding Products  

However, what about animals and the use of compounded pharmacy products? Do the same rules apply? If so, which rules—federal or state? As indicated on the recent 60 Minutes television program, pharmacy compounding has ballooned from a  “Mom and Pop” process into a billion dollar industry.  Does the regulation of pharmacy compounding even apply to food producing animals? States are the prime regulator of pharmacy compounding yet should there be federal regulatory oversight? 

Congress Needs to Step to the Plate

The landscape has changed in the pharmacy compounding arena from that of compounding for an individual patient to that of large scale production. This is analogous to the changed landscape of health care and the practice of medicine.  The images of “Norman Rockwell’s Going to the Doctor” are no longer. These issues remain in flux with regulation primarily under state jurisdiction until Congress enacts legislation to provide clear guidance to both the United States Food and Drug Administration and industry.

Pharmacy Compounded Products in the Veterinary Arena—Interesting Case Yet No Guidance

Taking this issue one step further—should federal regulatory oversight of pharmacy compounded products for non-food producing animals apply?  The answer is unclear at this point. Interesting, this issue was addressed back in 2011 in the case of United States v. Franck’s Lab. Inc. No. 5:10–cv–147–Oc–32TBS (Sept. 12, 2011), a case which concerned pharmacy compounding for non-food producing animals.  Several polo horses died as a result of use of compounded products. FDA instituted a legal action for an injunction against Franck’s Lab. Inc. and deemed the activity manufacturing and hence being subject to FDA oversight.  In Franck’s Lab., the district court wrote an extensive opinion about the application of federal oversight to pharmacy compounding pertaining to non-food producing animals. The district court judge denied the injunctive relief sought by FDA and ruled that FDA had no authority to regulate in this arena mainly because this type of regulation was historically regulated under state not federal authority. Predictably, the FDA appealed. Subsequently, Wells Pharmacy Network, LLC acquired Franck’s and Franck’s no longer engages in such compounding. A Joint Motion by the government and by Wells Pharmacy Network, LLC to Vacate the District Court’s Judgment and Dismiss the Complaint by the federal government and Appeal by the government as Moot was granted on October 18, 2012.  However, fast forward to 2013 and the answers as to food- producing and  non-food producing animals are still murky.