Public Relation Assignment WK 2

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MUST BE 100% PLAGARISM FREE, APA STYLE FORMAT, ARTICLE IS DOWN BELOW

 

 

 

 

Intro to Quality Week 2

 

Product Recall

 

Review the article “USPlabs Recalls OxyElite Pro Supplements Amid Links to Liver Illness” which can be found in your weekly reading. This article pertains to a recall of a popular health supplement. Assume you are the manager for the OxyElite Pro supplement. How can you use focus groups and surveys to determine your customer’s feelings about their products despite the recall that has occurred? Use your course materials and outside research to generate a solid analysis on why these methods would be helpful. Your analysis should be supported by research.

 

READING

 

USPlabs Recalls OxyElite Pro

 

Supplements Amid Links

 

to Liver Illness

 

Dallas, TX-based USPlabs LLC has recalled

 

certain OxyElite Pro dietary supplement

 

products that the company markets after

 

receiving a letter from FDA stating that the

 

products have been linked to liver illnesses

 

and that there is a reasonable probability

 

that the products are adulterated.

 

The letter also notifi ed USPlabs that if

 

the company did not initiate a voluntary

 

recall, FDA could by law order the company

 

to immediately stop distributing the

 

products and immediately notify other

 

parties to stop distributing the supplements.

 

The action marks the second time

 

the FDA has exercised its recall authority

 

under the FDA Food Safety Modernization

 

Act (FSMA) by sending such a letter.

 

“We took this step to ensure that adulterated

 

and harmful products do not reach

 

the American public,” said Deputy Commissioner

 

for Foods and Veterinary Medicine

 

Michael Taylor. “We will continue to

 

work with our state, industry and regulatory

 

partners to prevent such products

 

from reaching the public.”

 

By letter dated Nov. 6, the FDA notifi ed

 

USPlabs about fi ndings indicating a link

 

between the use of several OxyElite Pro

 

products and a number of liver illnesses

 

reported in Hawaii. The FDA also noted

 

that cases of liver damage after use of these

 

OxyElite Pro products had been found in

 

a number of other states. In a review of 46

 

medical records submitted to the FDA by

 

the Hawaii Department of Health, the records

 

indicated that 27 patients, or 58%,

 

had taken a dietary supplement labeled as

 

OxyElite Pro prior to becoming ill. Seventeen

 

of the 27 patients (or 63%) reported

 

that OxyElite Pro was the only dietary

 

supplement they were taking. At least one

 

death has occurred among these patients,

 

and others required liver transplant.

 

In a warning letter issued to USPlabs

 

LLC on Oct. 11, 2013, the FDA informed

 

the company that OxyElite Pro and another

 

dietary supplement called VERSA-1

 

were deemed to be adulterated. The products

 

contained aegeline, a new dietary ingredient

 

(i.e., an ingredient not marketed

 

in the U.S. before Oct. 15, 1994) that lacks

 

“We will continue to work with our state,

 

industry and regulatory partners to prevent

 

such products from reaching the public.”

 

—Michael Taylor, FDA, on USPlabs recall

 

Global Sales of Non-GMO Food and

 

Beverages to Reach $800 Billion by 2017

 

Non-GMO products will account for about 15% of total

 

global food and beverage sales.

 

Global sales of non-GMO food and beverages are projected to rise

 

to $800 billion by 2017 at a compound annual growth rate (CAGR) of

 

15%, and will account for about 15% of total global food and beverage

 

sales at that point, according to Packaged Facts’ recently released

 

report, “Non-GMO Foods: Global Market Perspective.” Global

 

sales of non-GMO products reached $400 billion in 2012, accounting

 

for 8% of the overall global food and beverage sales of $5 trillion.

 

Excluding the U.S. and Canada, Packaged Facts identifi ed 10

 

countries that represent as much as two-thirds of the new global non-

 

GMO product introductions from 2009-2013. Russia is the leader with

 

15% share, followed by the U.K. with a share of 10%. From a comprehensive

 

global perspective, the U.S. share is roughly 40%. Aside from

 

the U.S. and Canada, Europe represents seven in 10 global non-GMO

 

food and beverage rollouts between 2009 and 2013. Europe is followed

 

at a considerable distance by Asia and Oceania.

 

Packaged Facts projected that non-GMO sales will increase in

 

all regions of the globe, as will the practice of labeling foods and

 

beverages with non-GMO verifi ed or certifi ed labels. Prompting

 

increases will be the inevitable expansion of GMO crops into territories

 

where they had previously been banned or limited. Concerned

 

shoppers will want GMO and non-GMO labeling to help

 

them distinguish between the two types of products. The BRIC

 

nations—Brazil, Russia, India and China—will be fertile territory for

 

non-GMO sales as their emerging middle classes look for healthier

 

eating options, according to David Sprinkle, research director for

 

Packaged Facts.

 

As other nations seek to clarify the labeling of their products,

 

both GMO and non-GMO, Packaged Facts projected the portion

 

of the global non-GMO market represented by sales in the U.S.

 

will decline through 2017. In addition, non-GMO labeling will become

 

more available as certifi ed testing operations, like NSF International,

 

join Cert ID in the non-GMO verifi cation market to take

 

advantage of a growing demand from marketers.

 

Non-GMO labeling will become more available as

 

certifi ed testing operations

 

join the verifi cation market.

 

16-31IndustryNews1213.indd 16 11/26/13 3:40 PM

 

Industry News

 

18 • Nutraceuticals World www.nutraceuticalsworld.com December 2013

 

a history of use or other evidence of safety.

 

The letter stated that failure to immediately

 

cease distribution of all dietary supplements

 

containing aegeline may result in

 

enforcement action.

 

U.S. Marshals Seize

 

Adulterated Supplements

 

Worth More Than $2 Million

 

At the request of FDA, U.S. Marshals

 

seized dietary supplements manufactured

 

and held by Hi-Tech Pharmaceuticals, Inc.,

 

located in Norcross, GA, after agency investigators

 

found the products contained

 

1, 3-Dimethylamylamine HCl (DMAA) or

 

its chemical equivalent in early November.

 

The retail value of the seized products is

 

more than $2 million.

 

A complaint fi led in the U.S. District

 

Court for the Northern District of Georgia

 

alleged that the products were adulterated

 

according to the Federal Food, Drug,

 

and Cosmetic Act because they contain

 

DMAA, an unapproved food additive that

 

is deemed unsafe under the law.

 

DMAA can elevate blood pressure and

 

could lead to cardiovascular problems, including

 

heart attack, shortness of breath

 

and tightening of the chest. Given the

 

known biological activity of DMAA, the

 

ingredient may be particularly dangerous

 

when used with caffeine. The FDA has

 

warned consumers about the health risks

 

of DMAA on its website.

 

On Nov. 12, U.S. Marshals seized more

 

than 1,500 cases of fi nished goods and

 

more than 1,200 pounds of in-process/raw

 

material goods from the Hi-Tech Pharmaceuticals,

 

Inc. facility.

 

“This company has a responsibility to

 

ensure its products are safe for distribution

 

and human consumption,” said Melinda

 

Plaisier, the FDA’s associate commissioner

 

for regulatory affairs. “We have taken action

 

to protect consumers and demon-

 

Trade Groups Defend Supplement Use

 

Following Multivitamin Review

 

Meta-analysis concludes more research needed on use of

 

vitamin/mineral supplements for CVD and cancer prevention.

 

A systematic review of published studies

 

found insuffi cient evidence that vitamin and

 

mineral supplements are effective for preventing

 

cardiovascular disease (CVD), cancer

 

or mortality from those diseases in healthy

 

adults, according to an article published in

 

Annals of Internal Medicine.

 

Two studies included in the review found

 

lower overall cancer incidence in men who

 

took a multivitamin for more than 10 years.

 

Those same studies showed no cancer protection benefi t for women.

 

Researchers cautioned that more research is needed before it

 

can be determined whether or not multivitamin supplementation

 

is benefi cial.

 

The evidence review was conducted by researchers for the U.S.

 

Preventive Services Task Force (USPSTF) to update its previous recommendation.

 

In 2003, the USPSTF found insuffi cient evidence to

 

recommend for or against the use of vitamins A, C and E, multivitamins

 

with folic acid or antioxidant combinations for the prevention

 

of CVD or cancer. At the time, the USPSTF recommended against

 

beta-carotene supplements alone or in combination with other supplements

 

because they had no benefi t and actually harmed patients

 

at risk for lung cancer. The current research review reconfi rmed the

 

beta-carotene fi ndings and also found good evidence that vitamin E

 

does not protect against cancer or cardiovascular disease.

 

In response to the review, industry trade associations offered

 

their analysis.

 

“Cancer is a complex disease, and the fact that there is even

 

some, albeit limited, evidence that a simple multivitamin could

 

prevent cancer demonstrates promise and should give consumers

 

added incentive to keep taking their multivitamins,” said Duffy

 

MacKay, ND, vice president, scientifi c and regulatory affairs, Council

 

for Responsible Nutrition (CRN), Washington, D.C. “We believe

 

the paucity of clinical trial evidence should not be misinterpreted as

 

a lack of benefi t for the multivitamin. We know for sure that multivitamins

 

can fi ll nutrient gaps, and as so many people are not even

 

reaching the recommended dietary allowances for many nutrients,

 

that’s reason enough to add an affordable

 

and convenient multivitamin to their diets.

 

“Further, given the encouraging results

 

from the Physicians’ Health Study (PHS) II

 

(Gaziano et al, 2012)—the study referenced in

 

this report as demonstrating benefi t for multivitamins

 

and cancer risk in men—academics

 

and government, as well as our own industry,

 

should continue to support and fund research

 

to clarify this relationship and to determine additional

 

benefi ts for vitamins and other dietary supplements.

 

Cara Welch, PhD, senior vice president of scientifi c and regulatory

 

affairs, noted the scope of this recent research has its limitations.

 

“The meta-analysis focused on studies that researched

 

generally healthy people, avoiding any instances for targeted

 

use of nutrients. Additionally, the researchers only concentrated

 

on studies with vitamins and mineral supplements as the primary

 

source of prevention. Multivitamin supplements should not

 

be expected, without the combination of a healthy lifestyle, to

 

prevent chronic disease. The results of this review should not

 

lead to widespread concern among consumers who take vitamin

 

and mineral supplements.”

 

John Shaw, executive director, NPA, added, “Dietary supplements

 

are used by more than 150 million Americans on a daily

 

basis. Research has shown that when taken in combination with

 

other healthy lifestyle practices, such as consuming a wholesome

 

diet and exercising regularly, people can benefi t from dietary supplements.

 

Consumers should be comfortable following a variety of

 

healthy habits, which includes supplementation. As always, NPA

 

encourages consumers to speak with their healthcare professionals

 

regarding their dietary supplement regimen.”

 

More than 150 million Americans use dietary

 

supplements on a daily basis.

 

16-31IndustryNews1213.indd 18 11/26/13 3:40 PM

 

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