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FDA: Fair Fight?

FDA: Fair Fight?

July 7, 2011
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" The only way they’re going to slap their seal of approval on a product that’s not an actual pharmaceutical drug is if you go through the same trials that a pharmaceutical drug does, which costs millions of dollars and takes three to four years. "

In December, the Food and Drug Administration announced a crackdown on weight loss, bodybuilding and sexual enhancement supplements that contain potentially dangerous ingredients.

The FDA claimed that some manufacturers have deceptively labeled products, not mentioning ingredients that should only be available by prescription or are known to cause adverse health effects, and the agency posted a letter to the supplement industry saying that manufacturers who distribute tainted products could face criminal prosecution.

According to the Food and Drug Administration website, the FDA regulates dietary supplements using regulations that are different from regulations covering foods and drug products: “Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.”

DSHEA also compels the familiar warning, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease,” on supplement packages.

“With DSHEA, the government said, ‘We trust you,’” Ruth Chatfield, vice president of marketing and development and co-owner of M.D. Science Labs, told XBIZ.

“They said, ‘We won’t make you submit to us before you go to market. But you’re swearing when you go to market that you have in the bottle what is on the label — and only what is on the label.’ The problem is that people are putting in additional ingredients that aren’t on the label.

“We had the second product on the market after Viagra. I can compete against real Viagra, but it’s not a fair fight. Or real Levitra or real Cialis. And there have been 70 cheaters caught since 2003, with real drugs or an analogue of them. The weight-loss products tend to have prescription weight-loss drugs in there, and the bodybuilding products tend to have steroids.”

“The FDA doesn’t approve most neutraceutical products,” Julie Wilson, owner of Raw-Nation, told XBIZ. “Neutraceutical companies actually make the FDA lose money. The only way they’re going to slap their seal of approval on a product that’s not an actual pharmaceutical drug is if you go through the same trials that a pharmaceutical drug does, which costs millions of dollars and takes three to four years.

“What they [the FDA] do with the labs that they oversee is they constantly have an eyeball on them. They audit them all the time, they test the facility, they test the products. If they’re ever operating on a fishy manner, they get shut down.”

In March, distributor AVNS Inc. announced a voluntary recall of its The Best Enhancement Supplement after the manufacturer, Drive Total Energy, informed AVNS that FDA lab analyses found Sulfoaildenafil in the product, although it was not listed on the label. Sulfoaildenafil is an analogue of Sildenafil, an FDA-approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take prescription drugs to treat those conditions. Erectile Dysfunction is also a common problem in men with these conditions, and they may take non-prescription supplements to enhance sexual performance.

Sulfoaildenafil could interact with some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels, the company said.

AVNS Inc. and Drive Total Energy had not received any complaints from its customers, and were not aware of any reports made to the FDA concerning any adverse effects associated with the use of The Best. It is the position of AVNS that it did not in any way knowingly or intentionally violate the law with regard to the distribution of these products, the company said.

“We’ve never had any product pulled off the market in 12 years of business,” Chatfield said. “The only way that it has possibly affected us is that they are quarantining some of our raw materials. We import all our raw ingredients, and they’re testing them — or causing us to have them be tested — before they’re released from Customs. That’s delaying things three weeks to a month on each shipment.”

The delay means that M.D. Science Labs has to plan ahead in its manufacturing schedule, Chatfield said, and pointed out another problem with FDA interference:

“I sell to stores, and store owners tell me — they told me this at the [International] Lingerie Show, [in March] — that they are sick and tired of having a new herbal come on the market. ‘We put it up on our shelf, it sells, and then we go to buy it again and the FDA has pulled it off the shelf,’” Chatfield told XBIZ. “We don’t want to be involved with roller-coastering our customers. They’re sick of it.”

“Being certified organic, the FDA won’t come after us,” Wilson said. “We don’t make any false claims, and we’re certified organic by Quality Assurance International. They come in, they test all of your ingredients, and they test your products thoroughly. I only buy bulk herbs from QAI certified suppliers. They make sure there’s no residue of pesticide, no pharmaceutical medication, that it’s pure, and that everything’s been organically grown. Once they certify you, they slap their logo on your product and you can move forward. We’re also created in an FDA-certified facility right here in the United States. We’re not outsourced. That’s where a lot of that comes from.”

Wilson’s product caught the attention of a Columbia University teaching professor she met at an organic trade show. Dr. Aaron Katz, vice-chair of urology at Columbia, took an interest in Hot Rawks because it includes cayenne, which has been reported to attack prostate cancer cells. Katz has hosted Wilson on his weekly New York-area radio show and has offered the use of Columbia’s facilities for a clinical trial.

Wilson said that the organic certification of Hot Rawks gives her company an upper hand with meeting FDA guidelines.

“They know it’s a quality product,” Wilson said. “The word ‘natural’ is not regulated by the FDA. One of the reasons I got into this industry was I got sick of seeing companies falsely market their products and make people buy them because they say ‘natural’ on the front. I’m a label reader, so I read into the label, but a lot of people don’t. The more research I did, I found out that ‘Organic’ is regulated. You can’t put ‘Organic’ on the front of a package without it being regulated.

“People are unsure about the quality of stuff, and I’m passionate that our customers get the every best herbs. We don’t even use gelatin in our capsules. We use pullulan. It’s all-natural, with no animal products in it. We have to use it to be QAI certified. We can’t use just any veggie capsule.”


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