Laugh, cause what's the point in crying. FDA: "Your walnuts are being promoted as drugs.

[TalkingDog]

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm

Based on claims made on your firm's website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":


• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."


• "mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "


• "n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."


Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act <21 U.S.C. § 321(g)(B)>. Your walnut products are also new drugs under section 201(p) of the Act <21 U.S.C. § 321(p)> because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act <21 U.S.C. § 355(a)>, they may not be legally marketed with the above claims in the United States without an approved new drug application. Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use <21 U.S.C. § 352(f)(1)>.

[provis99]

1. is nutmeg a Schedule 1 Drug?

After all, nutmeg technically can make you hallucinate.
http://en.wikipedia.org/wiki/Nutmeg#Psychoactivity_and_toxicity

[TalkingDog]

3. I think that's because nutmeg isn't advertising those effects.

I understand what the FDA is doing.... Technically they are doing their job.

But the US National Library of Medicine database contains over 35 peer-reviewed published papers supporting a claim that eating walnuts improves vascular health and may reduce heart attack risk.

And the topper (from Life Extension Magazine http://www.lef.org/magazine/mag2011/aug2011_FDA-Says-Walnuts-Are-Illegal-Drugs_01.htm )- FDA Allows Potato Chips to Be Advertised as “Heart Healthy”

Frito-Lay® is a subsidiary of the PepsiCo, Inc., makers of Pepsi-Cola. Frito-Lay® sells $12 billion a year of products that include:
Lays® Potato Chips
Doritos®
Tostitos®
Cheetos®
Fritos®
You might not associate these mostly-fried snack foods as being good for you, but the FDA has no problem allowing the Frito-Lay® website to state the following:

“Frito-Lay® snacks start with real farm-grown ingredients. You might be surprised at how much good stuff goes into your favorite snack. Good stuff like potatoes, which naturally contain vitamin C and essential minerals. Or corn, one of the world’s most popular grains, packed with thiamin, vitamin B6, and phosphorous—all necessary for healthy bones, teeth, nerves and muscles.

“And it’s not just the obvious ingredients. Our all-natural sunflower, corn and soybean oils contain good polyunsaturated and monounsaturated fats, which help lower total and LDL ‘bad’ cholesterol and maintain HDL ‘good’ cholesterol levels, which can support a healthy heart. Even salt, when eaten in moderation as part of a balanced diet, is essential for the body.”37
FDA Allows Potato Chips to Be Advertised as “Heart Healthy”

Wow! Based on what Frito-Lay® is allowed to state, it sounds like we should be living on these snacks. Who would want to ingest walnuts, pomegranate, or green tea (which the FDA is attacking) when these fat calorie-laden, mostly-fried carbohydrates are so widely available?

[jberryhill]

7. I think she stopped posting here

But unprocessed sassafras oil is.

[originalpckelly]

2. They can fuck with walnuts, but won't take on oscillococcinum?

This fraudulent "medicine" is being sold right next to actual medicines in drug stores and supermarkets.

It is nothing more than some table sugar and lactose.

Where is the letter for that?

[FLAprogressive]

8. +1000

[CleanGreenFuture]

4. This warning letter is 1 1/2 years old. Also,

there has been research done on walnuts and their health benefits:

http://www.walnuts.org/walnuts/index.cfm/health-professionals/walnuts-and-health/heart-health/

And...

http://www.ajcn.org/search?fulltext=walnuts+omega&submit=yes&x=0&y=0

So, I don't know what the FDA's problem is. I have contacted Diamond to get an update on this and am awaiting their response.

[TalkingDog]

5. The FDA's problem? $$$ and the political pressure that goes along with it.

But that's IMHO.

[CleanGreenFuture]

6. Well, I like walnuts in stuff like zuchini bread, fruit salad, etc. The FDA can suck it.

[unblock]

9. i have absolutely no problem with this.

i'm a big fan of government regulation when it comes to advertising and labeling.
i'm not an expert on the specific requirements, but there's a right way to taut the benefits of a food product and there are many wrong ways.

it should be easy enough to hire an expert, ask the fda, or just read the relevant regulations and wordsmith the claims so as to be acceptable and not fall foul of the regulations.

if you look at the labeling of many products, they usually don't say anything direct like "THIS product is healthy" or "this product helps with condition x". instead they just say "whatever MAY reduce cholesterol" or "whatever MAY help your bowels" and then say "ask your doctor for more information about the benefits of whatever". and then they say "this product is a good source of whatever".

so the only "claim" they're making about the product is that it CONTAINS whatever, which is easy to prove is true; then they supply some information about whatever, and refer you to an expert. this way there's no actual claim about medical benefits, that's left to the medical professionals and the consumers to determine.

[TalkingDog]

14. I will direct you to the Frito Lay info provided above.

And ask: How is this different?


“And it’s not just the obvious ingredients. Our all-natural sunflower, corn and soybean oils contain good polyunsaturated and monounsaturated fats, which help lower total and LDL ‘bad’ cholesterol and maintain HDL ‘good’ cholesterol levels, which can support a healthy heart. Even salt, when eaten in moderation as part of a balanced diet, is essential for the body.”37
FDA Allows Potato Chips to Be Advertised as “Heart Healthy”

[unblock]

15. i'm not an expert, but i'm sure the proper consultant help with what the fda approves

maybe it's there's a footnote, a disclaimer, or there are certain claims the fsa recognizes and others it doesn't.

i don't know, but i'm sure there's a way.

[sense]

10. Walnuts aren't near as profitable as

statins or anti-depressants. Can't have people eating well and avoiding the poisonous side affects of big pharma's synthetics. Greed is the worst poison of all.

[Chan790]

11. Ironically...many types of walnuts are toxic.

Eaten in large quantities, far larger than any human could ever actually eat, walnuts are a source of juglone, a highly-potent metabolic-inhibitor also used as a rapid-effect herbicide and insecticide. It's this same component that carries health benefits in humans and renders it unsuitable for pharmacological use...quantities large enough to have any medicinal benefit are too large to be sustainably used without causing organ damage.

In smaller quantities, it's used today as a colorant in foods and hair-dye where it produces a rich auburn brown.

[LLStarks]

12. The FDA has this warped mentality that only approved drugs can cure illness. nt

[freshwest]

13. Sounds like that CODEX crap.