Former U.S. Consulate Guard Sentenced to Nine Years in Prison for Attempting to Communicate National Defense Information to China
Bryan Underwood, a former civilian guard at a U.S. Consulate compound under construction in China, was sentenced today to nine years in prison in connection with his efforts to sell for personal financial gain classified photographs, information and access related to the U.S. Consulate to China’s Ministry of State Security (MSS), announced Lisa Monaco, Assistant Attorney General for the Justice Department’s National Security Division; Ronald C. Machen Jr., U.S. Attorney for the District of Columbia; Valerie Parlave, Assistant Director in Charge of the FBI’s Washington Field Office; and Gregory B. Starr, Director of the U.S. State Department’s Diplomatic Security Service.

Underwood pleaded guilty Aug. 30, 2012, in the U.S. District Court for the District of Columbia to one count of attempting to communicate national defense information to a foreign government with intent or reason to believe that the documents, photographs or information in question were to be used to the injury of the United States or to the advantage of a foreign nation. He was sentenced by the Honorable Ellen S. Huvelle. Upon completion of his prison term, Underwood will be placed on two years of supervised release.

Underwood, 32, a former resident of Indiana, was first charged in an indictment on Aug. 31, 2011, with two counts of making false statements and was arrested on Sept. 1, 2011. On Sept. 21, 2011, he failed to appear at a scheduled status hearing in federal court in the District of Columbia. The FBI later located Underwood in a hotel in Los Angeles and arrested him there on Sept. 24, 2011. On Sept. 28, 2011, Underwood was charged in a superseding indictment with one count of attempting to communicate national defense information to a foreign government, two counts of making false statements and one count of failing to appear in court pursuant to his conditions of release.

“Bryan Underwood betrayed America’s trust by attempting to sell access to secure areas of the very U.S. Consulate compound he was charged to protect,” said Assistant Attorney General Monaco. “Today, he is being held accountable for his actions. As this case demonstrates, we remain vigilant in protecting America’s secrets and in bringing to justice those who seek to compromise them.”

“Access to classified information is a special responsibility to be honored, not a financial opportunity to be exploited,” said U.S. Attorney Machen. “Bryan Underwood is going to prison because he tried to make millions by selling secret photos of a U.S. Consulate to a foreign government. His sentence demonstrates our dedication to jealously guarding our nation’s secrets. We all owe a great debt of gratitude to the agents who detected and stopped Underwood before he succeeded in betraying our country.”

“Bryan Underwood attempted to betray his country by using his access to sensitive information for his own benefit. Fortunately, he was stopped before classified information fell into the wrong hands,” said FBI Assistant Director in Charge Parlave. “Together with our partner agencies, the FBI will continue to diligently work to combat potential acts of espionage that threaten our national security.”

“The close working relationship between the U.S. Department of State’s Diplomatic Security Service, the FBI and the U.S. Attorney’s Office resulted in the conviction of Bryan Underwood before he could potentially harm the security of our country,” said Director Starr of the Diplomatic Security Service. “This was a great success by all of the agencies involved.”

According to court documents, from November 2009 to August 2011, Underwood worked as a cleared American guard (CAG) at the site of a new U.S. consulate compound that was under construction in Guangzhou, China. During this time, the compound was not yet operational. CAGs are American civilian security guards with top secret clearances who serve to prevent foreign governments from improperly obtaining sensitive or classified information from the construction site. Underwood received briefings on how to handle and protect classified information as well as briefings and instructions on security protocols for the U.S. Consulate, including the prohibition on photography in certain areas of the consulate.

In February 2011, Underwood was asked by U.S. law enforcement to assist in a project at the consulate and he agreed. In March and April of 2011, Underwood lost a substantial amount of money in the stock market. According to court documents, Underwood then devised a plan to use his assistance to U.S. law enforcement as a “cover” for making contact with the Chinese government. According to his subsequent statements to U.S. law enforcement, Underwood intended to sell his information about and access to the U.S. Consulate to the Chinese MSS for $3 million to $5 million. If any U.S. personnel caught him, he planned to falsely claim he was assisting U.S. law enforcement.

As part of his plan, Underwood wrote a letter to the Chinese MSS, expressing his “interest in initiating a business arrangement with your offices” and stating, “I know I have information and skills that would be beneficial to your offices [sic] goals. And I know your office can assist me in my financial endeavors.” According to court documents, Underwood attempted to deliver this letter to the offices of the Chinese MSS in Guangzhou, but was turned away by a guard who declined to accept the letter. Underwood then left the letter in the open in his apartment hoping that the Chinese MSS would find it, as he believed the MSS routinely conducted searches of apartments occupied by Americans.

In May 2011, Underwood secreted a camera into the new U.S. consulate compound and took photographs of a restricted building and its contents. Several of these photographs depict areas or information classified at the Secret level. Underwood also created a schematic that listed all security upgrades to the U.S. consulate and drew a diagram of the surveillance camera locations at the consulate. In addition, according to his subsequent statements to U.S. law enforcement, Underwood “mentally” constructed a plan in which the MSS could gain undetected access to a building at the U.S. consulate to install listening devices or other technical penetrations.

According to court documents, the photographs Underwood took were reviewed by an expert at the State Department’s Bureau of Diplomatic Security who had original classification authority for facilities, security and countermeasures at the U.S. Consulate. The expert determined that several of the photographs contained images classified at the Secret level and that disclosure of such material could potentially cause serious damage to the United States.

In early August 2011, Underwood was interviewed several times by FBI and Diplomatic Security agents, during which he admitted making efforts to contact the Chinese MSS, but falsely claimed that he took these actions to assist U.S. law enforcement. On Aug. 19, 2011, Underwood was again interviewed by law enforcement agents and he admitted that he planned to sell photos, information and access to the U.S. Consulate in Guangzhou to the Chinese MSS for his personal financial gain.

After initially being arraigned in this case on Sept. 1, 2011, Underwood was released on his personal recognizance, with certain conditions, including staying within the Washington, D.C. metropolitan area and returning to court for a status hearing on Sept. 21, 2011. Instead of returning to court as promised, Underwood purchased a bicycle, racks, panniers, helmet and multiple energy snack bars. He left a fake suicide note at his hotel room in Springfield, Va. Then, alive and well, he pedaled west out of Springfield and eventually boarded a bus in Wytheville, Va., under a false name. He was arrested on Sept. 24, 2011 in a hotel room in Los Angeles, with over $10,000 in cash and 80,000 Japanese yen. He has been in custody ever since.

The U.S. government has found no evidence that Underwood succeeded in passing classified information concerning the U.S. Consulate in Guangzhou to anyone at the Chinese MSS.

This investigation was conducted jointly by the FBI’s Washington Field Office and the State Department’s Bureau of Diplomatic Security. The prosecution was handled by the U.S. Attorney’s Office for the District of Columbia and Trial Attorney Brandon L. Van Grack from the Counterespionage Section of the Justice Department’s National Security Division.

Young pianist soars with a perfect 100: James
In January, while the media focus on Jamaican youth was all about violence, Rashaan Allwood was out stunning the world of classical music.
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RICHARD LAUTENS / TORONTO STAR
At 18, Rashaan Allwood, pictured in his parents’ living room in Mississauga, is already a piano phenom. The first-year U of T music student recently added a National Gold Medal from the Royal Conservatory for scoring 100 points on piano performance in January, the tops in Canada. He also won 3 categories at the Kiwanis music competition last week.

By: Royson James City Columnist, Published on Tue Mar 05 2013
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Even for a rare piano talent who has won medals at every level since 2002, this performance at the highest level of the Royal Conservatory was astonishing.
Rashaan Allwood, 18, played through a one-hour piano exam of baroque, classical, romantic, impressionist and 20th century music with such panache and precision that enthralled adjudicators gave him a perfect score.
Allwood’s “perfect 100” set the music fraternity abuzz in January, when he received the national gold medal as Canada’s top student sitting an exam for the world-renowned Associate of the Royal Conservatory of Toronto (ARCT) diploma.
The first-year University of Toronto piano performance student even surprised himself with what a conservatory spokesman calls a “very, very, very rare” achievement.
“When I saw the score I didn’t believe it, so I called them to confirm it,” Allwood told the Star. “It seemed unfathomable.”
The conservatory, which holds 100,000 exams a year, confirmed his brilliance.
“It felt really, really amazing,” said the Mississauga resident. “I think they were saying, ‘You have the potential to be really, really good. This is our way of giving you a boost.’ It’s something to encourage me to work even harder than before; not to be cocky.”
The honour confirmed everything Filmore Allwood and wife Joyce envisioned for their son, and brother Yannick, since the parents immigrated here from Jamaica.
Be a strong dad. Watch over the children like a hawk. Provide unstinting support. Set high goals. Watch them soar.
But even as Rashaan received his gold medal at Koerner Hall on Bloor St., on Jan. 13, a new wave of gun crime was about to wash over the GTA — eclipsing the achievement of the majority of black youth, amazing ones like Rashaan’s, and the everyday success of the majority of others.
“I am hoping this will make an impact on the youths of our community, to inspire them to achieve to be the best in whatever they want to be,” the dad wrote in an email late January, requesting news coverage.
Most media were preoccupied with the shooting death of 15-year-old Tyson Bailey on Jan. 18, Kesean Williams, 9, five days later; and St. Aubyn Rodney, 15, on Feb. 11.
By the end of February, Dad had given up.
“I fully understand the situation,” he wrote. “This would have been recognized as news if my son was involved in crime or drugs. Then we wouldn’t have enough room on our driveway for cameras and journalists.
“I guess my son has found himself in a field where ‘he does not belong’ because of his ethnicity (he is not white or Asian).”
The words cut, with a ring of truth.
Pulling away from the daily dose of Rob Ford nonsense, I attended Rashaan’s performance at the 70th annual Toronto Kiwanis Music Festival last week. He entered three categories: Chopin, Bach and Beethoven. He won them all.
“One step above everyone,” was just one of many accolades delivered by adjudicator, acclaimed pianist Jean Desmarais.
Rashaan’s performance of Chopin’s Fantasy in F Minor broke new ground, Desmarais said. He had never envisioned the composition could be played that way but, not only did Rashaan do it, he “convinced me.”
“He’s going to be a star,” said audience member Ann Luu, watching the Kiwanis performance with more than casual interest. She’d donated a scholarship to the winner and was ecstatic at what she’d heard.
Rashaan and Yannick started piano lessons about 12 years ago. (Yannick is studying piano performance and actuarial science at University of Western Ontario. Rashaan received a full scholarship and wants to become a concert pianist and music teacher.)
Teacher Anna Fomina has taught hundreds of students in Moscow and the Mississauga School of Music over 40 years. “Rashaan is the most talented,” she says.
He lives the music, embodies it and makes it his own. And he’s not afraid to capture the emotion of a composition and deliver it to the heart of the listener.
“Most students have talent, but they understand the music with their head so they play like a computer, a machine; Rashaan feels with his heart, so he touches people’s hearts,” says Fomina.
Rashaan credits this to the effort he takes to understanding what the composer was going through as he created the music. The technical skills honed over a grueling practice regimen — he’s at U of T at 7 a.m. most days and doesn’t get home till late — are important in that they allow him the freedom to inhabit the musical score without being distracted by technical obstacles.
His gold medal performance demanded he play five works of contrasting styles. For an hour he played Bach, Beethoven, Chopin, Ravel and Prokofiev, plus Russian composer Moszkowski.
The two adjudicators thanked him for his “uninterrupted excitement” and “virtuosic fluency.”
“Your abundant musical talent allowed you to surpass the technical and musical challenges which were presented to you in this very fine, challenging program. We enjoyed hearing you and wish you the best in your continued studies.”
Fomina says Rashaan’s achievements are at least 50 per cent his father’s doing.
He often sits through Rashaan’s lessons. He would hear what Fomina demanded of Rashaan and reinforce it at home. Most parents expect the one hour of music lesson to create genius. Rashaan’s dad didn’t leave it to the teacher — not with a musical discipline that is more demanding than regular homework from school, she says.
He surrounded him with all kinds of music, including European classical recordings — a fact that helped him develop an appreciation for all kinds of music and a love of Bach.
Not surprisingly, Filmore Allwood has lots to say about rearing children and what it takes to keep them out of trouble and away from the influences of the street.
One key solution to street violence “comes right back to parenthood,” he says. “You pay attention and see the kid is volunteering and excelling. You have to be there, help the child, make sure he’s involved in community service, learns to respect his peers, relatives and friends.
“If you don’t have those things and teach the child, you will have problems. The child must be able to express himself, have a conversation. And the best place to have a good conversation is at the dinner table. You have to make sure you have something to impart every day. You can’t stop. So, when the child goes out, he will remember what the parent said and that will prevent him from doing bad things.
“They go to school and hear hundreds of things and many voices, including their peers. Where is your voice?
“You have to give it when they wake up and when they go to sleep. If you don’t, you have the problems we have on the streets. Go to any parent whose kids are doing good — see how much effort they put into it.”
And, he says, institutions like the church must step into the gap where parents are missing.
Rashaan and his brother found their early love for music in the church. Both played roles as Young Simba in the Mirvish production of Lion King. Rashaan plays at numerous community events with his jazz band. And he’s adopted a school in St. Elizabeth, Jamaica, sending money he earned from awards to repair the school.
With a strong sense of his identity, Rashaan says he is not deterred by the lack of African-Canadians in his music circle.
“You don’t usually see them in competition. People are surprised to see me doing well, because it’s not something black people really do.
“It feels good because, really, it doesn’t matter what colour your skin is. Music is music. You don’t have to be Russian or German or Italian or Asian to do classical music. It comes from the soul. It all comes from the soul, and we all have a soul.”
Royson James usually appears Tuesday, Thursday and Saturday. Email: [email protected]

() — George Zimmerman’s attorneys say they’re abandoning their pretrial attempts to argue he’s immune from prosecution in the 2012 shooting death of Trayvon Martin, contending they don’t have time to prepare for that and the trial.
Zimmerman, charged with second-degree murder, says he shot the 17-year-old in self-defense after he saw the young man acting suspiciously in his neighborhood in Sanford, Florida. An April 22 hearing had been expected to determine whether Florida’s self-defense laws shielded him from prosecution.
But Zimmerman attorney Mark O’Mara told a judge Tuesday that he didn’t need time in April for pretrial motions. He told reporters that he still could file a motion for immunity when the trial begins June 10, or later if a civil case arises. But O’Mara indicated that with the jury trial about three months away, it was time to prepare primarily to get Zimmerman acquitted through that venue.
“We don’t have time … to spend two weeks or so” on an immunity hearing, O’Mara said outside a Sanford court Tuesday morning.
“Our focus is to get him to a jury and get acquitted,” he added.

See the boy here wah the girl a canada nuh stop tek fi fool she mussi call him pb pan fbook but all because him hear farin gal n him musii love likes . Gal seh when she cyaa get r man ova ya fi f%$k in which dat a my cous in law she jus video call him n she finger rself and him back him fist llol lol lol she claim she nuh bady nuh luv f%ck like she lol lol before him go look a gal f&ck lool cause him mus have him woman otherwise but a so it go wen u well wah rch a farin u do all type a tings and tun clown the gal ova ya sneeking n wild like ne wild animal young likkle galang coming like a wolf inna sheep clothes inna basement
Anything me talk a nuh lie
Am a proud canada n nuh bagga man name na call pan mi as old as mi be ntn nuh hide ova ya

Title: yuh nah stop wear di dem woman clothes

Message Body:
england village idiot jah know duh better,duh better mi beg yuh!!

P.A. Benjamin Manufacturing Co., Ltd. 1/29/13

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993

Warning Letter

CERTIFIED MAIL WL: 320-13-07
RETURN RECEIPT REQUESTED

January 29, 2013

Mr. Errol L.G. Powell
Chairman
P.A. Benjamin Manufacturing Co., Ltd.
95-97 East Street
Kingston, Jamaica

Dear Mr. Powell:

During our May 5 through 11, 2012, inspection of your pharmaceutical manufacturing facility, P.A. Benjamin Manufacturing Co., Ltd., located at 95-97 East Street, Kingston, Jamaica, investigator(s) from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have conducted a detailed review of your firm’s response of May 24, 2012, and note that it lacks sufficient corrective actions.

Our investigator(s) observed specific violations during the inspection, including, but not limited to, the following:

CGMP VIOLATIONS
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Two examples of this violation include:

Lot #JU83 of Infant Gripe Mix failed the pH specification. The range was (b)(4) to (b)(4), whereas the result recorded in the batch record was (b)(4).
Lot # KM40 of Diphenhydramine Expectorant failed specific gravity and (b)(4). The results for specific gravity and (b)(4) were (b)(4) and (b)(4), whereas the acceptable ranges were (b)(4)-(b)(4) and (b)(4)-(b)(4), respectively.

You conducted no investigation for these failures, yet you released these lots for distribution. The quality assurance manager stated that the specification failures did not impact the therapeutic activity of the drug products but provided no evidence to support this conclusion. In your response to this letter, provide your investigation into these failures and the action plan regarding failed batches that are within expiry and currently in U.S. distribution.

In addition, please provide a detailed description of the changes and improvements made to your investigation procedures.

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products (21 CFR 211.22(a)).

Two examples of this violation include:

a. The quality unit (QU) failed to review or approve drug product production batch records before release and distribution of your products. For example, your firm released for distribution lot #JM11 of Infant Gripe Mixture and lot #JS17 of Benjamins Cough and Cold, notwithstanding the fact that your QU did not provide review of multiple corrections of documentation errors.

b. Your quality unit failed to review and approve multiple changes your firm made to the manufacturing processes. For example, during the manufacture of lot # KM 40 of Diphenhydramine Expectorant, your firm added (b)(4) to the bulk tank. This step was not in the master batch record and your QU did not review or approve these changes.

In your response to this letter, please include a detailed plan on how your quality unit will provide consistent, adequate review and approval of investigations and production batch records. Include a list of all responsibilities assigned to the quality unit.

Your firm failed to conduct at least one specific identity test on a component when relying on that component supplier’s analysis (21 CFR 211.84(d)(2)).

For example, your firm released raw materials, including glycerin, (b)(4), (b)(4), and (b)(4), relying only on the certificates of analysis. The performance of identity testing on each incoming ingredient lot is a fundamental part of good manufacturing practice. An incoming lot cannot be accepted based on the identification test result listed on a vendor’s certificate of analysis. In particular, glycerin and (b)(4) are vulnerable to intentional adulteration and incoming lots should be afforded special quality control scrutiny prior to a lot disposition decision for use in manufacturing. For more guidance, see Testing for Glycerin for Diethylene Glycol (May, 2007) at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070347.pdf.

In your response to this letter, describe in detail your raw material testing program, including how you will ensure that raw materials used in the manufacture of your drug products will be withheld from use unless the lot has been tested or examined in accordance with the current USP/NF and released for use by the quality control unit. In addition, describe your vendor qualification program and your procedures to periodically verify each vendor’s full certificate of analyses.

Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

For example, your firm lacks written approved procedures to prevent microbial contamination during the manufacturing operations of over-the-counter (OTC) drug products at your facility. Additionally, there was no evidence that your firm tested finished drug products for microbial limits. For example, your firm did not perform total aerobic microbial count (TAMC) and total combined yeast and mold counts (TYMC) to ensure a low bioburden.

In your response to the inspectional observations, you acknowledged a need to develop validated and approved procedures to prevent microbial contamination during manufacturing. However, you did not describe these procedures, nor did you describe your plans for testing microbial quality of raw materials, in-process intermediates, and finished products.

We are concerned about your firm’s failure to assure appropriate microbial quality of the drug products shipped to the U.S. market. For example, some of your products are to be given orally to infants and they have not been tested for microbial contamination. Provide a risk assessment of all the drug products that remain within expiration in U.S. distribution, as well as an action plan to ensure that the products released for distribution are free of objectionable contamination.

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

For example, your firm failed to validate a cleaning method used for the multi-product manufacturing equipment and utensils. Your firm has no assurance that your current, manual cleaning methods are effective in removing residues of drug products and detergents from the manufacturing equipment and utensils. Additionally, your firm failed to validate the “(b)(4)” device used to detect (b)(4) traces on the equipment surfaces after cleaning. Finally, your firm failed to implement procedures on the proper use of the device.

In your response, you acknowledged your failure to implement and record the validation of your firm’s cleaning processes. Your response is inadequate because it did not include a plan to implement cleaning procedures to ensure that drug product residues and cleaning agents are removed adequately. In your response to this letter, please provide your updated cleaning procedures, protocols for demonstrating that these procedures are effective, and reasonable timelines for executing these protocols. If you choose to continue manufacturing prior to completion of the cleaning validation, submit the acceptance criteria you will use for cleaning verification. You should also include your evaluation of the potential for cross-contamination of products currently in distribution in U.S. due to inadequate cleaning. During our next inspection, we will confirm proper qualification of equipment as well as suitability of test methods.

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

Specifically, your firm has not validated the manufacturing processes for the OTC drug products, Diphenhydramine Elixir, Diphenhydramine Expectorant, and Infant Gripe Mix. In addition, you reprocessed several batches of these products without approval by the Quality Unit and without assessing the impact of the changes on the quality of the product.

In your response, you should include validation plans for the production and process control procedures you use in the manufacture of drug products intended for U.S. distribution. Additionally, include a revised master batch record and procedure for reprocessing batches after quality unit approval.

Validated processes help ensure that your products are manufactured reproducibly, master batch records are adequate, and variability is controlled to prevent batch failures. Additionally, monitoring of process performance and product quality throughout the process validation lifecycle provides opportunities to improve control of your manufacturing processes and the quality of your products.

The items listed above, as well as other deficiencies found by our investigator, lead us to question the effectiveness of your current quality system to achieve overall compliance with CGMP at your facility. It is essential that your firm implement a robust quality system. We remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements, including the CGMP regulations. FDA strongly recommends that your firm’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements. We also recommend that you hire a qualified consultant to provide your firm’s staff with CGMP guidance and training on GMPs and particularly the responsibilities and procedures applicable to the quality unit.

UNAPPROVED NEW DRUG AND MISBRANDING VIOLATIONS

In addition to violating CGMPs, Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, Benjamins Cold and Cough and Benjamins Infants Gripe Mixture are OTC products that violate the unapproved new drug and misbranding provisions of the Act. As described in more detail below, these products are unapproved “new drugs” in violation of section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition , Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are also all misbranded under 502(f)(2) the Act [21 U.S.C. § 352 (f)(2)] and Benjamins Flu Relief is further misbranded under Section 502(c) of the Act [21 U.S.C: § 352(c)].

According to the labeling for Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough these products are drugs within the meaning of Section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the diagnosis, treatment, or prevention of disease, and under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or function of the body.

Furthermore, the products are intended for purposes that include as an antihistamine, expectorant, antitussive and/or decongestant and include uses for addressing cough cold symptoms. In order for OTC antihistamine, expectorant, antitussive, decongestant or other related cough cold products to be generally recognized as safe and effective and not misbranded, and thus be marketed without an approved NDA, they must meet the requirements of the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341. Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are unapproved new drugs because they do not meet this final monograph and are not otherwise covered by an FDA-approved application.

Among the violations for these products, the labeled directions for use for these products do not comply with the directions for use set forth under the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341. For example, Benjamins Flu Relief, Benjamins Sinus, and Benjamins Cough and Cold contain dosing directions for children down to one year of age when the final monograph provides that one should consult a doctor for children under two. Furthermore, Benjamins Diphenhydramine Expectorant contains dosing directions for children down to the age of three and Benjamins Diphenhydramine Elixir contains dosing directions down to the age of two years when the final monograph provides that one should consult a doctor for children under six years of age for antihistamine containing drug products.

In addition, Benjamins Diphenhydramine Expectorant and Benjamins Cough and Cold contain active ingredients that do not comply with the final monograph, such as (b)(4) and (b)(4). Furthermore, Benjamins Flu Relief and Benjamins Cough and Cold contain indications that do not comply with the final monograph, such as (b)(4) and (b)(4), respectively.

Thus, as formulated and labeled, Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are not generally recognized as safe and effective for the indications described in their labeling, and therefore, are new drugs under section 201(p) of the Act [21 U.S.C. § 321 (p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application. Your firm’s marketing of Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough without FDA-approved applications violates this provision of the Act.

The products Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are also all misbranded under 502(f)(2) the Act because the products’ labeling fails to bear all of the required warnings described in the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341 for each declared active ingredient. Benjamins Flu Relief and Benjamins Sinus are also misbranded under section 502(f)(2) of the Federal Food, Drug and Cosmetic Act (the Act) because the products’ labeling does not comply with FDA’s organ specific labeling regulation for acetaminophen containing OTC drug products. Specifically, they do not include the required liver warning information described 21 C.F.R. § 201.326(a)(1)(iv). Please note that this warning is required to be on both outer and immediate container labeling if there is both an outer and immediate container.

Benjamins Flu Relief is also not labeled in accordance with the “Drug Facts” labeling requirements described in 21 C.F.R. § 201.66. Therefore, this product is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)], because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. Therefore, the marketing of Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough violates this provision of the Act.

Furthermore, the product Benjamins Infants Gripe Mixture as formulated and labeled is an OTC drug. The product contains a combination of active ingredients and indications that are not covered under FDA’s OTC Drug Review, which establishes conditions for general recognition of safety and effectiveness for OTC drugs. Furthermore, we are not aware of a product with your formulation and labeling otherwise being eligible for the OTC Drug Review nor are we aware of any evidence establishing that a product as formulated and labeled as Benjamins Infants Gripe Mixture is generally recognized as safe and effective for the described indications. Therefore, Benjamins Infants Gripe Mixture is a new drug under section 201(p) of the Act [21 U.S.C. § 321 (p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.

Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Benjamin Manufacturing Co., Ltd., located at 95-97 East Street, Kingston, Jamaica, into the United States. The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the drug product(s) at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3004341688.

Please send your reply to:

Allison A. Aldridge, Ph.D.
Compliance Officer
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 2258
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0483
Fax: (301) 847-8741