Dietary Supplement and Education Act of 1994 Lawyers

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 Dietary Supplement and Education Act of 1994 Lawyers

The Dietary Supplement and Education Act of 1994 (DSEA) defines a dietary supplement as any item, other than tobacco, that contains a vitamin, a plant, an amino acid, or a combination of those substances and is used to replace food.

These supplements must be identified as nutritional supplements on the front panel and typically come in pill, tablet, or liquid forms, such as herbal supplements and energy drinks.

Background

The American Congress considered legislation that would have given the Food and Drug Administration (FDA) more authority in the late 1980s and early 1990s. The Nutrition Advertising Coordination Act of 1991, one of these laws, would have strengthened the rules governing supplement labeling. Many health food businesses reacted to the proposed legislation by lobbying lawmakers to reject it and informing the public that the FDA would outlaw dietary supplements.

In a well-known commercial, Mel Gibson was raided and detained by FDA inspectors for taking vitamin C supplements.

Gerald Kessler, the CEO of the nutritional supplement company Nature Plus and one of the lobbying group’s leaders, claimed that the FDA has had “a prejudice against the supplement business for 50 years.”

The Dietary Supplement Health and Education Act was introduced in 1994 by Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah). When President Bill Clinton signed the Act into law on October 25, 1994, he noted that “after several years of intense efforts, manufacturers, nutrition experts, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”

Hatch received considerable financial backing from companies that produce dietary supplements, such as multi-level marketing companies XanGo and Herbalife.

What Is a Supplement?

The DSHEA defines a “dietary supplement” as: A product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredients, such as a vitamin, mineral, herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the ingredients above.

Dietary supplements must be identified on the label as such, be designed for oral consumption, and not be promoted for use as regular food, the only component of a meal, or as part of a diet.

In addition, unless it was sold as a food or dietary supplement prior to such approval or authorization, it cannot be approved or investigated as a novel medication, antibiotic, or biologic.

Dietary supplements are considered to be food under the DSHEA, with the exception of the drug definition.

Labels for Dietary Supplements

The display of textual, printed, or visual content on the supplement container is referred to as a “label.” The following details must be present on dietary supplement labels in accordance with the DSHEA and other federal regulations:

  • A statement of identity with the phrase “dietary supplement” in it. The name of the dietary ingredient may be used in place of the word “dietary” (e.g., “ginseng supplement”)
  • A “Supplement Facts” panel with nutrition data that includes the product serving size, the quantity, and the percent daily value, if determined, of each dietary ingredient.
  • If a supplement comprises a proprietary blend, it must indicate the blend’s net weight and each ingredient’s weight in descending order.
  • The plant component used if it’s a herb or botanical
  • The maker, packer, or distributor’s name and place of business
  • A comprehensive list of ingredients by their typical or popular names, either in descending order of prominence or with the source of the dietary ingredient in the “Supplement Facts” panel following the name of the dietary ingredient (for example, calcium (from calcium carbonate)).
  • Information regarding safety that is deemed “material” to the potential effects of using the supplement
  • The disclaimer, “The Food and Drug Administration has not reviewed this claim.”
  • The disclaimer, “This item is not meant to be used to identify, treat, prevent, or cure any illness.”
  • The disclaimer, “if the supplement makes a claim about how the body will change in terms of structure or function (a “structure/function claim”), lists the general health benefits for a condition associated with nutritional deficiencies.

Manufacturers have the option to add extra information to labels (such as claims and declarations of quality assurance) and choose where that information is displayed.

Regulatory Analysis

In accordance with the act, supplement producers are not required to wait for FDA approval before marketing dietary supplements that were sold in the US before 1994.

According to 21 USC 350b(d), dietary ingredients that have not been grandfathered are New Dietary Ingredients, and FDA evaluation (not approval) is required prior to their marketing for notifications that provide acceptable evidence of their safety or reasonable expectations of their safety. The herbal supplement business has challenged these laws as being unfairly onerous; some believe they go against the law’s initial purpose to give the sector leeway to sell supplements as foods.

What Must a Dietary Supplement’s Nutritional Label Contain?

A dietary supplement’s nutritional label must contain:

  • Ingredients: A nutritional supplement, like DMAA or Arbonne, must declare all of its components, along with the quantity of each component, separately and collectively. The label must specify which portion of the plant each of the many botanicals utilized as ingredients came from.
  • Nutritional Content: The FDA’s daily intake recommendations for large amounts of dietary components must first be listed. The list of dietary elements that are present at large levels but for which the FDA has not issued daily intake recommendations should come next. The amount of each dietary component per serving should be included in the list of ingredients in the nutrition facts section.

What May Not Be Included on a Dietary Supplement’s Ingredient List?

Dietary supplement labels are not allowed to make any false or deceptive claims about their benefits. For instance, a nutritional supplement claiming to “cure cancer” should not be sold in a store. The FDA must provide its approval before the dietary supplement maker can declare any benefits on the label. If the supplement’s label contains a benefit claim that the FDA has not approved, it must be followed by a disclaimer to the effect that the FDA has not approved the claim.

Reception

According to certain studies, the public has little access to safety information about dietary supplements accessible on the market.

Other studies have revealed that the FDA’s network for responding to complaints of adverse events in the dietary supplement business is insufficient. In 2010, Senator Hatch defeated a bill that would have mandated tracking illnesses linked to supplement use.

What Should I Do If I Bought and Used a Dietary Supplement and Discovered Later That the Labeling Was Incorrect?

The dietary supplement maker is in charge of adhering to DSEA regulations. If you discover that you have been taking a supplement with incorrect labeling, you should file a complaint with the FDA and the manufacturer.

A defective products attorney can be someone else you want to speak with. Your lawyer can inform you of your alternatives and assist you in choosing the best line of action. If you sue the manufacturer, you might also be entitled to financial compensation for your losses.

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