MAHO is a coalition of independent natural product retailers, manufacturers and brokers who work together to preserve our industry and to protect our rights to do business. By working shoulder-to-shoulder we become stronger as an industry. With your participation we continue to effect policy change and ensure that we maintain your right to sell products, and the rights of your customers to make healthy choices.
MAHO represents your store’s interests at your state capital. Get involved, join us! Together we will positively affect the future of the natural products industry and in particular Natural Product Brick and Mortar Retailers! Our legacy to our successors is to preserve and protect the industry, as our predecessors have done for us.
What You Need To Know About Your Industry and The Safety Of Supplements
Extensive Regulations And Science Already Exist On The Safety Of Dietary Supplements
- Dietary supplements are foods. Food safety laws already exist to ensure the safety of foods. The new FSMA laws enhance food safety.
- The safety of dietary supplements is enhanced by the Dietary supplement cGMPs.
- These regulations regulate the safe manufacture of supplements and also protect against contamination and adulteration [21CFR110 and 111]
- The DSHEA law assures the safety of supplements on the market prior to 1994. These supplements have been now sold for almost 20 years, with many of them having being used by humans for thousands of years.
- The safety of vitamins and minerals, which are the majority of supplements used, has been established [Dietary Supplement Fact Sheets, Office of Dietary Supplements, NIH].
- The labeling of supplements is covered by labeling laws [NLEA & DSHEA regulations].
- The Adverse Event reporting regulations provide an additional mechanism for the reporting of serious adverse events associated with supplement use.
- There is both under-reporting and over-reporting of adverse events. In addition, many of the adverse events are not related to the supplement. In any case, the numbers are small relative to supplement use and are not indicative of a general problem.
- New ingredients are covered by the GRAS and NDI portions of existing regulations [FD&C Act, DSHEA]
There Needs To Be Increased Education And Enforcement Of Existing Regulations:
- There will always be individuals and corporations trying to flout the regulations or are unfamiliar with the regulations, as with any law.
- The regulations covering dietary supplements are enforced by the FDA and other Federal Agencies.
- Enforcement has been stepped up. The FDA is finding significant non-compliance with the regulations. However, FDA compliance is spotty and there is insufficient follow-through. Congress should promote enhanced enforcement through appropriations and other means.
- Both FDA and industry are working to educate industry about the regulations. The industry trade organizations hold a number of educational events each year. FDA participates in these events. The challenge is that many of the individuals and corporations that flout the law don’t attend these events.
- A recent webinar on reporting adverse events attracted over 600 registrants and over 400 attendees. With respect to the reporting of SAERs, it is difficult to assess, but there appears to be both under-reporting and over-reporting. Again, more education and enforcement is the solution.
Sufficient regulations and science exist supporting the safety of supplements. Greater education and enforcement is the solution. Dietary Supplements Have Been Safely Regulated Since 1994
1994 The Dietary Supplement Health and Education Act (DSHEA)*
- Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA
- GMPs were fully implemented between June 2008 and June 2010
- Continues to define dietary supplements as a special Food category
- Regulates labels
- All claims must be truthful and not misleading
- All ingredients must be on the labels
- Documentation to prove “structure-function” claims must be maintained
- Approves pre-existing dietary ingredients already on the market as of October 15, 1994
- Common vitamins, minerals, herbs
- Grandfathering” was twice applied to pharmaceuticals already on the market: The 1938 Food, Drug and Cosmetic Act & 1962 Kefauver-Harris Amendments
- Requires pre-market submission to the FDA of all New Dietary Ingredients marketed after October 15, 1994
- The agency questions the majority of submissions
- The agency has the power to reject applications; and has done so
- This is analogous to pharmaceuticals where all drugs entering the market after October 10, 1962 require an FDA submission/approval process