Supplement Regulations

FDA actions post-marketing

They monitor safety and voluntary dietary supplement adverse even reports. They also oversee product info such as: labeling, claims, package inserts, accompanying literature. They may conduct research and find unlisted ingredients and warn consumers but does not have the authority to issue a recall w/o mfr's cooperation.

NDI (FDA definition)

"New Dietary Ingredient" It was not sold in the U.S> in a dietary supplement before Oct. 15, 1994 and meets the following: It can be a vitamin, mineral, herbal/botanical, amino acid, concentrate/metabolite/constituent/extract, or a substance to supplement the diet by increasing the total dietary intake (enzymes or tissues from organs or glands)

Labeling

-"structure-function" claims allowed -Health claims only allowed when research validates, infrequently used on supplements -Law allows marketing health benefits w or w/o scientific documentation -Not required to warn possible side effects -It requires the not evaluated by the FDA disclaimer

Supplement Industry

-+ $22 billion -Almost 34 million americans from professional athletes to the elderly -2007 a study found 25% of the 58 supplement samples tested contained steroids or stimulants banned by the World Anti-Doping Agency -Earlier test: 15% of the 634 supplements would cause the athlete to test positive.

DSHEA concerns

-Basic format for ingredient labeling and nutrition labeling is not addressed -FDA exempted dietary supplements from listing all ingredients in descending order by weight. -All ingredients need to be listed but not necessarily as part of a consolidated ingredient list -The label can be provided "in a manner which is appropriate for the product" -FDA's limited resources limit its ability to take effective enforcement action -Act draws a crude distinction b/w food and drugs. It defines therapeutic and pharmacologically-active products as foods and are exempt from the FDA's drug regulation. -Any claim can be used w/o any persuasive clinical evidence but it must be accompanied by: "These statements have not been evaluated by the Food and Drug Administration" -There are no standardization of active ingredient(s) in multi-chemical products -No mandatory purity guarantees -No premarketing requirements before sale. -Once on sale, there is little ability for the FDA to issue cease-sale orders and recalls. It requires a significant number of problems or death identified (ephedra)

Supplement vs drug

-Drugs need to have research to prove safety and efficacy before it goes to the market and it requires at least 8 yrs. -Supplements require no research, it can happen in less than 3 months.

Ingredient control

-Mfr mainly rely on supplier honesty and many outsource manufacturing. -Those who control manufacturing use in-house testing to validate ingredient purity. -Most diet aids use caffeine, yerba mate, green tea, and yohimbine (tree bark)

Regulatory issues

-No registration of supplements w FDA required -No approval by FDA required and they FDA is responsible from action against any unsafe product once on the market. -Safety is basically monitored through consumer complains *Ephedra is an example, it marketed weight loss but people died bc of cardiac issues *Star caps had a diuretic but since it was imported from china, it was not specified, athletes were dying.

Research

-The act required the NIH to fund supplement research *echinacea (colds) or chodroitin sulfate (joint pain) have not been proven, studies fail to prove claims but they were only done after they were on the market.

DSHEA congress conclusions

-~50% americans use them -They are safe w/in a broad range of intake, safety problems are rare -Action will be taken if products are unsafe/adulterated -Govt. should not impose unreasonable regulatory barriers limiting or slowing down safe products and accurate info to consumers.

DSHEA supplement definition

Before: drugs or food additives that were easily pulled from the market. After: they might not be regulated as food additives or drugs under most circumstances. Quality standards for mfr's is set under a bill that covers Good Manufacturing Practices (GMP)

DSHEA

Dietary Supplement Health Education Act, 1994 It amended federal food, drug and cosmetic act and defined "dietary supplements" as a separate regulatory category. Many regulations were lifted and mfr's are now responsible for safety and are not required to provide proof of purity, safety or efficacy, or FDA approval However, they are required to notify FDA NDI's It prohibits the FDA from banning dubious supplement ingredients as "unapproved food additives" (Previous FDA's strategy) *Big marketing campaigned helped it be passed, it told people they would not have the liberty to buy supplements and it would put retailers out of business.

DSHEA benefits

It ensures continued access to safe products made to quality standards. -Allows for increased dissemination of information about the health benefits -It established the Office of Dietary Supplements w/in NIH.

FDA Actions before marketing

It is required to inspect processing plants and provide proof if problems present.

DSHEA labeling

It must include: -Descriptive name of the product stating it is a "supplement" -Name and place of business of mfr, packer, or distributor -Complete list of ingredients -Net contents of the product -Nutrition labeling in he form of a supplements fact panel. -Serving size is required

FTC regulation

It regulates dietary supplement advertising. It can prosecute mfr's for fraud. Some actions: -Sensa: fined w payment used for refunds to costumers who bought it. sprinkle it on food and you eat less. -LOccitane: sliming cream -HCG diet: Human Csomething Hormone diet -LeanSpa, LLC: promoted acai berry and "colon cleanse" weight-loss supplements *In 2014, weight-loss marketers paid approx. $34 million for consumer redress.

Office of Dietary Supplements

It was established w/in NIH, to support supplements by consolidating supplement research and advising the govt. on issues related to dietary supplements.

DSHEA requires

Manufacturers need to use good processes and make no unproven claims on the labels.

NDI approval

Needs to be submitted to the FDA: -at least 75 days before introduces to the market -Conclusion that the ingredient and the supplement containing it is expected to be safe -Provide amount to be used -Conditions of use -History of use or other evidence of safety when used under the conditions recommended or suggested in the label. -Any reference to published materials translated to english if necessary.

Supplement

Something that supplies one or more essential nutrients missing from the diet. They can be: vitamins, minerals, herbs/botanicals, amino acids, and other products that do not contain approved pharmaceutical drugs and don't claim to treat a disease. -Dieters, athletes, and the elderly are the most frequent users.

DSHEA regulates

Supplements under a diff. set of rules than those covering "conventional" foods and drug products. This makes the supplment mfr's responsible for ensuring the product's safety before it is marketed. If a problem is encountered the FDA takes action after it reaches the market but it is much stricter than what is applied to conventional foods. *unsafe foods and drugs do not reach the market.