Herbal Medicine, Fish Oil and Botanical Supplements- Caveat-Part IV

(1/29/20)- The results of a study done by researchers of 1,619 Danish men taking physical examinations for compulsory military service concluded that taking fish oil supplements during the previous 3 months may improve sperm quality. The results of the study were published in JAMA Network Open for which Dr. Tina Kold Jensen of the Copenhagen University Hospital was the lead author.

The researchers found no such effect among men who took supplements other than fish oil.

(12/16/19)- The U. S. Food and Drug Administration expanded the approved use of Amarin PLC’s fish oil drug Vascepa  to reduce the likelihood of heart attacks and strokes in high risk patients. The drug had been first approved in 2013 to help reduce the likelihood of heart attacks and strokes in patients with high triglyceride levels.

For further details on the drug, please see our item dated 11/16/19) below.

(11/24/19)- A review of an analysis, in the British Journal of Psychiatry, that included a broad range of long-term trials of omega-3 fatty acid supplementation found the supplements are not effective in treating or preventing depression and anxiety.

Neither length of treatment nor size of dosage demonstrated effectiveness.

The review included 32 randomized trials testing supplements of omega-3, linoleic acid and polyunsaturated fatty acids with 41,467 participants.

Lee Hooper of the University of East Anglia said that while the supplements did no good, they did not do any harm

(11/16/19)- An advisory panel recommended that the U.S. Food and Drug Administration (FDA) approve expanding the use of Amarin PLC”s fish-oil-derived drug Vascepa to help reduce the likelihood of heart attacks and strokes in high risk patients.

The panel voted 16-0 to enlarge the approved use of the drug, which the FDA had rejected when Amarin’s first requested approval for a broader label in 2013. Please also note that the agency rejected the fish oil claim in our item dated 4/6/15 below. That rejection prompted Amarin to sponsor the study that the panel voted in favor.

Last year sales of the drug total$230 million. Vascepa was first approved in 2012 for adults with high triglyceride levels,

The study showed that the drug could reduce the risk of cardiovascular disease events in patients with high triglyceride levels who are at high risk, and are on cholesterol lowering drugs.

Most patients in the study had already had a heart attack, stroke or other cardiovascular events. The other patients had Type 2 diabetes and at least one other risk factor, such as smoking.

The FDA is expected to act on the panel’s approval by December 28.

(10/25/18)-A new study, published online in JAMA this week found experimental stimulants in dietary supplementseven before and after the U.S. Food & Drug Administration (FDA) issued public warnings about the stimulants.

Peter Cohen, an associate professor at the Harvard Medical School and general internist at Cambridge Alliance, along with researhers from the University of California, San Francisco was the  lead author of the study. He stated: ”They do things we are concerned could lead to serioous health effects like heart attacks.”

 (4/26/15)- Back on 9/25/10 we wrote: “The federal government will be stepping up research into the safety and effectiveness of a wide range of over-the-counter dietary supplements, including plant oils, garlic, soy, elderberry, cicorice, black cohosh, St. John's wort and the Asian herb dong quai.

Sales of botanical supplements in the U.S. topped $5 billion last year, up 17% from 5 years earlier according to the non-profit American Botanical Council.

The Food and Drug Administration (FDA) has sent letters to the makers of eight dietary supplements warning them that some of their products contain a synthetic amphetamine like stimulant that medical experts say is dangerous.  The plant in question is known as acacia rigidula after it was reported that it contained an amphetamine-like stimulant called BMPEA.

Canadian health authorities pulled the supplement from stores in December, and warned that the chemical could cause strokes and other cardiovascular complications. The Food and Drug Administration discovered in 2013 that at least 9 products contained the stimulant but never warned the consumers, nor named the products involved.

For more information on this matter please see our article entitled: Herbal Products: Use with Caution

The results of a study published in the journal Drug Testing and Analysis named 11 supplements that tested positive for BMPEA, all of which listed acacia rigidula on their labels. VitaCost, a vitamin retailer owned by Kroger, the country’s largest supermarket chain, announced it was suspending sales of several of the named supplements.

The FDA said that its review of supplements containing the stimulant “does not identify a specific safety concern at this time.” The FDA discovered the chemical in product in 2013.

In the letter to 5 of the companies it advised them that BMPEA was neither an appropriate dietary ingredient nor an extract of acacia rigidula.

(4/6/15)- The vast majority of clinical trials involving fish oil have found no evidence that it lowers the risk of heart attack and stroke. In spite of this fact, it is the 3rd most widely used dietary supplement in the U.S. according to a recent report from the National Institute of Health. The majority of the clinical trials that were conducted between 2005 to 2012 involved patients who were at high risk of having a heart attack or stroke.

Some health experts say that the case for fish oil is still an open question. Dr. JoAnn Manson, the chief of preventive medicine at Brigham and Women’s Hospital in Boston is leading a five-year clinical trial, called the Vital study, of 26,000 people, who are representative of the population as a whole (not only high-risk heart attack and stroke patients).

(4/4/15)- As a follow-up to our item dated 2/14/15 below, GNC, the country’s largest dietary supplement retailer, has agreed to institute stricter testing procedures that exceed quality controls required under federal law. It was one of the 4 retailers of herbal supplements cited by N.Y. State Attorney-General Eric Schneiderman, who accused them of selling products that were fraudulent or contaminated with unlisted ingredients that could pose health risks to consumers.


GNC, which has more than 6,500 retail stores nationwide, said it would use advanced DNA testing to authenticate all of the plants that are used in the store brand herbal supplements, and extensively test the products for common allergens. It will also submit semiannual reports proving that it is complying with the attorney general’s demands.


Under a 1994 federal law, all supplements must carry on their labels the names and amount of every ingredient they contain.


(2/4/15)- New York State attorney general’s office has sent 4 large herbal supplement retailers cease-and-desist letters demanding that they explain what procedures they use to verify the ingredients in the supplements they are selling. The attorney general, Eric T. Schneiderman’s investigation was prompted by an article in the New York Times in 2013 that cited mislabeling and fraud by some supplement manufacturers.


The four retailers are GNC, Target, Walgreens and Walmart .Investigators found that their tests showed that four out of five products did not contain any of the herbs on their labels. The tested products were store brands. But the F.D.A. specifically requires companies to verify that every supplement they manufacture is safe and accurately labeled.


Under a 1994 federal law, supplements are exempt from the strict approval process required for prescription drugs.

 (9/25/10)- The federal government will be stepping up research into the safety and effectiveness of a wide range of over-the-counter dietary supplements, including plant oils, garlic, soy, elderberry, cicorice, black cohosh, St. John's wort and the Asian herb dong quai.

Sales of botanical supplements in the U.S. topped $5 billion last year, up 17% from 5 years earlier according to the non-profit American Botanical Council.

The federal Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, both units of the National Institutes of Health will be in the forefront of the effort. The agencies granted a total of $37 million to five dietary supplement research centers, expanding a program that has already awarded more than $250 million in research grants of herbs and botanicals since 2002.

The NIH is also funding research into botanical products through the National Cancer Institute, which is interested in how components in botanicals might influence cancer risk and tumor growth.

The FDA began requiring all supplement makers to follow strict quality manufacturing standards in June, but the agency only periodically inspects factories. Consumers can find out about potential uses, benefits and risks of dietary supplements at federal websites and Another government site, grades scientific evidence on a variety of supplements.

(2/14/10)- The results of a study that appeared in a recent edition of The Journal of the American College of Cardiology warn that popular herbs and supplements do not mix well with common heart drugs. They can also be dangerous for patients taking statins, blood thinners and blood pressure medications.

Dr. Arshad Jahangir, senior author of the paper added that popular supplements such as St. John's wort and even garlic and ginger do not mix well with many medications.

St. John's wort raises blood pressure and heart rate, and garlic and ginger increase the risk of bleeding in patients on blood thinners. Even grapefruit juice can be risky, increasing the effects of calcium-channel blockers and statins.

Soy milk, licorice, aloe vera and green tea were listed as products that can decrease the effectiveness of warfarin. Garlic supplements could potentially increase the risk of bleeding.

(8/10/09)-Americans spend almost a third as much money out-of pocket on herbal supplements and other alternative medicines as they do on prescription drugs, a new government report shows.

The estimate was based on responses to a national health survey conducted in 2007 by the CDC's National Center for Health Statistics (NCHS). National Center for Complementary and Alternative Medicine (NCCAM) Director Josephine P. Briggs, MD, said in a media briefing : "We estimate that this (represents) approximately 11% of the total out-of-pocket spending on health care."

(11/14/02)- Governor George E. Pataki, the Republican governor of New York signed into law a ban on the over-the-counter sales of ephedra in the state. The law includes a fine of up to $500 for each sale of the supplement. Ephedra can still be legally sold in the state if a doctor prescribes it. The Ephedra Education Council, an industry-financed group continues to claim that the supplement is safe when used correctly.

Tommy G. Thompson, Secretary of Health and Human Services, has delayed action in declaring whether or not ephedra, the popular weight-loss supplement is dangerous or not. He said the RAND Corporation, a research organization, would finish a "comprehensive review" of the studies that have been done on the supplement. The Rand report would be the basis for further study of ephedra, which is also known as ma huang, by the National Institutes of Health.

Ephedra supposedly increases metabolism and can raise the heart rate. Secretary Thompson stated "It is crucial that we have a full understanding of these dietary supplements" before we act on this matter. Health Canada, which is the Canadian equivalent of our FDA has expressed concern about excessive doses of ephedra.

We had previously written that the November 7, 2000 issue of the New England Journal of Medicine reported on a study of the risks of ephedra. Ephedra is an ingredient that is in natural appetite suppressants. As a natural appetite suppressant it is therefore classified as a dietary supplement, and therefore escapes regulation by the FDA. The article reported on the fact that 140 patients suffered serious side effects, including stroke and seizures, after taking ephedra products. Ten died and 13 % were permanently disabled.

The National Football League recently announced that it had placed the dietary supplement ephedra on its list of banned substances which would result in league action against any player who tested positive for its usage. A consumer advocacy group, the Public Citizens Health Research Group in Washington, and a prominent pharmacologist Dr. Raymond Woosley, vice-president of health sciences at the University of Arizona, have filed a petition with the FDA urging the agency to warn consumers not to use products that contain ephedra.

Ephedra has been linked to deaths, strokes, heart attacks and other health problems. It is also used under the Chinese name of ma huang. Ephedra is like amphetamines in that it stimulates the central nervous system, and is used in many weight loss and increased energy products.

The petition cited data from the American Association of Poison Control Centers, that showed that adverse events linked to ephedra in dietary supplements rose to 407 in 1999 from 258 in 1998, and 211 in 1997. In figures compiled by the FDA the total number of deaths and injuries caused by ephedra from January 1993 to February 2001 was 1,398. Those who defend the supplement claim that it is excessive usage that has caused the problem and feel that products using ephedra merely should state that fact on the label.

The heart of the problem can be traced back to the federal law of 1994 that essentially deregulated the dietary supplements. The law allows companies to make and sell dietary supplements without the same proof of safety and efficacy as is required of drugs. The safety of ephedra was attacked in 1997, but the FDA required only the mandatory warning label and a ban on ephedra's usage in combination with other stimulants.

We have written a number of articles about research on herbal medicine and various botanical supplements. While we take no stand on these alternative or complementary approaches to dealing with disease, we feel obligated to our readers to list the following caveats about the current "popular natural products" sold in over-the-counter settings. This does not imply that they do not work or are not effective as a treatment modality. It is only our attempt to provide a broad range of information to help readers make educated decisions about there approach to any kind of treatment.

A federal court in Utah has ruled that a dietary supplement made by Pharmanex Inc. needs FDA approval to sell its red yeast rice product, because legally it is a drug, not a dietary supplement. Dietary supplements do not need FDA approval in order to be sold.

Red yeast products contain lovastatin, the active ingredient in Merck & Co's cholesterol-lowering drug Mevacor. The FDA stated in a warning letter to the company that "due to potential side effects, drugs containing lovastatin may not be marketed over the counter."

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) announced the availability of the first issue of the "Annual Bibliography of Significant Advances in Dietary Supplement Research". Developed as a joint effort of ODS and the Consumer Healthcare Products Association (CHPA), this publication illustrates how the dietary supplement field is advancing through quality research. Copies of the first "Annual Bibliography of Significant Advances in Dietary Supplement Research" may be downloaded from the ODS website at

Single copies may also be requested by contacting the ODS office (301-435-2920 or

The following provides a list of shortcomings of the use of natural botanical products:

The following abstract is from an article by Simon R. J. Maxwell entitled "Antioxidant Vitamin Supplements: Update of their potential benefits and possible risks." that appeared in Drug Safety 1999; 21(4): 253-266 and would seem appropriate to the above statements.

Oxidate damage to biological structures has been implicated in the pathophysiology of cardiovascular disease and cancer, the 2 most common causes of death in developed countries. This has stimulated interest in the possible role of natural antioxidant vitamins in preventing the development of these diseases. Epidemiological studies have offered support for the notion that high blood concentrations or dietary intake of antioxidants may have a protective effect. On the basis of these findings and powerful marketing strategies, many healthy members of the population are now voluntarily consuming antioxidant supplements. A number of long term, prospective, randomized, placebo-controlled trials examining the protective effect of antioxidant supplements have been completed. The results have been generally disappointing and have provided little evidence of efficacy. Of greater concern, they have unexpectedly raised concerns that antioxidants, notably betacarotine might increase the rate of development of cancer in high-risk individuals. For this reason consumption of antioxidant vitamin supplements cannot yet be advocated as a healthy lifestyle trait.

Another researcher, E. Ernest states "Until more definitive evidence becomes available, we should employ CM (Complementary Medicine) where it seems to benefit the patient, and remaining cautious whenever there is the possibility of doing harm."

Increased research efforts, improved government regulations and long term monitoring of adverse reactions of natural treatment modalities may provide a clearer picture of the value of botanical and complementary medicine, leading to a reduction in devastating diseases. In the meantime, we suggest that people proceed with caution, but do not underestimate a potentially powerful method of treatment.

Caution: Always let your physician know all medications, including botanical medications and supplements or vitamins so that both of you may develop a treatment plan that is optimal for your situation. You want to eliminate any potential toxic drug-herb interaction.


Ernst E. Complementary medicine: does it have a role in the medical care of elderly people? Reviews in Clinical Gerontology 1999; 7:353-358

Linde K, Ramirez G, Muirow CD et al. St. John’s wort for depression: an overview and metaanalysis of randomized clinical trials. BMJ 1996; 318: 253-258.

Maxwell Simon RJ. Antioxidant Vitamin Supplements: Update of their Potential Benefits and Possible Risks. Drug Safety 1999; 21(4): 253-266.

Note: This author has been taking vitamins E, C and a one-a-day vitamin for the last 25 years and has added selenium and a daily aspirin to this regimen.

Please See: Herbs and Dietary Supplements-St. John's Wort-Part I
St. John’s Wort -Herbs and Dietary Supplements-Part II-Ephedra
Phytomedicine or Herbalist-What is It?-Part III
Treating Osteoarthritis with Dietary Supplements-Part V
St John's Wort: Does It Help Treat Depression-Part VI
Herbal Products: Use With Caution-Part VII
Kava: Safety Alert-Part VIII
Herbal Usage for Hormone Replacement Therapy-Part IX
Latest Research Questions the Effectiveness of Herbal Supplements-Part X


Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated January 29, 2020

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