FDA Allows Enhanced Claims for Vitamins and Herbal Remedies

(2/13/19)- The Food and Drug Administration (FDA) sent 12 warning letters and five online advisory letters to 17 nutritional supplement makers selling more than 58 products with improper claims that state the product can prevent, treat or cure serious medical diseases.

The companies have 15 business days to explain how the violations will be corrected, or they could face further enforcement actions.

U, S. supplement sales reached nearly $133 billion in 2016, according to the most recent data from Zion Market Research.

The FDA doesn’t review whether a supplement works and is safe, so that the manufacturers of these products are responsible for their safety. Over the past 5 years the agency has sent more than 4 warning letters to companies it determined had illegally marketed more than 80 products with false or misleading claims

(10/19/18)- The results of an analysis of data from 81 randomized controlled trials involving more than 53, 00 patients, determined that Vitamin D supplements do not help prevent fractures, increase bone mineral density or prevent falls in seniors. The report appears in the latest issue in the Lancet Diabetes & Endocrinology issue.

It was also determined that dosages made no differences. The lead author Dr. Mark J,Bolland, an associate professor at the  University of Auckland, said that aside from people with severe vitamin deficiency, the usage of the supplement showed no substantial benefit for those taking the suuplement.

(4/20/18)- The U.S. Preventive Services Task Force is no longer recommending that older adults take vitamin D to help prevent falls. The task force says that exercise and physical therapy are good prevention tactics for adults age 65 and older who live at home and are at risk of falling. But the task force axed its 2012 recommendation to also take vitamin D.

(11/24/14)- Taking vitamin B12 and folic acid supplements may not reduce the risk of memory and thinking problems after all, according to a new study. The study is one of the largest to date to test long-term use of supplements and thinking and memory skills. (Source: American Academy of Neurology (AAN). "Vitamin B may not reduce risk of memory loss after all." Science Daily, 12 November 2014. <>.)

(3/11/09)- Mannatech Inc.will pay a total of $6 million, and its founder will pay $1 million to settle the Texas attorney general's allegation that the company made false claims about the health benefits of its vitamins and supplements.

Texas Attorney General Greg Abbott filed suit in 2007 accusing the Coppell, Texas company of exaggerating the therapeutic benefits of its nutritional products. Marketing material falsely claimed that Mannatech's supplements, especially its best selling product Ambrotose, could cure or treat Down syndrome, cystic fibrosis, cancer and other serious diseases.

The company agreed to pay $4 million in restitution to people who bought the products and $2 million to pay for the state's investigation. Sam Caster, the company's founder, former chairman and biggest shareholder, will pay a $1 million civil penalty and is barred from serving as an officer, director or employee of the company for five years.

(10/5/05)- The FDA is reconsidering limiting health claims on food labels that aren't completely proven after a government study found that such claims confuse the consumer. The study was based on 1,920 adult volunteers from 5 shopping centers throughout the U.S. Along with some outside research, it will be reviewed at an FDA public hearing November 17, followed by a 45-day commenting period.

"Qualified health claims" that appear on food labels often confuse the consumer. These claims that appear on food labels must be accompanied by a disclaimer or other language to indicate the level of supporting evidence were found to confuse rather than help educate the consumer. The claims drew a rosier picture of the underlying evidence when a ranking order was displayed. Even when the claims were understood as intended, they had unexpected effects on the consumer's judgment about the health benefits.

Until two years ago, only claims based on science were allowed on food labels. The FDA started to allow companies to make "qualified claims" following court rulings that the agency could not block the companies from putting true statements on labels. Health claims characterize the relationship between food, or a nutrient, and a disease or health condition.

(8/1/03)-Watermelon growers, shippers and importers are spreading the word that their product is a better source of lycopene than is tomatoes , a substance that preliminary research has linked to helping to lower the risk of cancer and heart disease. So far there is no definite proof that lycopene does lower the risk of either of these maladies but the FDA is allowing the ads in the media.

The U.S. Highbush Blueberry Council is running ads touting blueberries as No.1 "in antioxidant activity." Antioxidants are compounds thought to fight free radicals, which damage cells and cause age-related diseases. The California Dried Plum Board makes the same claim for prunes. People involved in the sale of raisins make the same claim for their fruit. So far there is no proof that antioxidants prevents disease.

The Cherry Marketing Institute claims that their fruit has certain compounds called flavanoids that block pain in the same way as does arthritis medications do. The Cranberry Marketing Committee claims that their product plays a significant role in reducing the risk of heart disease, cancer, gum disease and ulcers. None of the above claims have been proven so far.

Nutrition experts recommend at least five servings a day of fruits and vegetables, which unfortunately most of us don't do. In general, frozen fruit is just as nutritious as fresh, and canned fruits are excellent also as long as they are not packed in syrup.

Some recent research studies indicate that one type of vitamin E (the gamma-tocopherol type) may help prevent prostate cancer and heart disease. Emphasis is on the gamma-tocopherol type rather than the more common alpha-tocopherol type of vitamin E. Incidentally vitamin E is the second best selling vitamin in the U.S., with multi-vitamins being the top seller. Sales of vitamin E topped the $810 million mark last year.

A number of physicians now recommend the intake of the gamma-tocopherol type of vitamin E in addition to eating foods that are rich in the vitamin. There is little evidence to support the claim that vitamin E enhances your sexual prowess.

Vitamin E supplements containing gamma-tocopherol usually are found in health food or specialty vitamin stores. They usually come in bottles labeled as containing "assorted" or "mixed" tocopherols. General Nutrition Corp. (GNC stores) of Pittsburgh makes and sells the mixed form with gamma-tocopherol. Foods that contain vitamin E, particularly with the type with gamma-tocopherol include egg yolk, almonds, and canola, olive and soybean oils.

A recent change in FDA policy may blur the differences between disease claims and structure/function claims. Disease claims involve claims about treatment, prevention or cure of a particular disease. Structural/functional claims involve the healthful "structure" or "function" of the body.

The FDA announced that they would allow greater latitude in the health claims that manufacturers of vitamins, herbal remedies and other dietary supplements will be allowed to make. Up to now manufacturers couldn’t make disease claims. This was the result of the 1998 ruling by FDA that defined disease so that supplement manufacturers could not make disease claims without prior approval from the FDA.

Medications i.e. prescription drugs that make disease claims must go through rigorous clinical trials before they are approved for use. (For informational purposes, it should be noted that in regards to prescription drugs, the FDA allows products to contain slightly less (10 percent below) or slightly more (10 percent) than the contents state on the label.)

What the new ruling does is to suggest those normal life stages such as aging are not diseases and therefore the manufacturer can make structural/functional claims for their products. The FDA stated " These changes, which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of ‘disease’ in response to comments that it was too broad and permitting structure/function claims about certain common conditions associated with aging, menopause, pregnancy and adolescence. Serious conditions associated with aging, pregnancy, menopause and adolescence, such as toxemia of pregnancy and osteoporosis, will continue to be treated as diseases".

Groups like Public Interest suggest that this change allows supplement manufacturers to make claims without pre-market approval by the FDA. Consumers should also be aware that different manufacturers of the same product might put different levels of the active herb ingredient or other supplements into the product. The Boston Globe featured in its January 10, 2000 Health/Science page an article entitled "St. John’s Wort: Less than Meets the Eye." They had two independent laboratories analyze the active ingredient of seven St. John’s wort products plus a placebo. All products were placed into bottles coded by numbers.

They found "that there was considerable chemical and biological variation among the products tested." Only one product lived up to the claims on the product label. The standard that the FDA uses is that these products contain at least 100% of what is declared on the label. They not specify what tests should be used, nor do they require that the products be approved for safety or efficacy before they are marketed.

The American Botanical Council in its comments on the Boston Globe study indicated that "one of the results of this Globe study will be to hasten the adoption by industry organizations of uniform methods of labeling standardized products-an issue that the industry has been working on for some time." Let us all hope that they get their act together and establish uniform standards that insure quality control.

We will continue to monitor this issue and report to our readers any study in the area of supplements, herbal remedies and vitamins. We would recommend that you always consult your treating physician before making the decision to use supplements.


By Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated February 13, 2019

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