I’ve received several questions about the safety of cod liver oil (CLO) since the Vitamin D Council warned consumers about the ingestion of CLO due to concerns about potential vitamin A toxicity in their November bulletin.
Sally Fallon, president of the Weston A. Price Foundation, recently wrote a letter to members clarifying the issues raised by the Vitamin D council and exonerating cod liver oil.
If you’re having second thoughts about the health benefits of CLO, please read this and pass it on to anyone you know who currently takes or is considering taking cod liver oil.
————————–
Dear Members,
We are obliged to issue another official statement on cod liver oil after the November bulletin of the Vitamin D Council, which contains “an unprecedented warning about the ingestion of cod liver oil and resultant vitamin A toxicity.”
The warning accompanies a report on a review article co-authored by Dr. John Cannell, head of the Vitamin D Council, and fifteen other researchers, entitled “Cod Liver Oil, Vitamin A Toxicity, Frequent Respiratory Infections, and the Vitamin D Deficiency Epidemic” in the November issue of Annals of Otology, Rhinology and Laryngology.
NO PROOF THAT VITAMIN A IS TOXIC
Most of this paper is a review of studies showing the benefits of vitamin D in protecting against various illnesses, including respiratory infection. THIS PAPER DOES NOT PRESENT ANY INFORMATION WHATSOEVER INDICATING THAT COD LIVER OIL IS TOXIC, and, in fact, admits that vitamin A can significantly reduce the incidence of acute lower respiratory tract infections in Third World children.
A portion of the review article is an attempt to explain why a 2004 study providing 600 to 700 IU of vitamin D and 3,500 IU of vitamin A in the form of cod liver oil and a multivitamin failed to meaningfully reduce upper respiratory tract infections when studies from the 1930s found that cod liver oil could reduce the incidence of these infections by 30 to 50 percent. The authors of the recent commentary suggested that the older studies were more effective because cod liver oil in the 1930s contained much more vitamin D. They suggested that modern cod liver oil is low in vitamin D because the deodorization process removes the vitamin while manufacturers fortify the oil with only a fraction of the original amount. As an example, they cited cod liver oil made by Nordic Naturals, advertised as containing only “naturally occurring vitamins A and D,” which has only 3 to 60 IU of vitamin D per tablespoon but between 150 and 12,000 times as much vitamin A.
This conclusion is essentially the same as the conclusion reached by the Weston A. Price Foundation and the research of Chris Masterjohn; we have continually pointed out that vitamins A and D work together and that without vitamin D, vitamin A can be ineffective or even toxic. We do not recommend Nordic Naturals regular cod liver oil or any brand of cod liver oil that is low in vitamin D. But it is completely inappropriate to conclude from this 2004 study that cod liver oil is toxic because of its vitamin A content. Similar reviews could be put together showing the benefits of vitamin A and cod liver oil in numerous studies, including the studies from the 1930s. Obviously the solution is to use the type of cod liver oil that people took in the 1930s, which did not have most of the vitamin D removed by modern processing techniques.
I recommend Extra Virgin Cod Liver Oil from Rosita as my preferred cod liver oil product. It is real Norwegian cod liver oil that is fresh, raw & handcrafted from wild livers using a very rare ancient extraction technique which uses nature to separate the oil from its liver. No chemicals, solvents and mechanical devices are ever used during the extraction process, and it is free of heavy metals, dioxins, PCBs, and other contaminants (verified by independent testing on Rosita’s website).
VITAMIN A DOES NOT ANTAGONIZE VITAMIN D
The Vitamin D Council report claims that the vitamin A in cod liver oil is excessive and antagonizes vitamin D by inhibiting the binding of its active form to DNA and thus preventing its ability to regulate the expression of vitamin D-responsive genes.
Vitamins A and D are both precursors to active hormones that regulate the expression of genes. The body possesses certain enzymes that convert each of these in a two-step process to their active forms: vitamin A is converted to retinal and then to active retinoic acid while vitamin D is converted to calcidiol and then to active calcitriol. While directly consuming either retinoic acid or calcitriol would be unnatural, consuming vitamins A and D, together, as in cod liver oil, is perfectly natural. The enzymes involved in these conversions are responsible for producing incredibly powerful hormones and are therefore highly regulated.
In order for vitamin D to activate the expression of its target genes, it must bind to the vitamin D receptor (VDR) and then combine with the retinoid X receptor (RXR), which is activated by a particular form of vitamin A called 9-cis retinoic acid. RESEARCHERS FROM SPAIN RECENTLY SHOWED THAT VITAMIN D CAN ONLY EFFECTIVELY ACTIVATE TARGET GENES WHEN ITS PARTNER RECEPTOR IS ACTIVATED BY VITAMIN A.
In the ABSENCE OF VITAMIN A, molecules called “corepressors” bind to the VDR/RXR complex and PREVENT vitamin D from functioning.
The molecular biology of 9-cis¬ retinoic acid, however, is extremely complex, and this has led to some confusion. The RXR and its activator 9-cis retinoic acid partner up not only with the vitamin D receptor, but also with the receptors for steroid hormones, thyroid hormone, and most other nuclear receptors. In fact, if enough 9-cis retinoic acid is present, RXRs will even partner up with themselves. Ordinarily, this versatile form of vitamin A is gradually derived in small amounts from the larger pool of all-trans retinoic acid as needed. When scientists add large amounts of 9-cis retinoic acid to isolated cells, then, it may cause effects that smaller amounts naturally produced in the cell would not cause.
Researchers have shown, for example, that 9-cis retinoic acid interferes with the ability of vitamin D to stimulate the production of osteocalcin, a vitamin K-dependent protein involved in organizing the mineralized matrix of bone. This may have been because the excessive amount of 9-cis retinoic acid caused RXRs to pair up with themselves and thereby made these receptors unavailable to vitamin D. When scientists incubate cells with activated vitamin D and all-trans retinoic acid, ordinarily the source of 9¬-cis retinoic acid in the cell, the two hormones stimulate the production of osteocalcin with remarkable synergy.
More information on the interactions between vitamins A and D can be found in these articles:
Does Vitamin A Cause Osteoporosis?
The Spanish research demonstrating the necessity of 9-cis-retinoic acid for the functioning of the vitamin D receptor can be found here, and here:
Like what you’re reading? Get my free newsletter, recipes, eBooks, product recommendations, and more!
PLANT FOODS ARE NOT A GOOD SOURCE OF VITAMIN A
In the December Vitamin D Council newsletter, Dr. Cannell further claims that consuming preformed vitamin A is “unnatural” and that the body highly regulates the conversion of carotenoids found in vegetables to vitamin A as needed. However, the enzymes that convert carotenoids to vitamin A are less critically maintained because they are unneeded when preformed vitamin A is provided in the diet-as it usually is. They are therefore, like the enzymes that convert essential fatty acids in plant oils to their elongated and desaturated forms, subject to variations in genetics, circumstantial health, and dietary and environmental influences.
Many factors can interfere with the conversion of carotenoids into vitamin A including thyroid problems, liver problems, diabetes and genetics. Babies and children convert carotenes very poorly if at all.
The statement that preformed vitamin A is unnatural is ludicrous in the light of what we know about traditional diets. The chief source of calories in the traditional Inuit diet, for example, is seal oil, which Weston Price found to be higher in vitamin A than cod liver oil. Fish heads, extremely rich in vitamin A, are a staple in the Japanese diet. Many cultures consume liver, often in high amounts-yet the authors of the review paper imply that liver is toxic. Tell that to the Frenchman enjoying his foie gras, the Englishman consuming liver and onions, or the South Sea Islander who submits to great danger to obtain shark liver for men and women, in order to ensure healthy children. The truth is that pre-formed vitamin A is more plentiful in traditional foods than vitamin D, yet politically correct nutrition insists that we must obtain vitamin A through the laborious process of converting carotenes.
More information on the conversion of carotenoids to vitamin A can be found in this article and this one: (see the section “Vitamin A Vagary”).
COD LIVER OIL IN PREGNANCY
The Annals paper does not cite any studies showing toxic effects from cod liver oil, but Dr. Cannell cites one study in his December newsletter associating intake of cod liver oil with hypertensive disorders during pregnancy. Users of cod liver oil in this study had about twice the intake of vitamins A and D as non-users and eight times the intake of long-chain omega-3 fatty acids. The study found the most robust association with long-chain omega-3 fatty acids, which were associated with lower risk between 0.1 and 0.9 grams per day and higher risk above 0.9 grams per day. The authors suggested that the association with high blood pressure might be related to oxidative stress caused by a high intake of polyunsaturated fatty acids.
The abstract of the study can be found here:
The new Annals article offers nothing new to incriminate cod liver oil. It provides a well-written argument that vitamin D intakes need to be higher and incriminates only highly processed modern cod liver oils that have inadequate amounts of this critical nutrient. We recommend only high-vitamin cod liver oils that provide abundant vitamins A and D without an excess of polyunsaturated fatty acids.
THE COD LIVER OIL PUBLIC HEALTH INITIATIVE
As we pointed out in our last update on cod liver oil, during the first half of the century, cod liver oil was the focus of a worldwide health initiative. Parents were urged to give cod liver oil to their children by doctors, by government officials, by teachers and principals in schools, and even by their ministers in churches. A large portion of adults in America born before the Second World War received cod liver oil as children and this practice contributed to a high level of health, intelligence and physical development in those lucky enough to receive it. In many European countries, children received a daily ration of cod liver oil, especially during the war years. In the UK, for example, the government issued cod liver oil to all growing children until the early 1950s.
What has led to the demise of this obviously beneficial practice? Cod liver oil is a food; it can’t be patented, it can’t be created in a laboratory; it can’t create millions for the drug companies. So interest in this wonderful superfood has naturally waned. But if you are basing your dietary habits on the principles of healthy nutritional diets, don’t hesitate to include cod liver oil-our recommended brands of cod liver oil–as a healthy and natural food source of critical vitamins so lacking in modern diets.
Sally Fallon, President
The Weston A. Price Foundation
recommended links
- Dr. Ron’s: a great place to purchase Blue Ice High Vitamin and Fermented Cod Liver oil. I also like Dr. Ron’s line of additive-free supplements.
Better supplementation. Fewer supplements.
Close the nutrient gap to feel and perform your best.
A daily stack of supplements designed to meet your most critical needs.
From drrons website –
“A New Message from Dr. Ron: We will no longer carry Green Pasture Fermented Cod Liver Oil and Butter Oil.”
See article on that website – Hook, Line and Stinker: The Truth About Fermented Cod Liver Oil
Chris – Could you please take a look and see if the article makes sense enough to remove this product from your recommendation list?
Thanks
I’ve been a scam-buster for small businesses for enough years that I recognize multiple red flags in this whole controversy.
So far no credible explanations on too many things from GP, and WAPFs answer dodged the issues – it appears to have been written by a politician.
These are the things I found in my own research: http://fermentacap.com/index.php?option=com_content&view=article&id=41&Itemid=200
The lead article promoted CLO as a natural source of Vit D etc and states “Cod liver oil is a food; it can’t be patented, it can’t be created in a laboratory; ”
NO IT IS NOT A FOOD! It is a product that would take a lot of food to produce. It might not be synthesised but is nonetheless a processed product, and suffers loss in the process so that most CLO is standardised with synthetic D to maintain stated levels. The FCLO product gets around augmenting its D by not stating the levels it contains (!!) on the grounds that levels are constantly changing between batches (!!!)
The article is extremely outdated and I continue to wonder what purpose it serves. GP FCLO promotion seems likely…
My daughter has taken fermented CLO (Blue Ice) since about 9 months of age. She has never brushed her teeth (not that I’m proud of that) and doesn’t have a single cavity. Gorgeous white teeth.
I meant to mention that she is 4.
I did not expect my 0 to 4 year old children to brush their own teeth. In fact, after several seconds of playing at brushing, I took over and brushed their teeth nightly until they were well into elementary school and both willing and able to do it themselves. Their heads were in my lap as I brushed, without tooth paste, then I flossed. They are all adults now, with no cavities, except the one who took to eating raisin sandwich snacks in his teens and did not brush right after. He has one filling from that snack choice.
My 2 boys DID NOT have FCLO and only one has had a single filling after he was 30+ yo.
Does your daughter take the GP FCLO alone or with the High Vitamin Butter Oil? Thanks!
http://www.foodrenegade.com/take-instead-of-cod-liver-oil/
I mentioned some of my ideas previously. The above is a great take as well.
My 2 boys DID NOT have FCLO and only one has had a single filling after he was 30+ yo.
oops not meant for here!
The Vitacost vitD with cultured nutrients product does not state its source of vit D (?)
two red flags in this article:
1) the oil the author recommends is the oil they sell, presumably making a profit. recommendations are worth more if they come from someone who has nothing to gain from it. what are the good brands that the author *doesn’t* sell?
2) you cannot honestly equate how much fois gras a frenchman eats daily, or the shark liver a japanese family consumes, with a *daily, concentrated dose* of cod liver oil. to do so is misleading. also, depending on the toxins in the water, the liver may well be tainted, and concentrated liver oil poisonous – or radiation poisoned. (nuclear meltdown? runoff?)
how can we trust you if you are benefitting from us buying your “suggestion”?
lol and they’re the least of the problems with this supplement and recommended product source, which says a lot as those red flags are pretty bad!
Bottom line is cod liver oil is not a ” healthy and natural food source of critical vitamins ” because it is not natural at all. In this case it is a highly processed supplement of dubious quality. The benefits of using CLO is possibly being misrepresented but the FCLO is downright outrageous for its claims and for not being answerable to its detractors which have been many within this thread alone.
I’m not a medical expert but taking CLO has clearly improved my susceptibility to cold. I only recently got to know about CLO and it actually served as an antidote to colds for me
I have to agree. Since going through 3-4 bottles of fermented Cod Liver oil, my son and I have been cold free and no other illnesses thus far.
I strongly disagree. Taking cod liver oil has been almost miraculous in clearing up an arthritic big toe that had been giving me trouble for some time. The Vitamin D absorption maybe? – I think in the UK where a lack of good predictable sunshine has been almost ubiquitous for the last few years – even in the summer. I am convinced this is what is lacking in the average British diet.
The Blue Ice Cod Liver Oil’s website (a recommended product here) notes the absence of A/D content on the label is due to the variability of the nutrient assays due to “methodology, lab and batch”. This leaves me wondering how to know if the A/D ratio is balanced, which this article of course describes as important for vitamin D to stimulate the formation of osteocalcin?
Also, if some manufacturers need to fortify the oil with vitamin D, albeit insufficiently, due to depletion of D due to the processing procedure why shouldn’t I just take the pill form of vitamin D and skip the oil?
It seems that in taking the pill form of Vit D, you would be having a synthetic product which is tantamount to taking any other drug since it interferes with natural processes. Comparing the pill to taking an ‘augmented’ natural(?) product that is a fair question and to which I reply: that the difference maybe in degrees; that ‘natural’ is natural only if it is totally natural. ( despite what regulatory authorities allow to be called natural!) It is pretty clear reading through other comments below, that the GP FCLO product is way off being natural. I tried it and found it to be rancid in taste then investigated. I urge everyone to do that and not rely on misleading marketing information. 🙁
Re “I urge everyone to do that and not rely on misleading marketing information. 🙁 ”
To clarify: don’t waste money on trying this product on the basis of product promotion. Research it to discover whether the product performs as it states and also whether it surpasses fresh food and sunlight as Vit D3 sources.
Furthermore “absence of A/D content on the label ” says all you need to know and is code for “stay well clear of this product”….
On the topic of Rosita’s marine oils:
http://www.nutraingredients.com/Regulation-Policy/Norway-warns-on-polluted-fish-oil-supplements
Yep, I don’t trust them one bit. I am not sure why Dr Kresser is promoting them so much.
Optimal vitamin A / D ratio??
Sally Fallon says 10 A : 1 D, so as A not to be toxic
The “here” link to your recommended brands will not work for me. I am wondering about the purity and quality as well as the process in the making of Walmart’s, Spring Valley Norwegian Cod Liver Oil in the liquid form containing 900 mgs omega-3 fatty acids per tablespoon.
Thanks for catching that broken link Jamie. The brand Chris recommends can be found in his online store.
I don’t see the EPA and DHA content or the Vitamin A or D content on the label. Am I missing something or is that privileged info? I will not spend any money on a product the does not tell these important levels.
Did any of you readers buy the aforementioned Rosita cod liver oil? I would love to hear your opinions…still scared of the rancidity that may occur…thnx!
In my house we’ve always bought the Green Pastures brand, usually the Royal Butter Oil & FCLO. Never had a problem with it going rancid despite taking a fair few months to consume the whole jar.
It can’t “go rancid”, because it was already rancid when you purchased it.
I would read this article before buying Rosita’s products.
http://www.nutraingredients.com/Regulation-Policy/Norway-warns-on-polluted-fish-oil-supplements/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=02-Jul-2015&c=rtMFYiJ8sW5V80M74w7TAw%3D%3D&p2=
I just tried Rosita today for the first time and it is wonderful! I mixed it with sunflower lecithin and Winning Probiotics and feel high as my body and brain is being charged in a most wonderful way.
lol and they’re the least of the problems with this supplement and recommended product source, which says a lot as those red flags are pretty bad!
Bottom line is cod liver oil is not a ” healthy and natural food source of critical vitamins ” because it is not natural at all. In this case it is a highly processed supplement of dubious quality. The benefits of using CLO is possibly being misrepresented but the FCLO is downright outrageous for its claims and for not being answerable to its detractors which have been many within this thread alone.
You got a “body and brain” “charge” from 3 types of highly processed supplements – imagine what it would’ve been like from a natural meal.. Sometimes an unnatural high is due to drug like effects of concentrated molecules having been improperly processed as they are bypassing normal digestve mechanisms…
Actually Julielu,
85% of my foods are organic, many home grown. I work at home and make many meals from scratch.
Would you please elaborate on what you mean by “imagine what it would’ve been like from a natural meal”
What I am finding is that lubricating the gut with certain types of oils has immense power to heal brain fog issues. With a life time of allergy issues I have a lot of insight into this arena.
I rarely take supplements so adding Rosita Cod Liver Oil and organic lecithin is quite rare for me. From my perspective Rosita is an excellent product and has been proving itself to be an excellent supplement. I love the freshness of Rosita. It tastes very clean and fresh.
re “imagine what it would’ve been like from a natural meal”
My point was that natural nutrients tend to be unremarkable in their mind & body effect.
There is also no mention that the Vit D contained in the GP product is D2 & D3 (at least thats my advice in a personal email from another distributor). D2 research has indicated that it’s less effective and may not /does not perform the necessary functions of D3…
Previously this Q was raised by Tom @ Sep 9, 2014
“What type of D is in the fermented CLO?”
On the authority of product information disclosed in an email conversation I had with an Australian supplier of the GP FCLO products, I replied to Tom that the FCLO contained mostly vit D2 – see my previous response also at Sep 9 2014.
Vit D2 is Ergosterol; is produced by irradiating yeast or fungus; suitable for Vegetarian use and previously believed to be as effective as Vit D3 – Cholecalciferol which is of animal origin.
Recent research however, suggests that this is NOT the case and that therefore it cannot be assumed that the beneficial health results as seen in studies using Vit D3 should apply to Vit D2 also. Apparently it is the activity of the breakdown chemistry (that is different with Vit D2) that produces the effects shown in D3 studies.
So I would like to ask:
1. How did Ergosterol – Vit D2 form in the FCLO product from the natural animal food base?
Is this what GP are referring to as “fermented”
2. Does the Ergosterol form of Vit D provide the same effects that Weston Price wrote about?
Re:
“The warning accompanies a report on a review article co-authored by Dr. John Cannell, head of the Vitamin D Council, and fifteen other researchers, entitled “Cod Liver Oil, Vitamin A Toxicity, Frequent Respiratory Infections, and the Vitamin D Deficiency Epidemic” in the November issue of Annals of Otology, Rhinology and Laryngology.”
and the further response of Sally Fallon to that report referred to above .
There are no dates given for either of their comments, and they may well be VERY dated since they appeared, given that the lead article originated at the end of 2008.
This is interesting:
… the whole notion of fermenting cod liver oil is misguided. “You cannot ferment cod liver oil. Oil does not contain any sugars/starches, which are required for the friendly bacteria to grow.”
The Green Pasture practice of placing cod livers in a vat and letting them sit for six months doesn’t lead to fermentation, but rather to rotting …
http://thecompletepatient.com/article/2014/october/28/simmering-cod-liver-oil-imbroglio-heats-wapf-conference
The whole livers are fermented not just the oil. Livers contain sugar in the form of glycogen.
Perhaps, but during that time the oil is oxidizing and becoming rancid. The fact that fermented CLO has a peroxide value of zero just shows how rancid it is because peroxides are only formed during the early stages of oxidation and eventually degrade into anisidines and other oxidative byproducts. If you want a fresh oil, you actually want to see a small amount of peroxides (e.g. around 0.5 – 1) present because it shows that the oil hasn’t completely decomposed yet.
Gaston, thx for that article link. The thing is the argument is about much more than whose product is best.
How can anyone evaluate this without proper disclosure about the product: its processing and testing?
How can an influential organisation make a stand based on “trust me” when clearly there has been prolonged raging – and to date – unresolved differences about the FCLO product?
Personally I have no affiliation with any CLO manufacturer and only happened on this site from Google. However I am terribly concerned that a product can be marketed along the lines “let the buyer choose if its ok for them as an individual.” This is the 21 century and buyers should be expecting facts and making sure those facts are not misrepresented according to the laws as they apply.
It is my view, that can be seen expressed previously, that serious questions have not been answered by the author of the lead article , nor by the WAPF with respect to FCLO.
I would like to find more information about toxicity of mycellized vitamin A, which apparently bypasses the liver and therefore does not accumulate in the liver. To quote Dr. Atkins ‘Even in amounts of 100,000IU a day for months at a time, mycellized vitamin A has never caused any documented side effects.’ I’ve found a dose of up to 90,000IU regularly to be of benefit but am thinking I’ll start taking 5,000IU cod liver oil for maintenance and just use the mycellized A for occasional higher doses.
Everything you consume needs to be processed by the liver. Anything approaching 10,000 units per day could potentially burn up you liver, imo.
Did you just make that up?
Nope, that is biological fact. And I didn’t even write the comment.
gh see:
http://livertox.nih.gov/VitaminARetinoids.htm
Hepatotoxicity
Normal doses of vitamin A are not associated with liver injury or liver test abnormalities, but higher doses (generally more than 40,000 IU daily, ~12,000 μg) can be toxic. Acute toxicity is caused by a single or a few repeated very high doses (generally >100 times the RDA), arising within days to weeks with a typical symptom complex of severe headache, nausea, vertigo, blurred vision, muscle aches and lack of coordination, followed by skin desquamation and alopecia…… Chronic hypervitaminosis A usually arises 3 months to many years after starting moderately high levels of vitamin A (generally 10 times the RDA)……. bilirubin is typically only mildly elevated. Serum aminotransferase and alkaline phosphatase levels are variably increased, but usually only 1 to 4 times the upper limit of normal. Serum vitamin A levels are typically but not invariably elevated. Liver biopsy is diagnostic (generally over 1-8 years) ……before frank cirrhosis can be shown to be present. While high doses of vitamin A are usually achieved by vitamin A supplements, hypervitaminosis A can also occur with excessive dietary intake of liver, particularly that of carnivores (bears, seals, dogs) or salt-water fish (cod liver oil).”
see also the case studies given in the article.
Mycellized vitamin A is EVEN MORE toxic than regular vitamin A because it is absorbed better. If the vitamin A is absorbed, it’s going to be processed by your liver.
see Rheaume-Bleue: “The Calcium Paradox..” for a recent discussion about the necessity of consuming all the fat soluble Vits : A -Retinol, D3- Cholecalciferol, K2- Menaquinones and E- Tocopherols in balance to prevent toxicity of any in the absence of each other, at the time required by the bodies’ processes.
cont from previous..
and also note that it is these vitamins require the presence of fat to be absorbed / utilised.
Cont still..
I’ll also recall reading that Vit D (3) was beneficial in doses way above @ 10,000 per day, yet hardened arteries now seem to be correlated with combined supplemental D3 and calcium ( i.e. without K2 to direct the calcium properly into bone the D3 was contributing to the ossification of soft tissue especially seen in fine areas of the body. (The Calcium Paradox)
BEFORE EXPERIMENTING ON ONESELF – CHECK FOR SUPPORTING EVIDENCE FOR ALL HEALTH CLAIMS.
Here are some undeniable facts on Green Pastures’ Blue Ice Cod Liver Oil:
Fact #1:
-This product is misbranded under FDA labeling regulations for both foods (21 CFR 110) and dietary supplements (21 CFR 111). FDA labeling regulations for both foods and supplements require the disclosure of vitamin A content whenever the vitamin content exceeds 2% of the Daily Value (DV).
From 21 cfr 101.36(b)(2)(i) –
“The (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9(c).”
The failure to declare vitamin A content in excess of 100 IU per serving in either a food or dietary supplement is a violation of federal law. Blue Ice Cod Liver Oil is therefore illegally labeled (misbranded) and adulterated per FDA regulations. It does not matter that the vitamin A has not been added to the oil, it still must be declared. FDA does not care that every batch is different. Legally, therefore, each batch must therefore declare a different vitamin A content to me legal.
Fact #2: California Proposition 65 limits for PCBs are 0.090 PPM (90 PPB) for the total maximum daily serving. According to the test results listed on Green Pasture’s website, the PCB result obtained in 10/28/13 was 0.0381 PPM. This means that for this particular batch, consumption of more than 2.36 grams of this oil requires a Prop 65 warning in California for PCBs. Since doses in excess of 2.36 daily are quite commonly recommended, this product is in violation of Prop 65 regulations when sold in CA.
Any person consuming this product in CA can file a Prop 65 lawsuit against Green Pasture and win. It’s easy money for them to do so.
Fact #3: Foods and dietary supplements must contain directions for use on their labeling, and Blue Ice Cod Liver Oil does not. This too is a violation of FDA regulations, again making the product misbranded.
There are too many other violations committed by Green Pastures to list. I highly doubt they will survive their first FDA GMP inspection. Why anyone would trust consuming a product from a company that can’t even follow basic FDA regulations is beyond me.
Not correct…sad someone pretends to be factman
fda has viewed labels many times and these are legal documents with attorney and laboratories that specialize in the development of supplement and nutritional fact panels.
and also wrong on pcb and prop 65. prop 65 has nothing to do with serving size … too many errors worth direct discussion. my guess is person/post is a shill
This just proves that you truly don’t know what you’re doing, Dave. It may behoove you to know that FDA inspectors rarely delve into FDA labeling, as they don’t necessarily have all of the labeling specifics memorized. What they’ll do, if they suspect something is just not right, is take samples of labeled product back to the district office for review. Typically, a separate branch at the district level will then review the labels for accuracy. However, if the inspector doesn’t know to take a sample, it won’t make it to the district for further review. This does not mean that you’re labeling is correct. It just means you dodged a bullet.
Additionally, I posted the actual regulation that clearly states that you must label vitamin A content of your products. The limit is 2% of the DV. Kinda hard to argue with the actual reg Dave.
Finally, Prop 65 most definitely has everything to do with daily serving size. The PCB limit is 90 mcg PER DAY. At the one gram dosage or less the limit is therefore 90 PPB. At a two gram dosage, the limit becomes 45 PPB. At a 5 g dosage the limit is 18 PPB.
It’s right here in the GOED settlement agreement from the previous PCB lawsuit, Dave. You might want to review this lawsuit, considering these companies were sued for PCB levels similar to yours.
http://www.goedomega3.com/uploads/default/news_photos/prop_65_press_release-1.pdf
I’ll highlight the applicable portion below for clarity:
* To avoid triggering Prop 65 warning requirements in California, consumer products
also need to make sure that total exposure of PCBs from the
labeled dosage is less than
0.09mg (90n
Clarification on comment above. The limit is 0.090 mcg/g, which equates to 90 nanograms (ng) per day. Sorry for the conversion error.
Regardless, your product (at commonly used doses) will give consumers an excess of 90 ng of PCBs per day. The only way around this is to recommend a dosage that does not exceed a total sum of 90 ng of PCBs. For your product, this would have to be 2 grams daily.
Fact Man, not having done any research myself, I think you’re mistaken on a few points.
With regard to “Fact 1,” there a several exemptions from Nutritional Labels, such as the small business exemption and an exemption for selling products of nature (e.g., apples). I don’t know which exemption Green Pastures is falling under, but it seems obvious they do fall under an exemption given that one requirement for such exemptions is that the seller not make any claims regarding the nutritional content of their product. Green Pastures is annoyingly careful to avoid making any claims/statements along those lines.
With regard to “Fact #2” your claim doesn’t make sense. You state that Prop 65 limits PCBs to 90 PPB “for the total maximum daily serving.” You continue saying that given GP’s 38.1PPB, “consumption of more than 2.36 grams daily would require a Prop 65 warning.” In your later comment you state that the “PCB limit is .09 mcg/day.” That’s a very different statement than the 90 PPB. One is an absolute limit while the other is a ratable limit. I’ve never read Prop 65, but your comments conflict.
According to the GOED Prop 65 settlement you linked, the ratable limit is correct. The agreement there is to limit PCBs to “0.09mg/kg,” which is a ratable limit. There is no absolute limit per day or per serving. They would still be in compliance at 90,000 mcg/metric ton Per your post, GP’s product has 38.1 PPB, which is less than half the amount agreed to in the GOED settlement.
BTW, GP’s suggested serving is 2 grams, so even under your mistaken interpretation they would still avoid the need for a Prop 65 warning.
I’m guessing you don’t have any, but I would be interested to see any support you have for your claim of PBC daily maximums under Prop 65 that would apply here.
Website content is considered labeling by FDA and the CA Attorney General under Proposition 65. This link clearly shows that dosages in excess of 2 ml are meant to be consumed, in particular by pregnant women, with no mention of the required Prop 65 warning for PCBs and even vitamin A and birth defects.
http://www.greenpasture.org/public/FAQ/index.cfm#1
There is no exemption from FDA labeling requirements for vitamin A labeling no matter how small the company. The same applies to Prop 65.
You are correct that I have two different limits. The Prop 65 limit is 90 PPB for dosages up to and including 1 gram daily. Above 1 gram daily, the limit is decreased per gram and the 90 mcg/day limit applies.
I took GP FCLO along with my prenatal vitamins during my first and second trimester of pregnancy. Doctor didn’t mention this was unsafe, but during my third trimester I stopped taking it altogether because I started to read articles on Vitamin A and excess levels of Vitamin can lead to birth defects. I’m now scared that taking the FCLO has affected my unborn child. I’m in my third trimester now and am really worried. What do I do now? I’ve spoken to a “service rep” at GP (who was rude and unhelpful when asking about the levels of Vitamin A in each batch). I’m really worried about my unborn child since I’ve already went through two and a half bottles of the FCLO during my first and second trimester
How is everything with your Baby?? is he or she doing ok
Yeah, and the FDA is so trustworthy and most definitely looking out for the health and well-being of all of us.
Yes, and obtaining nutrition advice from a dentist because he studied indigenous people’s teeth is also a good idea.
Why are you disparaging Weston Price? You will convince very few with such attacks.
Whereas, the FDA is a captured regulator that essentially works for big pharma. Barking up the wrong tree on this site.
Because the Weston Price Foundation is recommending the consumption of a rancid and poor quality oil that is more likely to harm you than help you. This oil is also produced in violation of current good manufacturing practices and is labeled in violation of current labeling laws (i.e. it is illegally labeled).
Ive been taking that product for over a month now and I think its fantastic. Fat going away from problem areas, muscle growing.. after 1 week of taking it, i woke up happy.. and not that Ive ever been disagnosed with depression but I have no doubt this FCLO/HVBO product is the cure for people with depression.
Are you saying this in comparison to a non-fermented cod liver oil which you used, but didn’t see these benefits? Consumption of omega-3 fatty acids in non fermented form is know to improve moods. I don’t see your story as proof that fermented is better, but rather as proof that omega-3s are food for you.
The standard tests for Vitamin A only test for 2 of the isomers. From the founder of the company “The vitamin levels likely test lower because we are only testing for retinol and palmitate, not for all the other vitamin A isomers. Anticipating increasingly stringent controls on supplements, we have decided to label the fermented cod liver oil as a food—which it certainly is. Thus the label will contain a suggested dose and list vitamin A as a percentage of the RDA. There will be no mention of vitamin D on the label.”
If the FCLO is going to be re-marketed as a food supplement without a disclosure for vit D content what is the point of the fermented product ( that also tastes unhelpfully awful)?
Also would that mean that loyal adherents of the product for its Vit D content, apparently be then unwittingly overdosing on its unstated toxic content if continuing to use FCLO for Vit D supplementation? (Despite there being no such recommendations OR otherwise on the label)
I feel strongly that the WAPF should also review and clarify this proposed labelling change of the GP- FCLO product given the respect and following WAPF has in the health & well being community. The situation re the proposed re-labelling makes the FCLO product more unsatisfactory in the context of current WAPF recommendations i would think.
The problem is, it’s not labeled as a food. It is clearly labeled as a Dietary Supplement.
Re its current labelling? (I take that to mean that the concerns you’ve raised don’t go away just because there is ‘future’ re-labelling to take place, If not please discuss further.)
FactMan -I was responding @ Matt to the news of the proposed labelling changes, which looks to be a fuzzy position for the future FCLO product.
However, to me the product is putrid and no matter what the labels states, or doesn’t state, it should not be reliant on marketplace sales on the recommendation of a respected org. like the WAPF. At this point i have left others to ‘dis’ on the product, and to direct my focus at The WAPF which promotes it to my likeminded health seekers community.
I have no way of crediting your claims without further research, but accept that you have made them, that they are substantially concerning for the probable safety of a product that many will continue to consume despite future re-labelling offering no such nutritional nor warning advice.
In fact the way I became aware of the “nutritional benefit” of GP FCLO as it currently stands, from the recommendations of the WAPF. At some point that org. has to separate fact from fiction and re-position its own integrity re this product.
ps. Fact Man, I am incredibly concerned about your warnings. If consumers are not already turned off by their own gut reaction to the FCLO, then maybe drawing attention to fuzzy practices of the labelling game will lead them to a better appreciation of the likely health rip off claims being made on its behalf by the WAPF. I Thank -you.
The irony of it all is that the specific regulation that requires vitamin A content to be disclosed actually comes from the FOOD regulations (21 CFR 110), not the dietary supplement regulations (21 CFR 111). However, both foods and dietary supplements must follow the basic regulations for vitamin A labeling. They can change it from a supplement to a food, but they will still be in violation of the law of they don’t accurately disclose the vitamin A content.
LOL re Irony! My concern rests with the non-compliance angle and therefore lack of integrity extends to the product itself and to the WAPF which endorses it. Very disappointing.. apparently excess Vit A is held in check by Vit D (when its available) according to the author of “TheCalcium Paradox..” But that further illustrates the need for compliant correct labelling as most supplements are taken without prescription and likely lack of being in full facts.
I occasionally come back around to sites like this which promote similar themes about “whole” foods and offer hope that things like debilitating depression or might be just be fixable with some wholesome “natural” food or other. I guess I should know better.
In any case, thank you to julielu, Fact man, & Gaston Liberman for injecting some reality and logic back into this discussion. I love the *idea* of a paleo-esque diet/lifestyle; if we’ve forgotten or drifted away from resources that once helped us thrive I’m all for giving those a try. It would be the best of both worlds to borrow successful strategies from our past and combine with modern knowledge for optimal wellness, but so often, what ends up promoted and canonized in these communities amounts to magical thinking with little to no basis in reality. It makes me sad, but I needed the wake-up call.
–sadder but wiser
Can’t seriously believe the FDA cares about what we consume? They allow poisen in the food every day. If it’s FDA approved it’s poisen. Anyone who really cares about theur health today knows this fact.
I started taking green pastures fclo about 2 weeks ago. I started developing allergy like symptoms. Coughing, sneezing, runny nose and generally run down feeling. Have you ever heard of a reaction like this to fclo? It’s really driving me nuts! Thank you.
It’s common with the fclo. Read around.
It still bothers me to no end that weston price foundation headlines this as the best simply because it has a favorable a:d ratio. It is quite easy (and vastly more affordable) to supplement a quality CLO and simply take an additional vitD supp along with it. Weston price does not address this anywhere and I feel it is very misleading. After reading their articles it’s easy to get left with the feeling that green pastures fclo is the only safe or effective way to supp A and D. There are plenty of high quality liver oils with low vit d. So what? Add the vitD yourself and avoid the fclo.
Personally I eat liver, use desicated non defatted liver powder from NOW foods (grass fed cattle) and give my infant extra virgin CLO from rosita. A few drops of vitD takes care of any “imbalances” in the CLO just fine. Weston price foundation REALLY needs to update their information on how to more easily obtain A and D.
” It is quite easy (and vastly more affordable) to supplement a quality CLO and simply take an additional vitD supp along with it.”
Good point! I’ve yet to see a counter to this argument.
Here http://articles.mercola.com/sites/articles/archive/2008/12/23/important-cod-liver-oil-update.aspx
The problem with you adding your own Vitamin D is that Vitamin D pills arent real Vitamin D. Theyre just a sliver of Vitamin D… CLO will have all sorts of isomers of these vitamins.. therefore the resulting product is naturally replete.
@ Mike
re “will have all sorts of isomers of these vitamins.. therefore the resulting product is naturally replete.”
Assumptions and opinions such as: “will have” / “all sorts”/ “naturally replete”, are not facts, but that rancid oils can cause carcinogenic changes, is.
Delicate polyunsaturated oils are known to be easily damaged by oxygen and heat and therefore best consumed as part of their whole food source, in its fresh state.
Basking in Sunlight or consuming fresh raw / cooked liver is the naturally replete way to obtain Vit D, but since there is no claim for this FCLO product containing a balanced or complete spectrum of Vit D or even cofactors – it would seem there is no logic to challenge the usefulness of the ordinary Vit D (3 – currently acknowledged as the active form of D in humans) CLO supplement form.
reand not from consuming delicate polyunsaturated oil that has been subjected to dubious processed product.
Can anyone confirm that fermenting (rotting) codlivers is a process aimed not to augment Vit D content but to augment oil extraction without the usual processing technologies of non fermented CLO? If that is true
sorry forgot to edit out
“reand not from consuming delicate polyunsaturated oil that has been subjected to dubious processed product.”
Increasing Shelf Life and marketing it as safer is the #1 problem. Wheat, milk, salt, sugar, rice, vaccines are the major culprits
hi,
my daughter 9 yrs old, 26 kgs i s on GF/CF diet. since we are vegetarians i feel she is nutritionally deficient. pls suggest fermented codliver oil ok for her
regards
CLO is not a vegetarian supplement. I would recommend traditional diet for vegetarians, but if she is medically GF then the diagnosing doctor should be asked about her deficiency as she maybe eating too little , the wrong things or other food intolerances co-exist. I f she is medically sound then maybe she needs more calories to make up for lack of grains in her diet – increase full fat dairy products particularly butter / ghee for the Vit A and K2. Get her into the sun for Vit D ( if she has dark skin she needs greater time in it and maybe more often) Google for sources of vegetarian omega 3, but any benefit may be lost on the downsides of processed CLO and definitely don’t take risk using FCLO on a GF child. Note these are unqualified opinions only based on my own experience. It is far better to discuss this with your daughter’s doctor Please.
I’m not sure the best article to post this question. My husband is allergic to scallops; while he has not had a formal allergy panel done, he has had anaphylactic reactions both times to scallops, and accordingly, doesn’t consume shellfish. He eats all other types of fish without problem (salmon, tuna, anchovies etc).
It seems he should not “try” to see if he has a reaction to CLO, so
What would be good alternative(s) to the Blue Ice green pasture CLO you recommend?
I’ve read that a combination of Butter Oil/dessicated liver capsules for A, D, K2 would be good. But what about for omega-3s?
Research evidence favours Omega 3 from fish itself than from processed fish oil supplements. CLO is not generally standardised for Omega 3.
Cod liver oil can help to prevent serious diseases such as arthritis, diabetes, musculoskeletal pain, cancer, heart diseases, and so on. Share with you: http://www.healthdoyen.com/benefits-of-cod-liver-oil.html