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“Hi-Health:Ocular Nutrition” Dietary Supplement Fined $450,000 Part 2

“Hi-Health:Ocular Nutrition” Dietary Supplement Fined $450,000 Part 2 continued from Part 1

“Hi-Health: Ocular Nutrition” Dietary Supplement Fined $450,000 Part 2 continued from Part 1

If you have not read Part 1 yet read it now. Basically Hi-Health made unsubstantiated claims that their formula was able to repair damage from age-related macular degeneration. Their marketing plan used a well know spokesman, known for telling the truth to pass along their advertising. This became known as “paul harvey ocular nutrition” or “Paul Harvey’s Premier formula for Ocular Nutrition”.

As I mentioned in the previous post I am very fond of Paul Harvey and his radio program. I believe these unscrupulous business people used him and the weight of Paul’s radio show. This did work very well for hi-health, Paul Harvey does his job very well and there are still people looking for this formula.

“The FTC’s complaint alleged that the Hi-Health made unsubstantiated claims that their Premier Ocular Nutrition formula ‘restores vision lost from age-related macular degeneration and eliminates floaters’, and falsely claimed that nutritional studies in responsible medical journals confirm that the ingredients available in Ocular Nutrition may help individuals with cataracts and/or floaters.”

Now according to the FTC, there are no nutritional studies in responsible medical journals that confirm the respondents’ claims. According to the complaint, and a statement issued by the National Eye Institute, verified this as well.

Yet there is more…

Click the Paul Harvey Ocular Nutrition & Hi-Health Part 2 for some of the actual script of the ads very strong marketing you have to read this.

AREDS Formula for Ocular Nutrition

AREDS Formula for Ocular Nutrition

Age Related Eye Disease Study (AREDS) Formula for Ocular Nutrition

The National Eye Institute division of National Institute of Health released this information about how certain antioxidants, Vitamins and Zinc Reduce Risk of Vision Loss from Age-Related Macular Degeneration.

Scientists found that people at high risk of developing advanced stages of AMD, a leading cause of vision loss, lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc.

Another high risk group reduced their risk 19%.

The clinical trial — called the Age-Related Eye Disease Study (AREDS) — was sponsored by the National Eye Institute (NEI), one of the Federal government’s National Institutes of Health.

“The nutrients are not a cure for AMD, nor will they restore vision already lost from the disease,” Dr. Sieving said. “But they will play a key role in helping people at high risk for developing advanced AMD keep their vision.”

For more information on AREDS formula used in the study, the treatment and more specifics on how AREDS became one of the foundational building blocks to Ocular Nutrition and the Eye Vitamin industry see this AREDS page.

“Hi-Health:Ocular Nutrition” Dietary Supplement Fined $450,000

“Hi-Health:Ocular Nutrition” Dietary Supplement Fined $450,000

“Hi-Health:Ocular Nutrition” Dietary Supplement Fined $450,000 – Part 1

Here’s the post I promised when I stated “In a future post I will reference what happened to one company that was overzealous in their claims.” here AMD Cured.

Hi-Health Supermart Corp and its owner Simon Chaplin ended up settling with the FTC (Federal Trade Commission) after making unsubstantiated claims about “Premier Formula for Ocular Nutrition-Optima 3 (Ocular Nutrition).

Their claims were:
1) Their Ocular Nutrition Formula could restore vision already lost from age-related macular degeneration.
2) And eliminate floaters (small specks moving in the field of vision).

The FTC Administrative Consent Agreement banned the respondents from these specific claims of their ocular nutrition or any similar supplement. That is unless they had competent and reliable scientific evidence to support their claims. It also required the $450,000 to be paid to the FTC.

Read more here at Paul Harvey Ocular Nutrition

More Ocular Nutrition Evidence

More Ocular Nutrition Evidence

AMD Risk Reduction 34%

A new 2007 study by William G. Christen, PhD, resulted in reduced risk of confirmed age-related macular degeneration by 34 percent.

The study contained women age 40 and above and was randomized study. These ladies had or were at high risk for cardiovascular disease.

The study was “The Women’s Antioxidant Folic Acid Cardiovascular Study” and found that the combination of folic acid, vitamin B6 and vitamin B12 (great ocular nutrition – eye vitamin ingredients) reduced the risk of confirmed age-related macular degeneration at the thirty-four percent rate.

It also showed to reduce the risk of visually significant AMD by 41 percent over seven years of treatment and follow-up.

I’ve read about vitamin B6 and vitamin B12 but this is the first article I have read about folic acid being used in a study and regarded as another possible ocular nutrient.

REFERENCE

Christen WG, Glynn RJ, Chew EY, Manson JE. Folic acid plus B-vitamins and age-related macular degeneration in a randomized trial in women. Abstract 1152. Paper presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO); May 7, 2007; Fort Lauderdale, FL.

Dry AMD Cured?

Dry AMD Cured?

Dry AMD Cured?
While researching writings by Benjamin Caballero at Johns Hopkins University.1 I was reminded of a major change affecting the Federal Food, Drug, and Cosmetic Act of 1958—FD&C Act (FDA) that occurred in 1994.

Dietary supplements were under the regulatory authority of the FDA prior to 94. However, the Dietary Supplements Health and Education Act (DSHEA) removed the FDA’s authority over dietary supplements by excluding them.

With those provisions, dietary ingredients used in dietary supplements are no longer subject to the pre-market safety evaluations required of other new foods (and medications).

After a product is marketed the FDA must show that a dietary supplement is “unsafe,” before it can take action to restrict, or remove the product from the marketplace.

Caution must be taken by the consumer to read carefully what retailers state on their websites, and marketing materials for supplements, vitamins and nutrients.

It is illegal to state that their products “cure”. Evidence and scientific studies must prove and be documented and recognized by the FDA for marketing materials that talk of a cure.

In a future post I will reference what happened to one company that was overzealous in their claims.

1 Shils ME, Shike M, Ross AC, Caballero B, Cousins RJ. Modern Nutrition in Health and Disease. Philadelphia: Lippincott, 2005.

A link to Professor B Caballero

Link to FDA