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.

Summer is Here and so is the Sunscreen Rule

The 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

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.