Should the FDA Regulate Vitamins, Herbs, and Other Supplements?
Should the FDA Regulate Vitamins, Herbs, and Other Supplements?
Written by Cameron Scott | Published July 25, 2015
People in the United States will spend more than $20 billion on vitamins and herbal supplements in 2015, by some counts. Generally, regulators see the products as foods that people can choose to buy, as long as their manufacturers don’t misrepresent what they are and as long as they don’t contain unsafe contaminants. Unlike pharmaceuticals, the government does not require supplement makers to prove their products are safe before they can sell it.
But in recent months some supplements tested by the New York State Attorney General’s office were found to contain none of the main ingredients listed on their labels. The Food and Drug Administration (FDA) also warned the public about multiple weight loss and energy supplements that contained a dangerous chemical called BMPEA, which is similar to amphetamines.
Industry representatives say bad products can be controlled with enforcement of the existing rules. But Congress is calling on the FDA to investigate the industry more broadly and to potentially introduce stricter rules.
Healthline asked several experts whether they thought more regulation is needed. Here’s what they said.
“Some products may not contain what the label claims…”Dr. Robert WerginPresident of the American Academy of Family Physicians
“Our industry has a strong safety profile…”Steve MisterPresident and CEO, Council for Responsible Nutrition- “Dietary supplements have their place in promoting health…”Kasra Pournadeali, N.D.President, American Association of Naturopathic Physicians
- “(The standards) invite misconduct and fraud and fails to adequately assure consumers…”Marty MackExecutive deputy attorney general for regional offices of the New York State Attorney General’s office
- “The current regulatory regime is largely only reactive to problems…”Ryan O’MalleySpokesman, Academy of Nutrition and Dietetics
- “The claims touted on the supplement labels are inaccurate at best…”Denine Stracker, M.P.H.R.D.N., lecturer and blogger at Apples and Olives
- “Consumers believe that over-the-counter supplements are regulated…”Felicia D. Stoler, D.C.N., M.S., R.D.N., F.A.C.S.M.,Nutritionist and exercise physiologist, author of “Living Skinny in Fat Genes: The Healthy Way to Lose Weight and Feel Great
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Vitamin and herbal dietary supplements constitute a booming business, and with that business comes responsibility. Supplements should contain exactly what they purport to contain.
Currently, some products may not contain what the label claims. Consumers can protect against this issue by purchasing products that have the USP verified dietary supplement mark on the packaging.
The mainstream dietary supplement industry encourages fuller implementation and enforcement by the FDA and the Federal Trade Commission of the current laws, which cover all facets of dietary supplement manufacturing, labeling, marketing, and post-market surveillance.
Our industry has a strong safety profile, and the law provides an appropriate regulatory framework that allows for consumer access to a wide variety of affordable, high quality, safe, and beneficial dietary supplement products. The government agencies have the tools and we’d like to see them use those tools.
Dietary supplements have their place in promoting health. In recommending dietary supplements to patients, naturopathic physicians depend on high-quality products. This means the products must meet FDA current good manufacturing practices, such as the label claim for active ingredients. The majority of companies, especially those providing supplements directly to naturopathic physicians, produce a consistently high-quality product.
Especially given the recent issues in New York state (where the attorney general used an inappropriate method of testing finished products), we support the FDA addressing this on a national level in order to protect consumer safety using its existing authority under the Dietary Supplement Health and Education Act.
When consumers take a dietary supplement, they should be able to do so with full knowledge of what is in that product, and confidence that every precaution was taken to ensure its authenticity and purity.
While the FDA exerts limited oversight over dietary supplements, those standards and their enforcement are much less rigorous than those for pharmaceutical products or even food additives. This invites misconduct and fraud and fails to adequately assure consumers that products are free of dangerous levels of contaminants.
To fully address the authenticity and purity issues plaguing the dietary supplements industry nationwide, however, it will take major regulatory changes at the federal level.
The Academy of Nutrition and Dietetics enthusiastically supports the National Institutes of Health’s Office of Dietary Supplements’ research on supplements and their efforts, along with the FDA, to ensure the safety of dietary supplements sold in the United States.
Americans spend billions of dollars on dietary supplements despite ongoing concerns regarding their safety and effectiveness. The current regulatory regime is largely only reactive to problems with supplements sold, but the Academy believes Americans who purchase dietary supplements to address a nutritional deficiency or for other purposes should be able to have confidence in the safety, quality, and verifiability of the supplements they consume.
The FDA currently lacks the power to effectively prevent fraud and abuse within the supplement industry. This has been a longstanding problem as well as a public health concern.
While the FDA can challenge supplement safety and labeling, this is typically done retroactively, after the product has been on the market. Supplements are sold to the public without prior safety reviews, and the argument that self-regulation is effective no longer holds a strong position. This is a fundamental flaw of the current regulation.
Since the Dietary Supplement Health and Education Act was passed in 1994, the supplement industry has gained immense power. The claims touted on the supplement labels are inaccurate at best and misleading at worst, leaving the consumer overwhelmed, misinformed, and potentially in danger.
Consumers believe that over-the-counter supplements are regulated. This assumption leads many to believe that all products that are “supplements” are safe. Consumers don’t understand that manufacturers don’t have to prove efficacy or safety the way prescription drugs do.
At present, products can allude to health “claims” despite having unproven benefits. There is no real requirement that the product be effective at anything. Though products cannot state they cure or treat anything, consumers are purchasing and ingesting them based upon some notion that they will have an effect.
There are no standards for concentrations of bioactives. Many over-the-counter supplements contain little, if any, of the compounds they claim are in the product. There are no safety standards at present, especially for drug-nutrient interactions, contraindications with prescription medications or other supplements, or certain health conditions.
I tell consumers they may be guinea pigs for the supplement industry. They may be paying good money for products that may be little more than placebos.
Dr. Robert Wergin
President of the American Academy of Family Physicians
Full quote: “Vitamin and herbal dietary supplements constitute a booming business, and with that business comes responsibility.”
Partial quote: “Some products may not contain what the label claims…”
Vitamin and herbal dietary supplements constitute a booming business, and with that business comes responsibility. Supplements should contain exactly what they purport to contain.
Currently, some products may not contain what the label claims. Consumers can protect against this issue by purchasing products that have the USP verified dietary supplement mark on the packaging.
Steve Mister
President and CEO, Council for Responsible Nutrition
Full quote: “The government agencies have the tools and we’d like to see them use those tools.”
Partial quote: “Our industry has a strong safety profile…”
The mainstream dietary supplement industry encourages fuller implementation and enforcement by the FDA and the Federal Trade Commission of the current laws, which cover all facets of dietary supplement manufacturing, labeling, marketing, and post-market surveillance.
Our industry has a strong safety profile, and the law provides an appropriate regulatory framework that allows for consumer access to a wide variety of affordable, high quality, safe, and beneficial dietary supplement products. The government agencies have the tools and we’d like to see them use those tools.
Kasra Pournadeali, N.D.
President, American Association of Naturopathic Physicians
Full quote: “The majority of companies, especially those providing supplements directly to naturopathic physicians, produce a consistently high-quality product.”
Partial quote: “Dietary supplements have their place in promoting health…”
Dietary supplements have their place in promoting health. In recommending dietary supplements to patients, naturopathic physicians depend on high-quality products. This means the products must meet FDA current good manufacturing practices, such as the label claim for active ingredients. The majority of companies, especially those providing supplements directly to naturopathic physicians, produce a consistently high-quality product.
Especially given the recent issues in New York state (where the attorney general used an inappropriate method of testing finished products), we support the FDA addressing this on a national level in order to protect consumer safety using its existing authority under the Dietary Supplement Health and Education Act.
Marty Mack
Executive deputy attorney general for regional offices of the New York State Attorney General’s office
Full quote: “When consumers take a dietary supplement, they should be able to do so with full knowledge of what is in that product.”
Partial quote: “(The standards) invite misconduct and fraud and fails to adequately assure consumers…”
When consumers take a dietary supplement, they should be able to do so with full knowledge of what is in that product, and confidence that every precaution was taken to ensure its authenticity and purity.
While the FDA exerts limited oversight over dietary supplements, those standards and their enforcement are much less rigorous than those for pharmaceutical products or even food additives. This invites misconduct and fraud and fails to adequately assure consumers that products are free of dangerous levels of contaminants.
To fully address the authenticity and purity issues plaguing the dietary supplements industry nationwide, however, it will take major regulatory changes at the federal level.
Ryan O’Malley
Spokesman, Academy of Nutrition and Dietetics
Full quote: “Americans spend billions of dollars on dietary supplements despite ongoing concerns regarding their safety and effectiveness.”
Partial quote: “The current regulatory regime is largely only reactive to problems…”
The Academy of Nutrition and Dietetics enthusiastically supports the National Institutes of Health’s Office of Dietary Supplements’ research on supplements and their efforts, along with the FDA, to ensure the safety of dietary supplements sold in the United States.
Americans spend billions of dollars on dietary supplements despite ongoing concerns regarding their safety and effectiveness. The current regulatory regime is largely only reactive to problems with supplements sold, but the Academy believes Americans who purchase dietary supplements to address a nutritional deficiency or for other purposes should be able to have confidence in the safety, quality, and verifiability of the supplements they consume.
Denine Stracker, M.P.H.
R.D.N., lecturer and blogger at Apples and Olives
Full quote: “The FDA currently lacks the power to effectively prevent fraud and abuse within the supplement industry. This has been a longstanding problem.”
Partial quote: “The claims touted on the supplement labels are inaccurate at best…”
The FDA currently lacks the power to effectively prevent fraud and abuse within the supplement industry. This has been a longstanding problem as well as a public health concern.
While the FDA can challenge supplement safety and labeling, this is typically done retroactively, after the product has been on the market. Supplements are sold to the public without prior safety reviews, and the argument that self-regulation is effective no longer holds a strong position. This is a fundamental flaw of the current regulation.
Since the Dietary Supplement Health and Education Act was passed in 1994, the supplement industry has gained immense power. The claims touted on the supplement labels are inaccurate at best and misleading at worst, leaving the consumer overwhelmed, misinformed, and potentially in danger.
Felicia D. Stoler, D.C.N., M.S., R.D.N., F.A.C.S.M.,
Nutritionist and exercise physiologist, author of “Living Skinny in Fat Genes: The Healthy Way to Lose Weight and Feel Great”
Full quote: “Consumers don’t understand that manufacturers don’t have to prove efficacy or safety the way prescription drugs do.”
Partial quote: “Consumers believe that over-the-counter supplements are regulated…”
Consumers believe that over-the-counter supplements are regulated. This assumption leads many to believe that all products that are “supplements” are safe. Consumers don’t understand that manufacturers don’t have to prove efficacy or safety the way prescription drugs do.
At present, products can allude to health “claims” despite having unproven benefits. There is no real requirement that the product be effective at anything. Though products cannot state they cure or treat anything, consumers are purchasing and ingesting them based upon some notion that they will have an effect.
There are no standards for concentrations of bioactives. Many over-the-counter supplements contain little, if any, of the compounds they claim are in the product. There are no safety standards at present, especially for drug-nutrient interactions, contraindications with prescription medications or other supplements, or certain health conditions.
I tell consumers they may be guinea pigs for the supplement industry. They may be paying good money for products that may be little more than placebos.
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