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Busting the Myth of No Regulation

December 2016

Occasionally, you may read an article or hear a report on television that makes a statement regarding the natural supplement industry in a negative light. The article or report may make mention that supplements are “unregulated”. Usually this type of report is disseminated by either a company or agency that has something to gain if supplements were not allowed to be sold over the counter. These types of reports and statements, I feel, are grossly misleading to you, our customer.

The natural health industry, including the Natural Products Association and the Center for Responsible Nutrition have long been fighting against this type of misinformation, and fighting to correctly inform the public that the industry is regulated by the FDA, and in fact has been since 1994.

In response to demand, then Senators Orrin Hatch and Tom Harkin introduced a bill regarding supplement manufacturing and labeling. This bill was signed into law in 1994 under the U.S. Food and Drug Administration regulation and called the Dietary Supplement Health and Education Act (DSHEA).

The FDA regulates both finished dietary supplement products and dietary ingredients. It regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
  • FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

· Should safety problems arise after marketing, DSHEA makes "adulterated" any dietary supplement that creates a "significant or unreasonable" risk to consumers, thereby subjecting it to FDA enforcement action. Further, in particularly compelling cases, DSHEA allows the Secretary to ban a dietary supplement if she finds it to be an "imminent hazard."

· Finally, as a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice (GMP) regulations for dietary supplements. Such regulations would be intended to establish a mechanism to help assure purity and consistency in dietary supplement products.

· Regarding labeling, DSHEA seeks to provide consumers with information to help guide personal choice. This includes specially tailored requirements for ingredient labeling and nutrition labeling.

· DSHEA also provides for use of claims to affect the structure or function of the body, claims of general well-being from consumption of a nutrient or dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days after marketing, must be substantiated, and must be accompanied by the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

· Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.

Furthermore, the FDA Good Manufacturing Practice regulation states:

  • The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
  • The requirements include provisions related to:

· the design and construction of physical plants that facilitate maintenance

· cleaning

· proper manufacturing operations

· quality control procedures

· testing final product or incoming and inprocess materials

· handling consumer complaints

· maintaining records.

· Examples of product quality issues that GMP prevents are:

· dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary supplements that contain ingredients in amounts that are less than those listed on the label

· wrong ingredient

· other contaminant (e.g., bacteria, pesticide, glass, lead)

· foreign material in a dietary supplement container

· improper packaging

· mislabeled

In addition, there are plans for upcoming regulatory enforcement by the FDA of the New Dietary Ingredients Notification (NDI) which requires registration of all ingredients with proof of safety prior to manufacturing.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

So, yes, supplements are in fact regulated through the FDA. Now, with that being said, let me also state that although the FDA regulates the natural health industry it does not do so in the same manner that it regulates the pharmaceutical drug industry.

If supplements were regulated as prescription drugs, then many of the items you find in health food stores would disappear. You, the natural health consumer, would then be limited to very few supplement choices that could only be obtained through physician prescription, and most likely at exorbitantly high prices.

I recently had a gentleman come into the store with a prescription he had been given for a very common enzyme formulation typically available over the counter. He told me this prescription would have cost him almost $500.00 and that was after his insurance paid half. Yes, you are reading this correctly!

In addition to the FDA regulations, supplement manufacturers are subject to the Federal Trade Commission's strictest labeling guidelines which are in place to prevent false claims and uphold truth in advertising laws.

Yes, there have been instances where "fly by night" companies try to sell supplements on the internet that are subpar. These companies are quickly shut down when they attempt to circumvent FDA and FTC regulations.

In conclusion, I hope that this information has been helpful in understanding that the supplement industry does in fact have laws in place that it has to adhere to for the safety and efficacy of all the products you love and trust.

Sincerely, and with passion to help people live healthier, more vibrant lives,

Brenda Valen, B.S., CNC, CNHP

Owner, Gulf Coast Nutrition